Scientific Opinion on the substantiation of health claims related to
phaseolamine and reduction in body weight (ID 1701) 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:
Phaseolamine
body weight
health claims
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim is phaseolamine.
Phaseolamine is a generic name for a proteinaceous inhibitor of animal alpha-amylases that is obtained from kidney beans (Phaseolus vulgaris L.) and which can be purified to homogeneity by conventional protein fractionation methods (Marshall and Lauda, 1975). Different extracts standardised by their in vitro alpha-amylase inhibitory activity exist on the market.
The Panel considers that the food constituent, phaseolamine, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect.
2. Znaczenie oświadczenia dla zdrowia człowieka
The claimed effect is “inhibit α-amylase activity, hindering the conversion of complex carbohydrate to simple sugars, which are stored as reservoir fats if not immediately utilised by the organism; it results in a lower calories intake, contributing to weight loss”. The Panel assumes that the target population is overweight individuals in the general population who wish to reduce their body weight.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to reduction in body weight.
Weight loss can be interpreted as the achievement of a normal body weight in previously overweight subjects. In this context, weight loss in overweight subjects without the achievement of a normal body weight is considered to be a beneficial physiological effect.
The Panel considers that reduction in body weight is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Redukcja masy ciała
The references provided for the scientific substantiation of the claim included human studies which reported on health outcomes unrelated to the claimed effect (e.g post-prandial blood glucose
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responses), and a study on the extraction process and purification of phaseolamine. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
An open label, one arm human intervention study which investigated the effects of consuming a food supplement containing 750 mg phaseolamine per capsule (three capsules twice daily) for eight weeks on body weight in 10 overweight subjects was provided (Koike et al., 2005). The Panel considers that no conclusions can be drawn from this uncontrolled study for the scientific substantiation of the claim.
In a randomised, placebo-controlled, human intervention study (Udani et al., 2004), 39 obese subjects (4 males, age range 20-69 years) were randomly allocated to consume 1,500 mg of a water extract from Phaseolus vulgaris L. (phaseolamine, n=20) or placebo (n=19) twice daily at lunch or dinner for eight weeks in the context of a “low-fat/high fibre” diet providing 100-200 g of complex carbohydrates mainly at the main meals. A total of 27 subjects completed the study. Data analysis was intention-to-treat. Body weight was assessed at weeks 2, 4, 6 and 8 of the study. No significant differences in body weight changes between groups were observed during the study at any time point. The Panel notes that consumption of phaseolamine did not lead to a significant reduction in body weight compared to placebo in this study.
In a second randomised, placebo-controlled, human intervention study (Celleno et al., 2007), 60 overweight subjects were randomly allocated to consume an 800 mg tablet containing 445 mg of a dried water extract from Phaseolus vulgaris L. (phaseolamine) standardised to a minimum of 3,000 alpha-amylase inhibiting units (n=30) or placebo (microcrystalline cellulose and maltodextrin, n=30) once daily before the main, carbohydrate-rich, meal for 30 days, after a two-week run-in phase in which all subjects received placebo. Dietary recommendations were provided to all subjects, and these recommendations included a daily intake of complex carbohydrates concentrated in one or two meals. The study diet provided 2000-2200 kcal/day. A total of 59 subjects (29 controls) completed the study and entered data analysis. A significant reduction in body weight was observed in the
intervention group (-2.93 1.16 kg) compared to placebo (-0.35 0.38 kg, p<0.001). The Panel notes the short duration of the study.
In vitro studies which investigated the effects of phaseolamine on amylase activity and starch digestion were also provided. The Panel considers that evidence provided in in vitro studies is not sufficient to predict an effect of phaesolamine on starch ingestion in vivo in humans.
In weighing the evidence, the Panel took into account that although one short-term (30 day) intervention study in humans showed an effect of phaseolamine consumption on reduction in body weight, a second human intervention study using higher phaseolamine doses and of longer duration (eight weeks), did not show an effect of phaseolamine consumption on body weight changes at any time point considered.
The Panel concludes that a cause and effect relationship has not been established between the consumption of phaseolamine and reduction in body weight.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, phaseolamine, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect.
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The claimed effect is “inhibit α-amylase activity, hindering the conversion of complex carbohydrate to simple sugars, which are stored as reservoir fats if not immediately utilized by the organism; it results in a lower calories intake, contributing to weight loss”. The target population is assumed to be overweight individuals in the general population who wish to reduce their body weight. Reduction in body weight is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of phaseolamine and reduction in body weight.
