ID 2931 -
Częściowo hydrolizowana guma guar
PL: Częściowo hydrolizowana guma guar
EN: Partially Hydrolysed Guar Gum (PHGG)
Pdf: partially hydrolysed guar gum
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is partially hydrolysed guar gum (PHGG).
PHGG is produced from guar gum by digestion with D-mannanase. It has a low viscosity and a molecular weight of about 20 kDa. PHGG is not naturally occurring in foods, and is usually consumed in the form of food supplements. PHGG can be measured in foods by established methods.
The Panel considers that the food constituent, partially hydrolysed guar gum, which is the subject of the health claims, is sufficiently characterised.
2.3. Zmiany w funkcjonowaniu jelit (skrócenie czasu pasażu jelitowego, zwiększenie częstości ruchów jelit, zwiększenie objętości stolca) (ID 813, 853, 1902, 1903, 1904, 2929, 2930, 2931)
The claimed effects are “improved intestinal conditions (pH, SCFA production) and intestinal functions”, “bowel function”, and “intestinal health and regularity”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, 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 that these changes do not result in diarrhoea.
2.4. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 813, 1902, 1903, 1904, 2929, 2930, 2931)
The claimed effects are “improved intestinal conditions (pH, SCFA production) and intestinal function” and “intestinal health and regularity”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the reduction of gastro-intestinal discomfort.
The Panel considers that reduction of gastro-intestinal discomfort is a beneficial physiological effect.
3.2. Zmiany w funkcjonowaniu jelit (skrócenie czasu pasażu jelitowego, zwiększenie częstości ruchów jelit, zwiększenie objętości stolca) (ID 813, 853, 1902, 1903, 1904, 2929, 2930, 2931)
Among the references provided for the scientific substantiation of the claim were textbooks and narrative reviews which did not contain any original data for the scientific substantiation of the claim. Some human studies were not related to the food constituent which is the subject of the claim, examined the effect of PHGG in combination with other substances, or addressed health outcomes (e.g. prevention and treatment of diarrhoea) other than the claimed effect. One reference was not accessible to the Panel after every reasonable effort to retrieve it had been made. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Five human intervention studies addressed the effects of PHGG on intestinal transit time/frequency of defecations.
Four of the human studies provided were one-arm, uncontrolled, open label studies which evaluated the effects of PHGG supplementation on different measures of bowel function (Giaccari et al., 2001; Patrick et al., 1998; Takahashi et al., 1993; Takahashi et al., 1994). The Panel notes that these studies were uncontrolled, and considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
A randomised, controlled, cross-over study by Meier et al. (1993) reported on the effects of a standardised diet and two liquid formula diets, with and without supplementation of PHGG (21 g/L), on oro-caecal and colonic transit time in 12 healthy male volunteers. The diets were consumed in a randomised order for seven days each. PHGG did not significantly affect oro-caecal transit time. Colonic transit time, however, was significantly prolonged (55 hours) with the liquid diet containing PHGG compared to the liquid diet without PHGG (39 hours), and to the normal diet (30 hours) (p<0.01). Stool frequency and consistency were not significantly affected by PHGG supplementation. The Panel notes that this study does not show a significant effect of PHGG on stool frequency or consistency, and that PHGG increased rather than decreased colonic transit time.
In weighing the evidence, the Panel took into account that the only human intervention study provided from which conclusions could be drawn for the scientific substantiation of the claim did not show any effect of PHGG on stool frequency or consistency, and that PHGG induced an increase rather than a decrease in colonic transit time.
The Panel concludes that a cause and effect relationship has not been established between the consumption of partially hydrolysed guar gum and changes in bowel function.
3.3. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 813, 1902, 1903, 1904, 2929, 2930, 2931)
A number of the references provided in relation to the claim were textbooks and narrative reviews which did not provide any original data for the scientific substantiation of the claim. Some human studies were not related to the food constituent which is the subject of the claim, examined the effect of PHGG in combination with other substances, or addressed outcomes (e.g. measures of bowel function, and prevention and treatment of diarrhoea) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Four human intervention studies which addressed gastro-intestinal discomfort, were provided.
One of the human studies was a one-arm, open label, uncontrolled study on the effects of PHGG (5 g/day for 24 weeks) on frequency of defecation and intensity of symptoms in patients with irritable
bowel syndrome (IBS) (Giaccari et al., 2001). The Panel considers that no conclusions can be drawn from this uncontrolled study for the scientific substantiation of the claim.
In a randomised, not placebo-controlled, open label study, Parisi et al. (2005) assessed the effects of PHGG supplementation on gastro-intestinal symptoms and quality of life in IBS patients, who were randomly assigned to consume 60 mL of an apple-flavoured beverage providing either 10 g/day (n=40) or 5 g/day (n=46) of PHGG for 12 weeks. The Panel considers that no conclusions can be drawn from this uncontrolled study for the scientific substantiation of the claim.
In a multicentre, randomised, open label study, Parisi et al. (2002) investigated the effect of PHGG (5 g/day) compared to wheat bran (30 g/day) on gastro-intestinal symptoms in 188 IBS patients. After four weeks, patients were allowed to voluntarily change intervention, depending on their subjective evaluation of symptoms. The severity of abdominal pain was assessed in a semi-structured interview designed for the purpose of the study, and the overall effect of the intervention was assessed by asking the subjects whether IBS symptoms were worse, unchanged or better compared to baseline. No information on the validity of this method was given. The Panel notes that this study was not blinded, and that no information was given about the validity of the methods used for assessing the effect of the intervention. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
In a parallel study in 40 patients with constipation predominant IBS (28 females, mean age 54 years), Uneddu et al. (2005) assessed the effect of consuming 10 g/day of PHGG compared to 100 g of bread (made of 70 % hard wheat flour, bran and refined bran, consisting in a total of 10.4 g of fibre on average) for 60 days. The frequency and intensity of abdominal symptoms were assessed by a 4-point Likert scale questionnaire. No information about the validity of the questionnaire used was given. The Panel notes that the intervention was not blinded, and that successful blinding of subjects is particularly important when evaluating self-reported health outcomes for which a high placebo effect can be expected. The Panel considers that no conclusions can be drawn from this unblinded study, which used a non-validated questionnaire for abdominal symptom assessment, 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 partially hydrolysed guar gum consumption on a decrease in potentially pathogenic gastro-intestinal microorganisms in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of partially hydrolysed guar gum and reduction of gastro-intestinal discomfort.
Warunki i możliwe ograniczenia stosowania oświadczenia
7 – 36 g/day or more
