ID 775 - 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.

2.2. Zmienia produkcję krótkołańcuchowych kwasów tłuszczowych (SCFA) i odczyn pH w przewodzie pokarmowym (ID 775)

The claimed effect is “improved intestinal conditions (pH, SCFA production) and intestinal functions”. The Panel assumes that the target population is the general population.
The Panel notes that the claimed effect refers to changes in short chain fatty acid (SCFA) production and pH in the gastro-intestinal tract.
The Panel considers that changes in SCFA production and pH in the gastro-intestinal tract are not per se beneficial physiological effects, but need to be linked to a beneficial physiological or clinical outcome. No evidence has been provided to indicate the context in which the claimed effect could be considered as a beneficial physiological effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of fructooligosaccharides from sucrose and a beneficial physiological effect related to changes in SCFA production and pH in the gastro-intestinal tract.

2.3. Zmiany w funkcjach jelita (ID 775, 778)

The claimed effects are “improved intestinal conditions (pH, SCFA production) and intestinal functions”, and “gastrointestinal conditions and functions”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effects refer to changes in bowel function.
The Panel considers that changes in bowel function such as reduced transit time, more frequent bowel movements, increased faecal bulk, or softer stools may be a beneficial physiological effect, provided these changes do not result in diarrhoea.

2.4. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 775, 778)

The claimed effects are “improved intestinal conditions (pH, SCFA production) and intestinal functions”, and “gastrointestinal conditions and functions”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effects refer to reducing gastro-intestinal discomfort.
The Panel considers that reduction of gastro-intestinal discomfort is a beneficial physiological effect.

3.2. Zmiany w funkcjach jelita (ID 775, 778)

Among the references provided were reviews, textbooks and opinions from authoritative bodies which either did not address the claimed effect or did not contain any original data which could be used for the scientific substantiation of the claimed effect. A number of human studies addressed the effects of substances other than FOS or of a mixture of FOS with other substances, or addressed outcomes not related to the claimed effect (e.g. abdominal comfort). The provided animal and in vitro studies assessed endpoints not related to the claimed effect (e.g. butyrate content in faeces, SCFA content, number of selected microbiota, β-galactosidase, α-glucosidase, β-glucosidase and β-glucuronidase activity, colon crypts depth, numbers of epithelial and mitotic cells in the crypt columns, caecal wall weight, proliferation index and indices of artificially provoked colitis). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Bouhnik et al. (1996) found, in a randomised, placebo-controlled study in a group of healthy volunteers (n=20) with saccharose as placebo, that FOS consumption of 12.5 g/day did not significantly affect stool weight (FOS group: 134±22 g/day, placebo group: 121±19 g/day, p>0.05).
In a randomised, single-blind, parallel trial FOS (mean dose 0.74±0.39 g/day) was added to cereal formula intended for feeding infants and given for 28 days to a group of healthy term infants (n=27) aged 4–12 months (mean 8.3 months) (Moore et al., 2003). The effect of FOS addition to cereals was compared to the same cereals with the addition of the equivalent amount of maltodextrin (n=29). Stool frequency was recorded by parents. The Panel notes that the tool used for assessing bowel function (parent's assessment) was not validated, that the main aim of the study was to assess tolerance of FOS given to infants, and that the sample size was relatively small. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
In a single-blind study, Tokunaga et al. (1993) studied the effect of FOS (daily dose 1.3 or 5 g) on intestinal microbiota and bowel function in 27 healthy volunteers. The Panel notes that the study was not placebo-controlled, that no information about randomisation was given, and that multiple comparison testing was not included in the statistical analysis. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
In weighing the evidence, the Panel took into account that the only relevant human study showed no effect of FOS consumption on bowel function.
The Panel concludes that a cause and effect relationship has not been established between the consumption of fructooligosaccharides from sucrose and changes in bowel function.

3.3. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 775, 778)

All references considered in section 3.2. were also provided for the substantiation of this claim.
A number of human studies addressed the effects of substances other than FOS or of a mixture of FOS with other substances, or addressed outcomes not related to the claimed effect (e.g. stool frequency and intestinal microbiota). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
S) from sucrose related health claims
11 EFSA Journal 2010;9(4):2023
Only one human study addressed the effect of FOS from sucrose on abdominal comfort.
Paineau et al. (2008) evaluated in a randomised, multicentre, double-blind, placebo-controlled study the effect of FOS from sucrose (5 g/day) vs. placebo (sucrose and maltodextrins) on the digestive comfort of subjects with minor functional bowel disorders (n=105, mean age 38 years, 85 % women). The prevalence and general frequency of digestive symptoms based on Rome II criteria were recorded in a questionnaire including questions about the presence and intensity of five abdominal symptoms (discomfort or pain; fullness, bloating or swelling; feeling of incomplete bowel movement; urgency; straining at stool). This questionnaire (called the initial questionnaire) was used for inclusion, and at the end of the study to determine changes in intensity of symptoms. The participants were also asked to complete a questionnaire (called the consultation questionnaire) designed to assess the frequency of digestive symptoms and stool quality before the intervention period and at the end of the study. Quality of life was assessed using the French language functional digestive disorders quality of life questionnaire (FDDQL). Baseline intensity of symptoms at the beginning of the study was similar in both studied groups. The participants took two packets daily containing 2.5 g FOS or placebo for six weeks. Eight subjects dropped out during the study (four in each group) and compliance was estimated as good for 50 subjects (24 in FOS and 26 in placebo group). Final results were presented only for these 50 subjects. The Panel notes that except for the quality of life questionnaire no information was provided on the validation of the other questionnaires, that the validated quality of life questionnaire alone is insufficient as an outcome measure, that a power calculation was not presented, that only the data obtained from 48 % of the participants included in the study were used for statistical analysis of the results, that no intention-to-treat analysis of the data was reported, and that in the statistical analysis correction for multiple testing was not performed. The Panel considers that no conclusions can be drawn from this study 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 fructooligosaccharides from sucrose and reduction of gastro-intestinal discomfort.

Warunki i możliwe ograniczenia stosowania oświadczenia

5g/ day