ID 1410 - 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).

2.1. Redukcja masy ciała (ID 1410)

The claimed effect is “safe and effective weight loss, long term weight maintenance”. The Panel assumes that the target population is obese adults who wish to reduce their body weight.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to a reduction in body weight.
Weight loss can be interpreted as the achievement of a normal body weight in previously obese subjects. In this context, weight loss in obese subjects without the achievement of a normal body weight is considered a beneficial physiological effect.
The Panel considers that reduction in body weight is a beneficial physiological effect.

3.1. Redukcja masy ciała (ID 1410)

The references provided for the scientific substantiation of the claim included abstracts with insufficient information for a scientific evaluation, narrative reviews, and human intervention studies on diets other than VLCDs (e.g. low carbohydrate diets and low fat diets) and/or effects other than body weight changes (e.g. body composition and snoring). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Four reviews (Ayyad and Andersen, 2000; Jebb and Goldberg, 1998; Miura et al., 1989; Mustajoki and Pekkarinen, 2001) and two meta-analyses (Anderson et al., 2004; Gilden Tsai and Wadden, 2006) including most of the original human intervention studies presented on the effects of VLCDs on body weight loss were provided.
The two meta-analyses were based on 19 individual studies including more than 2,500 overweight or obese subjects (the majority of whom were obese) of both sexes (the majority of whom were females) treated with VLCDs for between eight and 28 weeks (median 22 weeks), and with a follow-up period of between one and five years.
The meta-analysis by Anderson et al. (2004) was based on 47 intervention studies conducted in obese but otherwise healthy adult subjects (BMI at least 30 kg/m2 at baseline) which assessed the effects of meal replacements (at least two meal replacements per day, four studies), energy restricted diets (providing >1,500 kcal per day, six studies), low-energy diets (providing 800-1500 kcal per day, 10 studies), VLCDs (providing up to 800 kcal per day, 19 studies), and soy diets (providing up to 800 kcal per day, eight studies), and reported weight loss data after 24 weeks of treatment. Participants in the 19 studies on VLCDs were 1,968 obese subjects of both sexes with an average initial BMI of 39.6 kg/m2 (range 36.1 to 41.9 kg/m2). The mean drop-out rate in these studies was 35.3 %. Data were reported for 1,347 women and 396 men. Subjects lost an average of 22.6 % of their initial body weight over the 24 weeks of intervention; such weight loss was significantly higher than the weight loss achieved with any other weight loss strategy considered, and this significant difference with respect to other weight loss strategies was maintained after one year. However, no significant differences in body weight loss were observed between weight loss strategies at longer follow-ups. Subjects on VLCDs maintained an average weight loss of 16.1 %, 9.7 %, 7.8 %, 7.0 % and 6.2 % of their initial body weight at follow-up after one, two, three, four and five years, respectively. Large individual differences were observed in long-term effectiveness depending on the initial amount of weight loss, additional (behavioural) interventions, and level of physical activity. VLCDs and low-energy-diet programs were the weight loss strategies which required more aggregated medical visits, clinic visits and class hours (e.g. intensity score about four times higher than meal replacements). The Panel notes that the majority of studies presented data on completers only, and not on the intention-to-treat population.
The meta-analysis by Gilden Tsai and Wadden (2006) included only randomised controlled trials (RCTs) comparing the efficacy of low calorie diets (LCDs) vs. VLCDs, and which included follow-up data of at least one year after maximum weight loss. Six RCTs including 233 subjects met the inclusion criteria. Initial VLCD treatment for 8-12 weeks followed by an LCD containing 1,000 to 1,600 kcal/day and behavioural treatment for additional 12 to 104 weeks was compared to LCD and behavioural treatment of similar durations. Maximal weight loss for subjects in the VLCD group ranged between 13.4 and 19.9 % of initial body weight, which was approximately 6.5 % more than that observed for subjects in the LCD group. Body weight at 1.5-2 years of follow-up in the VLCD group was -12.3 to -7.6 % of initial body weight, which was slightly but still significantly (1.5 % difference) lower than in the LCD group.
The remaining references and reviews, which addressed the effects of VLCDs on weight loss compared to other dietary strategies aimed at weight loss, are in agreement with these two meta-analyses. Compared with other non-surgical interventions for weight loss, VLCDs in the context of intense supervision (e.g. by physicians and other health professionals) lead to greater weight loss (ranging from 12 to 20 % of initial body weight or about 12 to 35 kg) after 8-16 weeks of treatment, although considerable weight regain occurs when follow-up is extended for a number of years, particularly in the absence of behavioural modifications at follow-up. However, about one third of women and about 28 % of men still had 10 % lower body weight after five years. Those subjects had generally been more successful during the weight loss phase (Jebb and Goldberg, 1998; Mustajoki and Pekkarinen, 2001; Pekkarinen et al., 1996).
Although VLCDs appear to be superior in producing large initial weight loss compared with other dietary interventions, long-term success is highly dependent on additional interventions including long-term life-style changes and active follow-up (Ayyad and Andersen, 2000). Miura et al. (1989) assessed the effects of combining VLCDs and behavioural modifications vs. the effects of either VLCD alone or behavioural modification alone in 70 obese subjects refractory to other weight loss interventions. VLCD alone or in combination with behavioural modifications showed no significant
differences in initial weight loss (7.5 2.1 vs. 8.3 2.3 kg/month). However, after 2 years, the group on
VLCD only had regained on average 4.3 3.5 kg (>50% of their initial weight loss) while the group receiving the combination of VLCD plus behavioural modification had lost one additional kg
(-1.0 0.7 kg) and the group on behavioural therapy only had lost an additional 1.3 2.2 kg. Compared to the group receiving behavioural therapy only, the total weight loss at two years was not significantly different in the group on VLCD only (approximately -5 kg in both groups).
In weighing the evidence, the Panel took into account that the evidence provided consistently showed a greater reduction of body weight in obese subjects on VLCDs compared to other dietary interventions aimed at weight loss.
The Panel concludes that a cause and effect relationship has been established between the consumption of a VLCD and reduction in body weight.

4.1. Redukcja masy ciała (ID 1410)

The Panel considers that the following wording reflects the scientific evidence: “Replacing the usual diet with a very low calorie diet helps to lose weight”.

5.1. Redukcja masy ciała (ID 1410)

The Panel considers that in order to bear the claim, a diet should comply with the specifications and conditions of use laid down in CODEX STAN 203-1995. The target population is obese adults who wish to reduce their body weight.

Warunki i możliwe ograniczenia stosowania oświadczenia

Nutritionally complete formula VLCD providing <800 kcal/day