– by European Food Safety Authority (EFSA) (2014)
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.
– af European Food Safety Authority (EFSA) (2017)
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 at læse hele studiet, klik her (engelsk).
– by European Food Safety Authority (EFSA) (2017)
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.
– af European Food Safety Authority (EFSA) (2010)
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 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 characterised.
To read the syudy in its entirety, click here (english)
– by European Food Safety Authority (EFSA) (2010)
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.
– by Mikkelsen, M. G. (2011).
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.
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.
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.
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.
– by T. Christiansen, et al. (2009).
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.
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.
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).
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.
– by L. Bjørn et al. (1994).
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.
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.
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.
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.
– by O. L. Svendsen, et al. (1993).
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.
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.
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.
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.
– by A. Astrup et al. (1990).
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.
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.
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.
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.
