ID 805 - Fruktooligosacharydy z sacharozy

PL: Fruktooligosacharydy z sacharozy
EN: Fructoligosaccharides from sucrose
Pdf: fructooligosaccharides

Oświadczenie (2)

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