1801.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to isomalto-oligosaccharides and reduction of post-prandial glycaemic responses (ID 798), and increase in the frequency of daily bowel movements (ID 800) 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: Isomalto-oligosaccharides   blood glucose   bowel function   glycaemic responses   health claims  
ID:    798      800  
Produkty: Izomaltooligosacharydy  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is 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, which is the subject of the health claims, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka


2.1. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 798)

The claimed effect is “low glycaemic index”. The Panel assumes that the target population is individuals willing to reduce their post-prandial glycaemic responses.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to the reduction of post-prandial glycaemic responses.
Postprandial glycaemia is interpreted as the elevation of blood glucose concentrations after consumption of a food and/or meal. This is a normal physiological response that varies in magnitude and duration and may be influenced by the chemical and physical nature of the food or meal consumed, as well as by individual factors (Venn and Green, 2007). The evidence provided does not establish that decreasing post-prandial glycaemic responses in subjects with normal glucose tolerance is a beneficial physiological effect. However, it may be beneficial to subjects with impaired glucose tolerance as long as post-prandial insulinaemic responses are not disproportionally increased. Impaired glucose tolerance is common in the general population of adults.
The Panel considers that reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased) may be a beneficial physiological effect.

2.2. Zwiększenie częstości codziennych wypróżnień (ID 800)

The claimed effects are “normal bowel function/gastrointestinal function/colonic function”. The Panel assumes that the target population is individuals with constipation.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect is related to an increase in the frequency of daily bowel movements.
The Panel considers that an increase in the frequency of daily bowel movements within the normal range might be a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka


3.1. Zmniejszenie stężenia glukozy we krwi po posiłku (ID 798)

Two references were provided for the scientific substantiation of this claim. One was in Chinese and unavailable to the Panel, and the second reported on an intervention study in dogs on post-prandial glucose concentrations (Hesta et al., 2001). The Panel considers that while effects shown in animal studies may be used as supportive evidence, human studies are required for the substantiation of a claim, and that the evidence provided in animal studies alone is not sufficient to predict the occurrence of an effect of isomalto-oligosaccharides consumption on the reduction of post-prandial glycaemic responses in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of isomalto-oligosaccharides and reduction of post-prandial glycaemic responses.

3.2. Zwiększenie częstości codziennych wypróżnień (ID 800)

The information provided consisted of two references which reported on human intervention studies.
In a non-controlled, single arm, intervention seven elderly males followed a control low-fibre diet for 30 days and were then administered 10 g/d of IMO for the next 30 days (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). The Panel notes the small number of subjects studied and the lack of a control group. The Panel considers that no conclusions can be drawn from these uncontrolled studies for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of isomalto-oligosaccharides and an increase in the frequency of daily bowel movements.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, isomalto-oligosaccharides, which is the subject of the health claims, is sufficiently characterised.
Reduction of post-prandial glycaemic responses (ID 798)
The claimed effect is “low glycaemic index”. The target population is assumed to be individuals willing to reduce their post-prandial glycaemic responses. The reduction of post- prandial glycaemic responses may be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of isomalto-oligosaccharides and reduction of post-prandial glycaemic responses.
Increase in the frequency of daily bowel movements (ID 800)
The claimed effect is “increase the frequency of daily bowel movements”. The target population is assumed to be individuals with constipation. An increase in the frequency of daily bowel movements within the normal range might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of isomalto-oligosaccharides and an increase in the frequency of daily bowel movements.