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نوبو | دراسات سريرية

تعود قصة نوبو إلى عام 1981 عندما تم تطوير منتجات لإنقاص الوزن بشكل فعال وآمن.

اسم "نوبو" هو مزيج من الكلمتين "القوة الغذائية" أو "Nutritional power"

لقد تم تطوير نوبو في مستشفى هفيدوفر في الدنمارك من قبل باحث السُمنة الرائد الدكتور فليمنق بالتعاون مع شركة أُولف مارك، والتي كنت المسؤولة عن التسويق لنوبو.


منذ أوائل ثمانينات القرن الماضي، تم اختبار منتجات نوبو المنخفضة جدًا بالسعرات الحرارية وتم اعتمادها في أكثر من 35 تجربة سريرية، يتم تطوير نوبو واختبارها باستمرار من قبل مجموعات بحث في المستشفيات في جميع انحاء الدنمارك.


تتكون النظرة العامة عن نوبو من دراسات سريرية يتم اجرائها بشكل مستمر منذ إنشاء نوبو وحتى الوقت الحاضر (سبتمبر 2018)، تناولت الدراسات العديد من المواضيع المختلفة والمهمة التي تم فحصها واختبارها.

عند علاج السمنة من المهم الأخذ بالاعتبار العوامل المؤثرة على ذلك مثل: كتلة العظم، وكتلة العضل، والكتلة الدهنية، وعوامل خطر الإصابة بأمراض القلب والأوعية الدموية، والجوع وما إلى ذلك.


تنتج نوبو كلًا من: منتجات نظام نوبو المنخفضة جدًا بالسعرات الحرارية "VLCD" وبدائل الوجبات "ون ميل" والتي يتم استخدامها بنجاح في الدنمارك لأكثر من أربعة عقود. بالرغم من تغيير مكونات منتجات الـ"VLCD" عن الأيام الأولى (يحتوي الآن على مسحوق الكولين والألياف وقشر السيليوم) إلّا أن نتائج الدراسات التي أُجريت في ذلك الوقت لا زالت مرتبطة ارتباطًا وثيقًا في المنتجات الحالية، ولم تؤدي تغيير المكونات إلى اختلاف نتائج الدراسات.


يستمر استخدام نوبو في الدراسات السريرية من قبل


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2010-حتى الآن

Re-evaluation of konjac gum (E 425 I) and konjac glucomannan (E 425 II) as food additives

- by European Food Safety Authority (EFSA) (2017)

Abstract

The present opinion deals with the re-evaluation of konjac (E 425), comprising konjac gum (E 425 i) and konjac glucomannan (E 425 ii) when used as food additives. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that current use of konjac (E 425) was limited in all food categories to maximum permitted level (MPL) of 10 g/kg, and that the calculated indicative refined exposure assessment for all population groups was below 0.1 mg/kg body weight (bw) per day for the general population (mean and high level). Konjac gum and konjac glucomannan were unlikely to be absorbed intact and were significantly fermented by intestinal microbiota. The available database on toxicological studies was considered limited, however, no relevant adverse effects were seen in rats and dogs in 90-day feeding studies according to the SCF, the no-observed-effect level (NOEL) in rats being 1,250 mg konjac glucomannan/kg bw per day. Konjac gum and konjac glucomannan were of no concern with respect to the genotoxicity. After a daily dosage of 3,000 mg in adults for 12 weeks, several individuals experienced abdominal discomfort including diarrhoea or constipation. The Panel concluded that there was no need for a numerical acceptable daily intake (ADI) and that there was no safety concern for the general population at the refined exposure assessment for the reported uses of konjac gum (E 425 i) and konjac glucomannan (E 425 ii) as food additives under the current conditions of use of 10 g/kg. The Panel agreed with the conclusions of the SCF (1997) that the uses of konjac (E 425) as an additive at the levels up to 10 g/kg in food are acceptable, provided that the total intake from all sources stays below 3 g/day. For the full study, click here.


Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction

- by V. R. Trivedi et al. (2016)

Abstract

Chitosan is a dietary fiber that acts by reducing absorption and thus as a means for controlling weight. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy. The primary objective of the present study was to evaluate the efficacy and safety of chitosan from the fungal origin in the treatment of excess weight in the absence of dietary restrictions. For the full study, click here.


KiOnutrime-CsG® – The proven weight management tool

- af KitoZyme (2015)

Introduction

KiOnutrime-CsG® is a natural ingredient that is scientifically proven to help people to manage their weight. In a recently completed clinical trial1, it was found that overweight subjects consuming KiOnutrime-CsG® lost an average of 3.2kg over three months. This is compared with a small weight increase on average in the control group.

Produced by KitoZyme at its manufacturing facility in Belgium, KiOnutrime-CsG®, works by safely preventing some of the fat in food from being absorbed by the body. It is a cationic (positively charged) biopolymer that binds with anionic (negatively charged) molecules, such as fats and fatty acids and obstructs the emulsification and absorption of cholesterol. Taken just a few minutes before a meal, KiOnutrime-CsG® will bind dietary fat in the stomach to form a gel that is later excreted naturally without being absorbed. A previous study carried out using a lab-based model of the human gut, showed that KiOnutrime-CsG® can bind 42% of the fats ingested in a typical meal2, as shown below in Figure 1. The latest human study, which is awaiting publication in a peer-reviewed journal, confirms that this mechanism has a statistically significant impact on weight loss in healthy overweight people.


Read more about the studies here, click here.


Adverse effects of plant food supplements and botanical preparations: a systematic review with critical evaluation of causality

- by C. Di Lorenzo et al. (2014)

Aims

The objective of this review was to collect available data on the following: (i) adverse effects observed in humans from the intake of plant food supplements or botanical preparations; (ii) the misidentification of poisonous plants; and (iii) interactions between plant food supplements/botanicals and conventional drugs or nutrients.

Methods

PubMed/MEDLINE and Embase were searched from database inception to June 2014, using the terms ‘adverse effect/s’, ‘poisoning/s’, ‘plant food supplement/s’, ‘misidentification/s’ and ‘interaction/s’ in combination with the relevant plant name. All papers were critically evaluated according to the World Health Organization Guidelines for causality assessment.

Results

Data were obtained for 66 plants that are common ingredients of plant food supplements; of the 492 papers selected, 402 (81.7%) dealt with adverse effects directly associated with the botanical and 89 (18.1%) concerned interactions with conventional drugs. Only one case was associated with misidentification. Adverse effects were reported for 39 of the 66 botanical substances searched. Of the total references, 86.6% were associated with 14 plants, including Glycine max/soybean (19.3%), Glycyrrhiza glabra/licorice (12.2%), Camellia sinensis/green tea ( 8.7%), and Ginkgo biloba/ginkgo (8.5%).


Conclusion

Considering the length of time examined and the number of plants included in the review, it is remarkable that: (i) the adverse effects due to botanical ingredients were relatively infrequent if assessed for causality; and (ii) the number of severe clinical reactions was very limited, but some fatal cases have been described. Data presented in this review were assessed for quality in order to make the results maximally useful for clinicians in identifying or excluding deleterious effects of botanicals. For the full study, click here.


Scientific Opinion on the substantiation of a health claim related to a standardized aqueous extract from white kidney bean

- by European Food Safety Authority (EFSA) (2014)

Abstract

Following an application from InQpharm Europe Ltd, submitted for authorization of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a standardized aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight. The Panel considers that the food is sufficiently characterized. A reduction in body weight is a beneficial physiological effect for overweight individuals. The applicant identified a total of four human intervention studies which investigated the effects of the aqueous extract from white kidney bean on body weight as being pertinent to the claim. No conclusions could be drawn from two of these four studies. In weighing the evidence, the Panel took into account that one human intervention study showed an effect of the standardised aqueous extract from white kidney bean in reducing body weight when consumed for 12 weeks, that the reduction in body weight was mostly through a reduction in body fat and that the effect of the standardized aqueous extract from white kidney bean on body weight was supported by a second study of shorter duration. However, the Panel also took into account that the first study was at risk of bias, that the supportive study suffered from methodological limitations and that no evidence was provided for a mechanism by which the standardized aqueous extract from white kidney bean could exert the claimed effect. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of the standardized aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight. For the full study, click here.


Assessment report on Zingiber officinale Roscoe, rhizoma

- by European Medicines Agency (2012)

Introduction

Ginger (Zingiberis rhizoma) consists of the whole or cut rhizome of Zingiber officinale Roscoe (Zingiberaceae), with the cork removed, either completely or from the wide, flat surfaces only [European Pharmacopoeia 2011]. Ginger plants have been extremely popular – for cooking as spice and to treat a host of ailments – throughout Asia, especially in India and China, for over 5000 years. The species Zingiber officinale originates from Southeast Asia. It is not known to occur wild [Teuscher 2006; Langner et al. 1998; Germer et al. 1997]. It is a perennial herb, up to 1.5 metre in height, with asymmetric flowers. Due to the long period of breeding in different continents, different types of the species have developed. The herbal substance ginger, that complies with the monograph of the European Pharmacopoeia, originates from the West Indian type (Jamaica-ginger) with the cork removed or from Indian types (Bengal-ginger, Cochin-ginger) peeled on the flattened sides only. Constituents: Volatile oil 1-4 % (minimum 15 ml/kg essential oil (anhydrous drug) according to the Ph. Eur.). More than 100 compounds are identified, most of them terpenoids mainly sesquiterpenoids (α-zingiberene, β-sesquiphellandrene, β-bisabolene, α-farnesene, ar-curcumene (zingiberol) and smaller amounts of monoterpenoids (camphene, β-phellandrene, cineole, geraniol, curcumene, citral, terpineol, borneol). The composition of the oil depends on the origin of the material [Afzal et al 2001; Ahmad et al. 2008; Ali et al. 2008; Chen & Ho 1988; Connell 1970; Erler et al. 1988; Lawrence 1984]. The pungent principles, the gingerols (4-7.5%) are a homologous series of phenols. The principal one of these is 6-gingerol. Gingerols with other chain-lengths, e.g., 8-gingerol and 10-gingerol, are present in smaller amounts. During drying and storage, gingerols are partly dehydrated to the corresponding shogaols which may undergo further reduction to form paradols, also present in stored ginger [Afzal et al. 2001; Bradley 1992; Connell 1970; Farthing & O’Neill 1990; Jolad et al. 2005; Kim et al. 2008; Steinegger & Stucki 1982]. Other constituents are starch, up to 50%, lipids 6-8%, proteins, and inorganic compounds [Awang 1992; ESCOP 2009]. The requirements of the US Pharmacopoeia for ginger are: gingerols and gingerdiones not less than 0.8%, volatile oil not less than 1.8 ml per 100 g, starch not less than 42% and shogaols not more than 0.18% [Bradley 1992; USP 2009]. For the full study, click here.


A Review on Pharmacological and Phytochemical Properties of Zingiber officinale Roscoe (Zingiberaceae)

- by Gaurav Kumar et al. (2011)

Introduction

Herbs and plants have been in use as a source of therapeutic compounds in traditional medicinal system since ancient time. Medicines plants play an important role in traditional health care systems as well as in international herbal and pharmaceutical markets. The medicinal value of these plants lies in some chemical substances that produce a definite physiological action on the human body. The most important of these bioactive constituents of plants are alkaloids, tannins, flavonoids and phenolic compounds. Z. officinale (Zingiberaceae) is an important plant with several ethnomedicinal and nutritional values therefore, used extensively worldwide as a spice, flavouring agent and herbal remedy. Traditionally, Z. officinale is used in Ayurveda, Siddha, Chinese, Arabian, Africans, Caribbean and many other medicinal systems to cure a variety of diseases viz, nausea, vomiting, asthma, cough, palpitaion, inflammation, dyspepsia, loss of appetite, constipation, indigestion and pain. In last few decades, Z. officinale is extensively studied for its medicinal properties by advanced scientific techniques and a variety of bioactive compounds have been isolated from the different parts of the plant and were analysed pharmacologically. The plant is reported for antimicrobial activity, anticancer activity, antioxidant activity, antidiabetic activity, nephroprotective activity, hepatoprotective activity, larvicidal activity, analgesic activity, anti-inflammatory activity and immunomodulatory activities. The present review is focused an overall outline of the morphology, distribution, phytochemistry and medicinal properties of Z. officinale and its future prospects for the further scientific investigation for the development of effective therapeutic compounds. For the full study, click here.


The effect of weight loss in obese patients with heart failure – a pilot study

- by Mikkelsen, M. G. (2011).

Introduction

Dietary recommendations in heart failure management are contradictory to findings established by the obesity paradox. The objective of this study was to investigate if a weight reduction could reduce symptoms of heart failure; thus resulting in an improvement of body composition, plasma lipid profile, and functional status and thereby positively affect cardiac function.

Methods

We enrolled 26 obese patients with heart failure and NYHA II or III. They were randomly assigned to adhere to a low-calorie diet (Nupo VLCD: 700 kcal/day + 100 kcal of supplementary food) or a conventional diet for 12 weeks. In the study, we assessed body weight and -composition, plasma lipid profile, NT-proBNP, functional status, and quality of life.

Results

Of the 26 patients, 18 completed the study (11 in the intervention group and 7 in the control group). The mean weight loss with the low-calorie diet (LCD) was 11.3% of initial body weight and the difference in mean weight loss between the low-calorie diet group and conventional diet group was 11.7 kg at the end of the study (95% CI: 6.8, 16.6, p<0.0001). Patients following the low-calorie diet significantly reduced their body mass index (p<0.0001, 95% CI: 2.3, 5.3), waist circumference (p<0.0001, 95% CI: 5.9, 15.3), and hip circumference (p<0.0010, 95% CI: 5, 15.2,) compared to the patients following the conventional diet. The walking distance significantly improved between baseline and week 12, the between-group difference amounted to 172m after 12 weeks p<0.0005. There was a significant mean difference for cholesterol- (p<0.0006), triglyceride-(p<0.0100), and low-density lipoprotein (p=0.0265) concentrations between baseline and week 8. Mean differences in plasma lipid levels were not significant at week 12.

Conclusion

In this small pilot study, a low-calorie diet led to a significant improvement in body weight and -composition and functional status in patients with 

heart failure. Larger studies need to confirm these preliminary findings.


For the full study, click here.

.Scientific Opinion on the substantiation of health claims related to konjac mannan (glucomannan) and reduction of body weight, etc

- by European Food Safety Authority (EFSA) (2010)

Summary

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to konjac mannan (glucomannan) and reduction of body weight, reduction of post-prandial glycaemic responses, maintenance of normal blood glucose concentrations, maintenance of normal (fasting) blood concentrations of triglycerides, maintenance of normal blood cholesterol concentrations, maintenance of normal bowel function and decreasing potentially pathogenic gastrointestinal microorganisms. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from the Member States or directly from stakeholders. The food constituent that is the subject of the health claims is konjac mannan (glucomannan). The Panel considers that konjac mannan (glucomannan) is sufficiently characterized. For the full study, click here.


2000-2009

Comparable reduction of the visceral adipose tissue depot after a diet-induced weight-loss with or without aerobic exercise in obese subjects: a 12-weeks randomized intervention study

- by T. Christiansen, et al. (2009).

Introduction

Obesity, in particular excess visceral adipose tissue (VAT), is associated with metabolic syndrome resulting in increased morbidity and mortality. By contrast, accumulation of body fat in the subcutaneous gluteal-femoral adipose tissue (GFAT) is generally less associated with health problems or may even mediate some protection against cardiovascular diseases. These findings suggest that fat distribution and particularly the ratio between VAT and GFAT may be of importance for obesity-related health complications. Weight loss with preferential effect on the visceral adipose tissue (VAT) depot could have important clinical benefits. In this study, we investigated the independent and combined effect of regular exercise and diet-induced weight loss on body fat distribution.

Methods

Randomized control design of i) exercise-only (EXO; 12 weeks of exercise without diet-restriction), ii) hypocaloric diet (DIO; 8 weeks of very low energy diet (VLED 600 kcal/day (Nupo)) followed by 4-weeks weight maintenance diet) and iii) hypocaloric-diet and exercise (DEX; 8 weeks VLED 800 kcal/day (Nupo + supplement of 150-200 kcal) + a 4-week weight maintenance diet combined with exercise throughout the 12 weeks). Seventy-nine obese males and females were included. Body fat distribution was quantified by magnetic resonance imaging (MRI)-technology.

Results

In the EXO group, the weight loss (3.5 kg) and the relative reduction in VAT (18%) was significantly lower compared with the weight losses in the DIO and DEX groups (12.3 kg; P≤0.01) and to the reduction in VAT (30-37%; P≤0.001). In all the three groups, the relative reduction of VAT was higher as compared with the reduction in fat mass (FM; combining all fat depots determined by MRI; P≤0.01 for all comparisons). The changes in VAT were associated with changes in FM and related to the initial VAT/FM ratio (r2=0.72; P≤0.01).


Conclusion

Exercise has no additional effects on the reduction of the VAT depot, compared with the major effects of hypocaloric diet alone. In addition, the effects of exercise per se on VAT are relatively limited. The effects on the VAT depot are closely associated with changes in total FM.


For the full study, click here.

Twenty-four-hour plasma tryptophan concentrations and ratios are below normal in obese subjects and are not normalized by substantial weight reduction

- by L. Breum, et al. (2003).

Introduction

Plasma tryptophan concentrations and the ratio of tryptophan to other large neutral amino acids (plasma tryptophan ratio) are reportedly low in obese subjects. The plasma tryptophan ratio predicts brain tryptophan uptake and serotonin production. If this is low in obese subjects, serotonin function may also below. Serotonin neurons in the brain participate in the control of appetite. In general, serotonin neurons function in neuronal circuits that diminish food intake. Plasma tryptophan concentrations and ratios have been measured only at single time points in obese subjects; it is not known whether low values for these two variables persist throughout a 24-h period. The objective of the study was to determine whether plasma tryptophan concentrations and ratios in obese subjects are lower than those in normal-weight subjects throughout a 24-h period and whether they increase when body weight is reduced.

Methods

The original group consisted of 18 obese patients and 18 sex- and age-matched non-obese subjects. 9 obese patients completed the weight-loss program and their age- and sex-matched nonobese counterparts formed the groups examined in the study. The obese subjects participated in a structured, outpatient weight-loss program to achieve ideal body weight. During the initial phase of the program, the subjects consumed a very low-energy diet (Nupo). When body weight had decreased to ≈ 130% of ideal body weight (6-17 mo) the patients were instructed to discontinue the VLCD and begin consuming a 5 MJ/d diet of normal food items. When ideal body weight was achieved or when no further weight could be lost, the patients were instructed to begin consuming a basic 8 MJ/d diet. Sampling in post-obese patients was performed after body weight had remained stable (±1.5 kg) for ≥ 1 mo after switching to the last diet program.


Plasma tryptophan concentrations and ratios were examined in obese subjects before, after weight loss, and in nonobese control subjects. Blood samples were drawn frequently throughout the 24-h period. An insulin tolerance test was also used to demine whether weight loss altered the ability of insulin to modify plasma concentrations of tryptophan and of the other large neutral amino acids.

Results

Plasma tryptophan concentrations and ratios in obese subjects were low at all times; these effects persisted after weight reduction. Plasma concentrations of all the large neutral amino acids decreased during insulin infusion in all the groups.

Conclusion

In relation to the present findings, such results predict that when serotonin transmission is low, appetite will be stimulated. The persistently lower plasma tryptophan ratios observed throughout the day and night in the obese subjects than in the normal-weight control subjects support the notion that brain tryptophan uptake and serotonin synthesis in obese subjects may be abnormally low. The fact that the plasma tryptophan ratio remains persistently low after weight reduction further suggests that the formerly obese may struggle against a biochemical signal oriented toward increased appetite and food intake. We conclude that the low 24-h plasma tryptophan ratios in obese and formerly obese subjects suggest that brain tryptophan uptake may be continuously diminished and may remain below normal despite weight reduction.


For the full study, click here.

1990-1999

Bone Loss Accompanying Voluntary Weight Loss in Obese Humans

- by L. Bjørn et al. (1994).

Introduction

Some studies have demonstrated that diet-induced weight loss is accompanied by a significant decrease in bone mineral density (BMD). Regional bone changes were not measured. The purpose of the present investigation was to measure changes in total and regional body composition in obese patients undergoing rapid weight loss on a low-calorie regimen.

Methods

Dual-energy x-ray absorptiometry was performed in 51 obese patients before and after 15 weeks on a low-calorie diet (Nupo, yielding 1.9 MJ for women and 2.4 MJ for men for 2 weeks. Thereafter a qualitatively free supplement of food and drink was allowed up to 4.2 MJ for women and 4.7 MJ for men). Of these patients, 39 were scanned 6 months later. Total and regional body bone mineral, fat mass, and fat-free mass were measured. In the control group, 9 normal volunteers were scanned with up to 23 kg lard distributed anteriorly, and 9 volunteers were scanned with 15 kg lard posteriorly. The lard was then gradually removed to simulate the fat loss found in the patient group.

Results

In the patient group, the mean weight loss was 12,273 g, the mean fat loss was 11,014 g, and the mean bone mineral loss was 171.6 g after 15 weeks. A close correlation between the fat loss and bone loss was found and calculated to be 16.5 g bone mineral per kg fat in the patient group, in contrast with 0.5 g bone mineral per kg fat in the control group. In the control group, 15 kg lard placed posteriorly had no statistically significant effect on the bone measurements. If weight and fat were regained at the scanning time 6 months later, the bone mineral was regained as well. Patients with further weight loss continued to lose bone mineral. One patient lost 754 g bone mineral in 9 months. Her weight loss was 45 kg in that period, and the bone mineral content remained within the range for normal women at her age. Methodologic and pathogenetic problems are discussed.

Conclusion

It is concluded that the observed bone loss should be regarded as physiologic normalization within acceptable limits accompanying a diet-induced weight loss in the obese.


For the full study, click here.

Effect of an energy-restrictive diet, with or without exercise, on lean tissue mass, resting metabolic rate, cardiovascular risk factors, and bone in overweight postmenopausal women

- by O. L. Svendsen, et al. (1993).

Introduction

Overweight is an independent predictor of cardiovascular disease (CVD) – the leading cause of death and disability in Western societies. Very little is known about the changes in overweight postmenopausal women since all studies previously have been performed in men and pre-menopausal women. Postmenopausal women are at increased risk of CVD; estrogen deficiency, an atherogenic lipid and lipoprotein profile, and fat distribution all play a role. Osteoporosis is another major cause of morbidity and mortality in this group. The consequences of weight reduction from dieting, with or without exercise, on bone in the osteoporosis are unknown. Thus, the aim was to study the effects of an energy-restrictive diet, with or without exercise, on body composition, major cardiovascular risk factors, and bone in overweight postmenopausal women.

Methods

In a longitudinal clinical study, 121 healthy, overweight postmenopausal women (age 53.8 ± 2.5 years, BMI 29.7 ± 3.1 kg/m2) were randomly assigned to 3 groups: control, a 4,200 kJ/d diet, or a 4,200 kJ/d diet with combined aerobic and anaerobic exercise. The diet consisted of an obligatory basis of the formula diet NUPO of 1.6 MJ daily (VLCD) combined with an additional energy com-consumption of up to 2.6 MJ from food freely chosen, according to a “counter diet system”. Body composition (measured by dual-energy x-ray absorptiometry), fat distribution, resting metabolic rate, blood pressure, serum lipids and lipoproteins, bone mineral densities, and markers of collagen and bone turnover were measured before and after 12 weeks of intervention.

Results

One hundred eighteen women completed the study. The mean loss of body weight (9.5 kg versus 10.3 kg, NS) was similar in the intervention groups, but compared with the diet-only group, the diet-plus-exercise group lost more fat (7.8 kg versus 9.6 kg, p ≤0.001) and no lean tissue mass (1.2 kg versus 0.0 kg, p ≤0.001). The resting metabolic rate (per kg wt) was increased in the diet-plus-exercise group compared with the control group (11% versus 4%, p≤0.009). The levels of serum triglycerides, total cholesterol, low-density lipoprotein, and very-low-density lipoprotein decreased, and the ratio of high-density lipoprotein to low-density lipoprotein increased by 20% to 30% in both intervention groups compared with the control group (p≤0.001). The systolic blood pressure dropped, and the waist-to-hip circumference ratio and abdominal-to-total body fat decreased in both intervention groups compared with the control group (10% p≤.003, and 3.5%, p≤0.0001). There were no consistent, major differences between the groups in terms of changes in total body, spinal, or forearm bone mineral densities, or in markers of collagen and bone turnover.

Conclusion

We conclude that, in overweight postmenopausal women, the addition of combined aerobic and anaerobic exercise to a high protein, energy-restricted diet preserves lean tissue mass, promotes physical fitness, and increases the resting metabolic rate and loss of fat. The diet, with or without exercise, led to profound improvements in serum lipids and lipoproteins, blood pressure, and fat distribution. The weight loss induced by the diet, with or without exercise, does not seem to have any major detrimental effect on bone.


For the full study, click here.

Dietary fiber added to a very low-calorie diet reduces hunger and alleviates constipation

- by A. Astrup et al. (1990).

Introduction

A very low-calorie diet (VLCD) as a nutrition, powder formula diet is being widely used for the treatment of obesity and has been documented to be effective and safe. This regimen facilitates compliance because of its simplicity combined with rapid weight loss, which may further encourage the patient to stick to the diet. The major drawbacks are still the patients’ complaints of hunger between meals, constipation and the infrequency of bowel movements. Recently it has been shown that fibre supplementation to a conventional diet reduces hunger, increases the frequency of bowel movements and softens the consistency of the stools. The supplementation of fibre to a formula diet designed for VLCD has not hitherto been reported.


The purpose of the present investigation was to examine if the addition of fibre to a nutrition powder improves compliance by modifying hunger, satiety, stool consistency and bowel movements. As fibre may impair intestinal absorption of various divalent cations and vitamins, we also monitored plasma levels of the most important metal ions together with other relevant plasma constituents.


Methods

To examine whether supplement of dietary fibre may improve compliance to a very low-calorie diet (VLCD) a nutrition powder (Nupo) providing 388 kcal/day (men: 466 kcal/day) was compared with a similar version containing plant fibre 30 g/day. Twenty-two obese patients entered the study. After a baseline habitual diet, they were randomized to two weeks of treatment in a single-blind design to either VLCD with or without dietary fibre. Subsequently, they were crossed over for a further 2 weeks of treatment.

Results

All 22 patients completed the study without any missed appointments or other deviations from the protocol. The two groups had similar weight losses (about 10 kg/4 weeks), and dietary fibre did not improve this result. During VLCD with fibre, hunger ratings were significantly lower than during VLCD without fibre. Bowel movements decreased from 1.9/day on a habitual diet to 0.7/day on VLCD without fibre but increased to 1.0/day by fibre supplement. No effect of fibre supplementation to satiety, consistency of faeces and flatulence. The supplement of dietary fibre did not influence plasma concentrations of divalent cations like calcium, iron or magnesium, nor did it add any lowering effect on plasma glucose, cholesterol or triglyceride to that of VLCD.

Conclusion

The supplement of dietary fibre to VLCD may improve compliance by reducing hunger and increasing the number of bowel movements, without impairment of absorption of divalent cations.


For the full study, click here.

1981-1989

Initial Very Low-Calorie Diet VLCD improves ultimate weight loss

- by Quaade, F. & Astrup, A. (1989).

Introduction

Very Low-Calorie Diet (VLCD) if it is of an adequate composition, especially with regard to protein, has long been a safe way of bringing about a considerable weight loss in obese persons within a reasonable time. We have used Nupo as a VLCD in the proper sense of the word, i.e. as the sole source of nutrition, for monthly periods. Furthermore, we use it as the mandatory base in diets of higher energy contents, usually 1000 kcal. One major reason for this is our experience that many patients do not follow a traditional diet instruction and, having done so, try to remedy this by eating less of the diet’s valuable components. Alternatively, they try to keep within the traditional diet’s overall energy frame by inserting grossly insufficient periods of total or near-total starvation. In our diets, the nutrition powder is supplemented with iso-energetic units of ordinary food and drink, each of about 63 kcal, and the portions are visualized as small pictures (“counters”) of which there are three colors: blue for items rich in protein, green for items rich in fiber, and red for sweets, fatty items, and alcoholic beverages.


As the VLCD core of the diet covers all nutritional needs, complete freedom is allowed in the patients’ choice of the 10 counters (about 630 kcal) that are allowed in the program. This regime of freedom within limits has been tested in a randomized trial and proved to reduce the dropout rate significantly. All instruction and control are done in groups, which saves resources and has obvious psychological advantages.

Methods

Thirty-eight consecutive obese persons were treated as outpatients. The treatment commenced with the VLCD formula diet Nupo (females 388 kcal, 56 g protein; males 446 kcal, 69 g protein). VLCD had no untoward effects and was continued for as long as the patient would accept. After that, the formula diet vas supplemented with ordinary items of food and drink to the level of 1000 kcal for women and 1100 kcal for men. After 5 months the data were analyzed separately according to the duration of VLCD: group 1 (n=20): VLCD for less than 2 months, and group 2 (n=18): VLCD for 2 months or more. The two groups were comparable with regard to height, absolute weight, and precentral overweight, but group 2 was somewhat older than group 1 (49,5 vs 38,3 years, P≤0.01).

Results

The weight losses of the two groups are very different. Group 1 who had given up VLCD early, lost much less weight, both in absolute and relative terms than group 2 who had more faithfully stuck to the initial VCLD regimen. The differences are significant with regard to both total weight loss and weight loss on VLCD. Group 2 lost significantly more weight, both totally (17.1 kg (7.8-40.1)) and on VLCD alone (12.3 kg (4.1-28.8)), than group 1 (8.7 kg (-1.1-19.1) and 7.3 kg (0.9-18.2). Weight losses in both groups eliminated or strongly reduced the need for a wide variety of expensive drugs: antidiabetics, diuretics, antihypertensives, analgesics, etc.

Conclusion

It is concluded that VLCD is an effective and encouraging way of starting a dieting program and that it should be continued for at least two months, as the length of the initial VLCD period related significantly to the amount of weight eventually lost.


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Formula Diet Plus Free Additional Food Choice up to 1000 Kcal (4.2 MJ) Compared with an Isoenergetic Conventional Diet in the Treatment of Obesity | A Randomised Clinical Trial

- by H. Hey, et al. (1987).

Introduction

The Formula diet NUPO meets all international recommendations for daily intakes of protein, essential amino and fatty acids, vitamins, minerals, and trace elements within a daily intake of only 388 kcal. A very low calorie (VLCD) regimen with NUPO as the sole source of nutrition for many months has caused great weight loss without risk in patients with severe obesity. If the prescribed amount of nutrition powder is taken it is justifiable to allow a free choice of additional foods, including less valuable items, as long as the energy allowance is small enough to induce weight loss. Renunciation of popular foods and beverages such as cake, sweets, wine, and spirits is one major reason why many patients do not attempt to diet or, if they do, show poor compliance.


For these reasons, we felt justified in evaluating a 1000 kcal (4.2 MJ) regimen in which a fundament of formula diet is obligatory while at the same time the patients are totally free to manage the remaining energy allowance. The control group was prescribed an isoenergetic conventional slimming diet. This group was allowed diethylpropion in self-governed moderate dosage. Another purpose of the trial was to test a recently developed dietary system based on visual symbols of iso-energetic units (counters).

Methods

86 patients aged between 18 and 59 years with more than 20% overweight were assigned to one of two slimming diets. The test group had an obligatory basis (388 kcal) of a complete formula diet (NUPO) and were allowed a totally free additional choice of food and drink up to 1000 kcal including sweets and alcohol. The control group had a conventional isoenergetic diet excluding all less valuable items (“empty calories”) but were permitted to take an anorectic drug. All patients were instructed and controlled in groups, which saved resources and had psychological advantages. In both regimens, dietary instructions were conducted within a new educational system based on isoenergetic, exchangeable units of everyday food and drink, visualized as illustrated symbols (counters).

Results

After 12 weeks, weight loss was insignificantly better on a conventional diet (8,9 kg) than in the test group (7,5 kg). By contrast, the latter group had better compliance, as evidenced by a significantly smaller dropout rate (p < 0,05). Repeated registration of energy intake showed that the consumption of “empty calories” was moderate in the test group, amounting to ab. 10% and that excess intake were primarily due to increased consumption of foods rich in fiber. Complaints of side effects were negligible in both groups. The counter diet system made instruction and control easy.

Conclusion

We conclude that a free qualitative food choice, made possible by the sufficiency of the formula diet as a basis, is a realistic, effective, and responsible alternative to conventional dietary treatment of obesity.


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Gastroplasty Preceded by Very-Low-Calorie-Diet | A Preliminary Report

- by T. Andersen, et al. (1986).

Introduction

Gastroplasty (GP) performed in morbidly obese patients is fraught with an unavoidable perioperative hazard, and weight loss is often unsatisfactory even in a short term. On the other hand, weight maintenance is better after GP than after diet alone. In order to increase the ultimate weight loss and reduce surgical hazards, consecutive patients of the present study received a mandatory two-step treatment: After initial very-low-calorie-diet, (VLCD) GP is performed provided a 40% reduction of overweight has been obtained by diet. GP patients selected in this way are equally assigned to vertical banded GP or to Gomez GP. Weight control and patient education are run at group meetings.

Methods

74 patients, all admitted for morbid obesity, have been included. Their median age was 34 years, their median body weight 125.1 kg and their median overweight 93% calculated according to a Scandinavian standard. They were all screened for contraindicating diseases through clinical examination, analyses of blood and urine, ECG and liver biopsy. Treatment was started simultaneously in about 35 patients at a time. The VLCD nutrition powder used, NUPO, is apportioned as five daily meals, and water is added as the vehicle. Between the 8-week periods with VLCD, a 2-week 900 Kcal diet consisting of natural high-protein, low-fat and low-carbohydrate foods is prescribed.


The VLCD programme is continued as long as a substantial weight loss is obtained. Anorexic agents are not allowed. Patients are offered operation as the second step of the programme only if a 2/5 reduction of overweight has been reached during VLCD. Horizontal and vertical GP are performed as published elsewhere. Weight control is run at group meetings together with a formalised patient education programme. Patients are seen weekly until three months after the operation, every second week until the 6th postoperative month and at least every three months thereafter.

Results

Results are preliminary, and no comparison can yet be made between the randomised subgroups. Median weight loss after the first eight weeks of VLCD was 17.9 kg (range, 3.6-38.4 kg, n = 74). The result of VLCD can at present be evaluated only for the treatment group first started (44 patients). Of these, 31 (70%, 95% confidence limits 55-83%) reached the limit for operation. Two patients (5% of patients otherwise available for surgery, 95% confidence limits 1-15%) failed after successful VLCD to appear for group meetings. Until now, 25 patients have had GP. Most patients have stabilised their weight 3 months after surgery. At this time median postoperative weight loss is 9.0 kg (range, 3.4-22.0 kg, n = 25) and median total weight loss from VLCD plus GP has reached 46.0 kg (range, 26.1-64.0 kg, n = 25). During VLCD, the only observed complication was one case of gout, quickly yielding to conventional treatment.

Conclusion

VLCD leads to immediate weight losses not significantly different from those obtained by GP. Compared with VLCD, GP seems to possess a long-term effect on food intake, making regain significantly less pronounced. A comparison of therapeutic hazards is in favour of VLCD, which is safe when carried out with a nutritionally adequate formula. Combining the good elements of both treatments has led to the present protocol, investigating a two-step regimen, in which GP is preceded by VLCD. After GP, compliance with diet is essential for weight reduction and safety. Pre-treatment with VLCD offers an opportunity to test patients’ ability to comply. It should be realised gastric obesity surgery will never succeed in patients not prepared to follow dietary advice. Through adjusting, the duration of VLCD weight loss can be individualised. This means that nearly all patients can reduce their overweight to less than 40%, which can be considered the lower limit of excess mortality from obesity. Preoperative weight reduction makes the operations much easier and safer and postoperative management simpler. Accordingly, patient satisfaction is improved.


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