Scientific Opinion on the substantiation of health claims related to
isomalto-oligosaccharides and maintenance of normal blood cholesterol
concentrations (ID 817) pursuant to Article 13(1) of Regulation (EC) No
1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Isomalto-oligosaccharides
blood cholesterol
health claims
1. Charakterystyka żywności / składnika
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Utrzymanie prawidłowego stężenia cholesterolu we krwi
The food constituent that is the subject of the health claim is the isomalto-oligosaccharides. Isomalto- oligosaccharides (IMO) are produced by enzymatic hydrolysis of starch and consist mainly of oligomers of isomaltose, panose, isomaltotriose, and isomaltotetraose connected by non-digestible α 1→6 glucosidic linkages. IMO do not occur naturally in foods. IMO can be quantified in foods by established methods.
The Panel considers that the food constituent, isomalto-oligosaccharides, that is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
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Utrzymanie prawidłowego stężenia cholesterolu we krwi
The claimed effect is “cholesterol maintenance”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel notes that the claimed effect relates to the maintenance of normal blood cholesterol concentrations.
The Panel considers that maintaining normal blood cholesterol concentrations is beneficial to human health.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowego stężenia cholesterolu we krwi
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Utrzymanie prawidłowego stężenia cholesterolu we krwi
Two references were presented for the substantiation of the claimed effect; both reported on human trials which investigated the effects of IMO consumption on blood lipids.
In a non-controlled, single arm intervention, seven males followed a control low-fibre diet for 30 days and were then administered 10 g/d of IMO for the next 30 days. The primary outcomes of the study were bowel function and nutritional status. No significant changes in total or HDL-cholesterol were observed during the intervention period (Chen et al., 2001).
The second study was a single-arm, non-controlled intervention conducted in 20 haemodialysis patients who consumed 30 g/d IMO for 4 weeks after a 2-week run in period (Wang et al., 2001). Statistically significant decreases in total cholesterol and triglycerides, and a statistically significant increase in high density lipoprotein-cholesterol were observed at the end of the intervention compared with the beginning. The Panel notes the small number of subjects studied the lack of a control group to account for potential confounders, and the fact that patients on haemodialysis are not representative of the general population for which the claim is intended with regards to blood lipid metabolism.
In weighing the evidence, the Panel considered the small number of subjects, the inconsistent results obtained, and the non-controlled nature of the studies presented.
The Panel concludes that a cause and effect relationship has not been established between the dietary consumption of isomalto-oligosaccharides and the maintenance of normal blood cholesterol concentrations.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, isomalto-oligosaccharides, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “cholesterol maintenance”. The target population is assumed to be the general population. Maintenance of normal blood cholesterol concentrations is beneficial to human health.
A cause and effect relationship has not been established between the consumption of isomalto- oligosaccharide and the maintenance of normal blood cholesterol concentrations.
