ID 805 -
	
		
			Fruktooligosacharydy z sacharozy
		
		
		
	 
PL: Fruktooligosacharydy z sacharozy
EN: Fructoligosaccharides from sucrose
Pdf: fructooligosaccharides
 
        
        
                
1. Charakterystyka żywności / składnika
                
                
                    The food constituent that is the subject of the health claim is fructooligosaccharides obtained from  sucrose.  
Fructooligosaccharides (FOS) obtained from sucrose are prepared by enzymatic elongation of sucrose,  and consist of a mixture of kestose (glucose-fructose-fructose, GF2), nystose (GF3) and  fructosylnystose (GF4), with an average degree of polymerisation (DPav) of 3.6, and are sometimes  referred to as short-chain fructooligosaccharides. They differ from natural fructans by degree of  polymerisation (DP) (only 10 % of native chicory inulins have a DP between 2 and 5) (Roberfroid,  2007), and from oligofructoses prepared by inulin hydrolysis (DP from 2 to 7, DPav 4) by the  systematic presence of a glucose moiety.  
The Panel considers that the food constituent, fructooligosaccharides (FOS) from sucrose, which is the  subject of the health claims, is sufficiently characterised.  
                 
                 
	        
        
        
        
        
                
2.6. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 805)
                
                
                    The claimed effect is “blood lipids”. 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 of normal blood LDL-cholesterol concentrations.  
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the  arteries. Elevated LDL-cholesterol, by convention >160 mg/dL (>4.1 mmol/L), may compromise the  normal structure and function of the arteries.  
The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial  physiological effect.  
                 
                 
	        
        
        
        
                
2.7. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 805)
                
                
                    The claimed effect is “blood lipids”. The Panel assumes that the target population is the general  population.  
In the context of the references provided, the Panel assumes that the claimed effect refers to the  maintenance of normal (fasting) blood concentrations of triglycerides.  
Triglycerides in plasma are either derived from dietary fats or synthesised in the body from other  energy sources like carbohydrates. In fasting conditions, serum triglycerides are mainly transported in  very-low-density lipoproteins (VLDL) synthesised in the liver. Hormones regulate the release of  triglycerides from adipose tissue in order to meet energy needs between meals. Normal values for  blood concentrations of triglycerides have been defined.   
The Panel considers that maintenance of normal (fasting) blood concentrations of triglycerides may be  a beneficial physiological effect.  
                 
                 
	        
        
        
        
        
                
3.5. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 805)
                
                
                    Among the references cited in relation to this claim were general reviews on “prebiotic” substances,  references addressing outcomes either not related to the claimed effect or using different  oligosaccharides or polysaccharides than FOS from sucrose, which is the subject of the claim, and a  meta-analysis on the effects of fructans on triglyceride concentrations in humans. The Panel considers  that no conclusions can be drawn from these references for the scientific substantiation of the claimed  effect.  
A total of eight human studies addressed the effects of FOS from sucrose on blood cholesterol  concentrations (Alles et al., 1999; Daubioul et al., 2005; Giacco et al., 2004; Hidaka et al., 1991; Luo  et al., 1996; 2000; van Dokkum et al., 1999; Yamashita et al., 1984).  
In the 2-week study by Yamashita et al. (1984), no direct comparison between the intervention  (18 diabetic subjects consuming 8 g/day of FOS from sucrose) and control (10 subjects consuming  5 g/day of sucrose) groups with respect to changes in total and LDL-cholesterol concentrations was  reported. The Panel considers that no conclusions can be drawn from this study for the scientific  substantiation of the claimed effect.  
In the randomised, controlled intervention by Hidaka et al. (1991), 46 hyperlipidaemic patients  (20 men, 26 women) received either 8 g/day of FOS from sucrose or the same amount of sucrose  (control) for five weeks. Total cholesterol concentrations were significantly decreased in the  intervention group compared to placebo. In a second experiment reported in the same publication,  seven hypercholesterolaemic subjects with type II hyperlipoproteinaemia received 8 g/day of FOS  from sucrose for one month. This intervention was not controlled (one arm). The Panel considers that  no conclusions can be drawn from the second experiment for the scientific substantiation of the  claimed effect.  
In the remaining six studies, 8-20 g/day of FOS from sucrose were consumed by 7-30 subjects  (healthy or with type 2 diabetes) during two to eight weeks, using either a double-blind, randomised 
S) from sucrose related health claims  
13 EFSA Journal 2010;9(4):2023  
controlled design or a cross-over design. These studies (91 subjects in total, including 24 healthy,  30 mildly hypercholesterolaemic, 30 with type 2 diabetes, and seven with non alcoholic liver steatosis)  reported no significant differences on total blood cholesterol concentrations or cholesterol sub- fractions between the FOS and the control groups (Alles et al., 1999; Daubioul et al., 2005; Giacco et  al., 2004; Luo et al., 1996; 2000; van Dokkum et al., 1999).    
In weighing the evidence, the Panel took into account that six out of the seven small intervention  studies from which conclusions could be drawn for the scientific substantiation of the claim did not  observe a significant effect of FOS from sucrose on blood cholesterol concentrations.   
The Panel concludes that a cause and effect relationship has not been established between the  consumption of fructooligosaccharides from sucrose and maintenance of normal blood  LDL-cholesterol concentrations.   
                 
                 
	        
        
        
        
                
3.6. Utrzymanie prawidłowego stężenia cholesterolu we krwi na czczo (ID 805)
                
                
                    All references considered in section 3.5. were also provided for the substantiation of this claim.  
A meta-analysis of randomised clinical trials on the effects of inulin-type fructans and FOS from  sucrose on plasma concentrations of triglycerides (Brighenti, 2007) was provided. No separate  conclusions on the effects of inulin-type fructans and FOS from sucrose were presented, and hence no  conclusions can be drawn from this meta-analysis for the scientific substantiation of the claimed  effect.   
In addition, eight human intervention studies which addressed the effects of FOS from sucrose on  blood concentrations of triglycerides were provided (Alles et al., 1999; Daubioul et al., 2005; Giacco  et al., 2004; Hidaka et al., 1991; Luo et al., 1996; 2000; van Dokkum et al., 1999; Yamashita et al.,  1984).  
In the two-week study by Yamashita et al. (1984), no direct comparison between the intervention  (18 diabetic subjects consuming 8 g/day of FOS from sucrose) and control (10 subjects consuming  5 g/day of sucrose as placebo) groups with respect to changes in blood concentrations of triglycerides  was reported. The Panel considers that no conclusions can be drawn from this study for the scientific  substantiation of the claimed effect.  
The remaining seven publications reported on randomised, controlled trials with either parallel or  cross-over designs, in which 8-20 g/day of FOS from sucrose were consumed by 7-30 subjects during  two to eight weeks. None of these studies (181 subjects in total, including 24 healthy, 120 mildly  hypercholesterolaemic, 30 with type 2 diabetes, and seven with non alcoholic liver steatosis) reported  statistically significant differences on blood concentrations of triglycerides between the FOS and the  control group (Alles et al., 1999; Daubioul et al., 2005; Giacco et al., 2004; Hidaka et al., 1991; Luo et  al., 1996; 2000; van Dokkum et al., 1999).  
In weighing the evidence, the Panel took into account that none of the seven intervention studies from  which conclusions could be drawn for the scientific substantiation of the claim observed a significant  effect of FOS from sucrose on blood concentrations of triglycerides.   
The Panel concludes that a cause and effect relationship has not been established between the  consumption of fructooligosaccharides from sucrose and the maintenance of normal (fasting) blood  concentrations of triglycerides. 
S) from sucrose related health claims  
14 EFSA Journal 2010;9(4):2023  
                 
                 
	        
        
Warunki i możliwe ograniczenia stosowania oświadczenia
Minimum of 8g/day