2252.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to formulated palm and oat oil emulsion and contribution to the maintenance or achievement of a normal body weight (ID 577) and maintenance of body weight after weight loss (ID 1553) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Palm and oat oil emulsion   body weight   health claims   weight loss  
ID:    577      1553  
Produkty: Olej palmowy, olej owsiany  

1. Charakterystyka żywności / składnika

The food constituents that are the subject of the health claims are “palm/oat oil fatty acid” and “formulated palm and oat oil emulsion”.
From the references provided, the Panel assumes that the food constituent which is the subject of the health claims is a mixture of fractionated palm oil (about 47 %) and fractionated oat oil (about 2.5 %) in a proportion 95:5 dispersed in water to give a total fat content of about 42 % (w/w). Five grams of the emulsion provide about 2 g fat. The fatty acid composition of the emulsion is known (Burns et al., 2002).
The Panel considers that the food constituent, formulated palm and oat oil emulsion, which is the subject of the health claims, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka


2.1. Udział w uzyskaniu i utrzymaniu prawidłowej masy ciała (ID 577)

The claimed effect is “weight control”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the maintenance or achievement of a normal body weight through a satiating effect.
Weight control can be interpreted as contribution to the maintenance of a normal body weight. In this context, weight loss in overweight individuals without achieving a normal body weight is considered to be a beneficial physiological effect.
The Panel considers that contribution to the maintenance or achievement of a normal body weight is a beneficial physiological effect.

2.2. Utrzymanie masy ciała po odchudzaniu (ID 1553)

The claimed effect is “weight management”. The Panel assumes that the target population is overweight individuals in the general population who wish to maintain their body weight after significant weight loss.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the maintenance of body weight after weight loss.
Maintenance of weight loss can be interpreted as contribution to the maintenance of a normal body weight after significant weight loss. In this context, the maintenance of weight loss in overweight subjects without having achieved a normal body weight is considered to be a beneficial physiological effect.
The Panel considers that maintenance of body weight after weight loss is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka

The references provided for the scientific substantiation of the claims included narrative reviews, human intervention studies and animal studies on foods/food constituents other than palm and oat oil emulsion and/or effects other than body weight (e.g. appetite and intestinal transit), and human intervention studies on the short-term effects of the food constituent on appetite ratings and energy intake (up to 36 hours). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.

3.1. Udział w uzyskaniu i utrzymaniu prawidłowej masy ciała (ID 577)

No human studies which addressed the effects of consumption of formulated palm and oat oil emulsion on body weight during weight loss were provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of formulated palm and oat oil emulsion and contribution to the maintenance or achievement of a normal body weight.

3.2. Utrzymanie masy ciała po odchudzaniu (ID 1553)

Diepvens et al. (2007) designed a randomised, placebo-controlled, double-blind and parallel intervention study to assess the effects of a formulated palm and oat oil emulsion (i.e. with the characteristics described in section 1) on body weight maintenance after weight loss. Fifty overweight or obese women (age range: 18-58 years, BMI: 25-32 kg/m2) received a very-low-energy diet (2.1 MJ/day) for six weeks (weight loss period) and then consumed a yoghurt (250 g) containing either 3 g of milk fat plus 2 g of the formulated palm and oat oil emulsion or 5 g of milk fat (control) twice daily (at breakfast and in the afternoon) for 18 weeks during which the women were asked to restore their habitual eating patterns (weight maintenance period). The composition of the intervention and control yoghurts was matched for energy (2.0 MJ/500g) and macronutrient content (carbohydrates, protein and fat = 69, 12 and 19 E%, respectively). Subjects were stratified for age, BMI, weight, height, waist, and hip circumference, and then randomised to the intervention (n=22) or control (n=28) group at the beginning of the weight loss phase. Multiple primary outcomes were identified in the study (e.g. body weight after weight loss, body composition, resting energy expenditure, and fat oxidation). However, power calculations were not reported and multiplicity of outcomes was not taken into account in the statistical analysis. Statistical significance was set at
p<0.05 for all variables. During the weight loss phase, the test and placebo groups lost 7.76 1.5 kg
and 7.65 1.4 kg, respectively. No statistically significant differences in body weight regain during the
18-month maintenance phase were observed between the intervention and placebo groups (1.13 3.4
vs. 2.95 3.1 kg, respectively, p=0.05). Weight regain as percentage of weight loss was not significantly lower in the intervention (15 %) compared to the placebo (40 %) group (p=0.055). The Panel notes that multiple primary outcomes were identified in the study, that multiplicity of outcomes was not taken into account in the statistical analysis, and that this study does not show a statistically significant effect of the food constituent on body weight maintenance after weight loss.
In weighing the evidence, the Panel took into account that the one human intervention study from which conclusions could be drawn for the scientific substantiation of the claim had some methodological limitations, and did not show a statistically significant effect of formulated palm and oat oil emulsion consumption on maintenance of body weight after weight loss.
The Panel concludes that a cause and effect relationship has not been established between the consumption of formulated palm and oat oil emulsion and maintenance of body weight after weight loss.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, formulated palm and oat oil emulsion, which is the subject of the health claims, is sufficiently characterised.
Contribution to the maintenance or achievement of a normal body weight (ID 577)
The claimed effect is “weight control”. The target population is assumed to be the general population. Contribution to the maintenance or achievement of a normal body weight is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of formulated palm and oat oil emulsion and contribution to the maintenance or achievement of a normal body weight.
Maintenance of body weight after weight loss (ID 1553)
The claimed effect is “weight management”. The target population is assumed to be overweight individuals in the general population who wish to maintain their body weight after significant weight loss. Maintenance of body weight after weight loss is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of formulated palm and oat oil emulsion and maintenance of body weight after weight loss.