ID 784 -
Polidekstroza
PL: Polidekstroza
EN: Polydextrose
Pdf: polydextrose
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is polydextrose.
Polydextrose is produced by the poly-condensation of glucose in the presence of sorbitol and citric acid under vacuum at high temperatures (Radosta et al., 1992). Polydextrose is highly branched, with a degree of polymerisation between 2 and 110 (on average approximately 12 glucose units), and with an average molecular weight of ~2,000 Daltons (Allingham, 1982; Murray, 1988). All possible linkages with the glycosidic carbon of glucose are present: α- and β-1,2; 1,3; 1,4; and 1,6; with the 1,6 linkage predominating (Auerbach et al., 2007). Polydextrose is highly soluble in water (80 g/100 g at 25°C) leading to a low viscosity solution (Allingham, 1982; Auerbach et al., 2007). Besides the polymer, polydextrose consists of small amounts of the starting materials glucose, sorbitol and citric acid, as well as levoglucosan and hydroxymethylfurfural formed by caramelisation during the poly- condensation process. Owing to the complex linkage distribution in the highly branched structure, it has been stated that polydextrose is resistant to gastric acid and mammalian gastro-intestinal enzymes (Auerbach et al., 2006). Polydextrose is used primarily in the food industry as a stabiliser, thickening agent, humectant and carrier (E1200).
The Panel considers that the food constituent, polydextrose, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effects.
2.1. Zmiany w funkcjonowaniu jelit (skrócenie czasu pasażu jelitowego, zwiększenie częstości ruchów jelit, zwiększenie objętości stolca) (ID 784)
The claimed effect is “improves the bowel function”. The Panel assumes that the target population is the general population.
The Panel notes that the claimed effect refers 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.
2.2. Zmiana produkcji krótkołańcuchowych kwasów tłuszczowych (SCFA) i/lub odczynu pH w przewodzie pokarmowym (ID 784)
The claimed effect is “improves the bowel function”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to changes in short chain fatty acid (SCFA) production and/or pH in the gastro-intestinal tract.
The Panel considers that changes in SCFA production and/or pH in the gastro-intestinal tract are not beneficial physiological effects per se, 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 polydextrose and a beneficial physiological effect related to changes in SCFA production and/or pH in the gastro-intestinal tract.
2.4. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 784)
The claimed effect is “improves the bowel function”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effect refers to reducing gastro-intestinal discomfort.
The Panel considers that reduction of gastro-intestinal discomfort is a beneficial physiological effect.
3.1. Zmiany w funkcjonowaniu jelit (skrócenie czasu pasażu jelitowego, zwiększenie częstości ruchów jelit, zwiększenie objętości stolca) (ID 784)
The references provided for the scientific substantiation of the claim included textbooks and general reviews which did not provide original data for the scientific substantiation of the claim. The majority of human, animal and in vitro studies were unrelated to the food constituent which is the subject of the health claim, and/or were unrelated to the claimed effect. Studies which were unrelated to the claimed effect included references on the effect of polydextrose consumption on blood lipids, intestinal
microbiota and glucose absorption, and on the energy value of polydextrose. One paper was in Japanese and a translation into an EU language was not available to the Panel. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
In four of the human intervention studies provided, the effect of polydextrose consumption on bowel function was evaluated.
In a randomised, placebo-controlled, double-blind parallel study, the effect of polydextrose (0, 4, 8 or 12 g/day given for 28 days) added to the usual diet on faecal frequency and faecal wet and dry weight in 120 healthy volunteers (66 men and 54 women; 30 subjects per group) was investigated (Zhong et al., 2000). The Dunnett’s multiple pair-wise comparison test was used to assess differences between the polydextrose groups and the placebo group. The Panel notes that the study has several weaknesses: the substance used as placebo was not specified, compliance to the diet during the intervention was not reported, and no details about randomisation or blinding were given. In addition, the main outcome of the study was not specified, no information about power calculations was provided, and multiplicity of outcome measures was not adequately taken into consideration in the statistical analyses. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
Endo et al. (1991), in a sequential non-randomised intervention study, evaluated faecal weight in eight healthy volunteers (six male) given a low cholesterol diet, a high cholesterol diet, and a high cholesterol diet supplemented with polydextrose (15 g/day) consecutively for two weeks each. The Panel notes that the order of the interventions was not randomised, and notes the lack of information about the methods used for statistical analysis. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
Tomlin and Read (1988) assessed the effect of polydextrose consumed in addition to the usual diet on transit time, stool mass, stool frequency and stool consistency in a group of 12 healthy male volunteers in a randomised, single-blind, three arm cross-over study. After a 10 day run-in period, subjects received 30 g/day of polydextrose, 7 g/day of psyllium, and a mixture of polydextrose and psyllium (30 and 2 g/day, respectively) for 10 days each with a one week wash-out period in between. The statistical significance of differences between periods was tested by the Wilcoxon's matched-pairs signed ranks test. The Panel notes that the study was not adequately controlled, and that the dose of polydextrose used was several times higher than in the proposed conditions of use. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
The effect of “acute” polydextrose ingestion (days 9-16, 30 g/day) and “chronic” polydextrose ingestion (days 17-38, 30 g/day) compared to the “control” period without polydextrose consumption (days 1-8, 0 g/day) on gastro-intestinal transit time and faecal weight was evaluated by Achour et al. (1994) in a non-randomised sequential study in seven male volunteers on a controlled diet. The Panel considers that no conclusions can be drawn from this uncontrolled study for the scientific substantiation of the claim.
The Panel notes that no human studies have been provided from which conclusions could be drawn for the scientific substantiation of the claim. The Panel considers that evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of polydextrose consumption on changes in bowel function in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of polydextrose and changes in bowel function.
3.3. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 784)
The references described in section 3.1 were also provided in relation to this claimed effect.
No human studies were provided which addressed outcomes related to gastro-intestinal discomfort.
The Panel concludes that a cause and effect relationship has not been established between the consumption of polydextrose and reduction of gastro-intestinal discomfort.
Warunki i możliwe ograniczenia stosowania oświadczenia
4g/ day