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
 
	
	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.