ID 1412 - Dieta o bardzo niskiej zawartości energii

PL: Dieta o bardzo niskiej zawartości energii
EN: Very low calorie diet (VLCD) Programme
Pdf: very low calorie diets

1. Charakterystyka żywności / składnika

The diet that is the subject of the claims is "very low calorie diet (VLCD) program".
Very low calorie diets (VLCDs) or very low energy diets are diets which contain energy levels between 450 and 800 kcal per day, and 100 % of the recommended daily intakes for vitamins and minerals. They should contain not less than 50 g of high-quality protein (protein-digestibility-corrected amino acid score of 1), should provide not less than 3 g of linoleic acid and not less than 0.5 g alpha-linolenic acid with a linoleic acid/alpha-linolenic acid ratio between 5 and 15, and should provide not less than 50 g of available carbohydrates (CODEX STAN 203-19956). VLCDs are typically used for 8-16 weeks.
The Panel notes that the nutritional composition and use of VLCDs is not regulated in the European Union.
Additional components or interventions included in a "very low calorie diet (VLCD) program", however, are not sufficiently characterised; these may vary between programs and may affect both initial weight loss and long term weight maintenance. Similarly, the types of available carbohydrates (e.g. their chemical composition and physical properties) which formula foods for use in VLCDs should contain, are not specified. The Panel also notes that the fatty acid composition of formula foods for use in VLCDs is only partially specified (CODEX STAN 203-1995).
The Panel considers that whereas the diet which is the subject of the claim, VLCD, is sufficiently characterised in relation to the following claimed effects: reduction in body weight (ID 1410), reduction in the sense of hunger (ID 1411), and reduction in body fat mass while maintaining lean body mass (ID 1412), VLCD is not sufficiently characterised in relation to: reduction of post-prandial glycaemic responses (ID 1414) and maintenance of normal blood lipid profile (ID 1421), mainly owing to the lack of standardisation of the type of available carbohydrates and of most of the fatty acids that formula foods for use in VLCDs should contain.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of a VLCD and reduction of post-prandial glycaemic responses (ID 1414) and maintenance of normal blood lipid profile (ID 1421).
The Panel considers that the diet which is the subject of the claim, VLCD, is sufficiently characterised in relation to the following claimed effects: reduction in body weight (ID 1410), reduction in the sense of hunger (ID 1411) and reduction in body fat mass while maintaining lean body mass (ID 1412).

2.3. Redukcja tkanki tłuszczowej z utrzymaniem beztłuszczowej masy ciała (ID 1412)

The claimed effect is “burning fat for energy, preserving lean tissue”. The Panel assumes that the target population is obese adults in the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the loss of fat mass while maintaining lean body mass during weight loss.
The Panel considers that reduction in body fat mass while maintaining lean body mass is a beneficial physiological effect.

3.3. Redukcja tkanki tłuszczowej z utrzymaniem beztłuszczowej masy ciała (ID 1412)

The references provided for the scientific substantiation of the claim included narrative reviews, and human intervention studies on the effects of diets other than VLCDs (e.g. low carbohydrate diets, and low fat diets) on body composition. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Ryttig and Rossner (1995) assessed body composition changes in 60 obese subjects on a diet providing 330 kcal/day for 12 weeks using tetra polar bioelectrical impedance analysis. The Panel
notes that this diet does not comply with the minimum requirement of 450 kcal/day for VLCDs, and considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
Zahouani et al. (2003) reported on a study in 1,389 obese subjects who lost on average 10.3 5.5 kg fat
mass and 2.2 2.05 kg fat free mass after 90 days on a VLCD. Body composition was assessed by leg-to-leg bioelectrical impedance analysis. Burgess (1991) found that fat mass contributed 75 % to total weight loss after 12 weeks of VLCD treatment assessed by hydro-densitometry as well as by bio-impedance analysis in 17 obese subjects (9 women). Coxon et al. (1989) randomised obese females to consume either a VLCD providing 405 kcal/day (n=12) or a VLCD providing 800 kcal/day (n=14) for eight weeks, each aimed at obtaining different rates of weight loss. Body composition was assessed by bioelectrical impedance analysis and by infrared interactance. A ratio of just over 0.4 between loss of fat free mass and total weight loss regardless of the rate of weight loss was observed. Hoie et al. (1993) assessed the quality of weight loss by near-infra-red interactance in 127 obese subjects on a VLCD for eight weeks. Mean weight reduction was 12.7 kg (12.6 % of initial weight) and mean body fat loss was 9.5 kg, which constitutes about 75 % of the weight loss. Mean reduction in lean body mass was 3.2 kg. No correlation was found between initial body mass index (BMI) and loss of lean body mass, or between initial body composition and weight loss. Morgan et al. (1992) assessed changes in body composition using total body nitrogen measured by in vivo neutron activation analysis in 11 females on a VLCD for 11 weeks. The mean loss of total body nitrogen was 125±57 g, equivalent to 781±356 g protein. The fat-free mass component of the weight loss was calculated by two different methods as 23.5 % (±3 % SEM) and 22.8 % (±2.7 % SEM), respectively.
The Panel notes that none of the studies provided assessed the effects of VLCDs on body composition compared to other dietary strategies for weight loss, that most of the studies provided used bioelectrical impedance analysis or infrared interactance for body composition analysis, both of which are not considered as reliable methods to assess changes in body composition in obese subjects during rapid weight loss, and that in most of the studies provided body fat accounted for about 70-78 %, and fat-free mass for about 22-30 %, of the total weight lost, which is, respectively, the approximate composition of the excess body weight in obese subjects and the approximate composition of the weight loss which could be expected by the use of other weight loss strategies.
In weighing the evidence, the Panel took into account that the evidence provided did not consistently show a greater reduction in body fat mass relative to lean body mass in obese subjects on VLCDs compared to other dietary interventions aimed at weight loss.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a VLCD and reduction in body fat mass while maintaining lean body mass.

Warunki i możliwe ograniczenia stosowania oświadczenia

Nutritionally complete very low calorie diet formula providing <800kcal/day