ID 839 - Błonnik z otrębów pszennych

PL: Błonnik z otrębów pszennych
EN: TRITICUM SATIVUM-WHEAT BRAN-WHEAT
Pdf: wheat bran fibre

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is “wheat grain fibre”, “wheat bran and wheat bran products”, and “Triticum aestivum – wheat bran”. The Panel assumes that the active food constituent is wheat bran fibre.
Wheat bran fibre is a component of wheat bran, which consists of the outer coat (pericarp, testa and aleuron layer) of the wheat grain (Triticum aestivum L). Wheat bran is separated from the other parts of the wheat kernel by milling and the chemical composition of wheat bran varies with the extraction rate. Wheat bran is predominantly composed of non-starch polysaccharides (∼38 %), starch (∼19 %), protein (∼18 %) and lignin (∼6 %), with the non-starch polysaccharides being primarily ∼70 % arabinoxylans, ∼19 % cellulose and ∼6 % β-(1,3)/β-(1,4)-glucan. Wheat bran typically contains approximately 45 % of dietary fibre, of which about 95 % is non-soluble fibre (Cornell and Hoveling, 1998; Pomeranz, 1988). Wheat bran products may differ with regard to chemical composition and particle size depending on the milling process.
The Panel considers that the food constituent, wheat bran fibre, which is the subject of the health claims, is sufficiently characterised.

2.2. Skrócenie czasu pasażu jelitowego (ID 828, 839, 3067, 4699)

The claimed effects are “gut health” and “intestinal transit time, intestinal health”. 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 a reduction in intestinal transit time.
The Panel considers that a reduction in intestinal transit time within the normal range might be a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 

Forty seven studies were cited for the scientific substantiation of two claimed effects: “increase in faecal bulk” and “reduction in intestinal transit time”.
Several studies were considered as not being pertinent for the scientific substantiation of the claimed effects evaluated in sections 3.1 and 3.2: a study with patients with severe constipation following spinal cord injury (Cameron et al., 1996), a study measuring the effect of wheat bran on faecal bile acid concentration (Alberts et al., 1996) and publications targeted for the general public (Medical News Today; Mindell, 1994). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effects. The data from two references were identical (Fuchs et al., 1976; Floch and Fuchs, 1978) and were treated as one study. The text of the unpublished study was not available to the Panel (Dodi, unpublished).

3.2. Skrócenie czasu pasażu jelitowego (ID 828, 839, 3067, 4699)

In 23 human intervention studies the effect of wheat bran fibre on intestinal transit time was evaluated.
The studies differed by design (randomised controlled trials, single or double-blind, cross-over design, non-randomised). Different doses of wheat bran fibre were used and the dose used was expressed in different ways (e.g. dose of wheat bran, dose of fibre given or administered, portion of food enriched by wheat bran); different methods were used to assess transit time (several radio-opaque markers and scintigraphic methods) and different methods were applied to calculate the results (e.g. mean transit time, time needed to pass 50 %, 75 % or 80 % of pellets, number of pellets in first two stools passed at least 24 h after ingestion of the marker, percent of pellets in faeces within three days after marker intake). Taking into account the different designs of the studies presented, it is not possible to compare all of these results directly.
From the 23 studies provided, the results of 14 studies (with the dose of wheat bran fibre from 4 to 27 g daily) demonstrated a statistically significant decrease of intestinal transit time (Arffmann et al.,1985; Badiali et al., 1995; Cummings et al.,1976; Graham et al., 1982; Lampe et al., 1993; Lewis and Heaton, 1997; Melcher et al., 1991; Mortensen et al., 1987; Muir et al., 2004; Rees et al., 2005; Spiller et al., 1986; Stephen et al., 1986; Stevens et al., 1988; Tomlin and Read, 1988). In three studies, administration of wheat bran (with the dose of fibre from 6 to 8 g daily) did not significantly affect transit time (Eastwood et al., 1973, 1983; Vincent et al., 1995). The remaining six studies measured multiple endpoints and their results were not consistent (Ziegenhagen et al.; 1991; Balasubramanian et al., 1987; Hebden et al., 2002; Wrick et al., 1983; Wyman et al., 1976; Smith et al., 1981).
A meta-analysis of 20 cross-over studies (with wheat bran fibre 5–18 g/day) demonstrated an effect of wheat bran fibre on decreasing intestinal transit time but the dose effect was not assessed (Muller- Lissner, 1988).
The amount of at least 10 g/day of wheat bran fibre was connected with a statistically significant decrease in intestinal transit time in 14 out of 16 studies submitted. In another two studies, only some of the methods used for assessing intestinal transit time showed an effect (Wrick et al. 1983; Ziegenhagen et al., 1991).
The results of nine studies in which wheat bran fibre was used at the daily dose of 4-9.9 g revealed inconsistent results. In four studies a decrease in intestinal transit time was found (Spiller et al., 1986; Muir et al., 2004; Rees et al., 2005; Graham et al. 1982) while in another three studies, no effect on transit time could be demonstrated (Eastwood et al., 1973, 1983; Vincent et al., 1995). In the remaining two studies, intestinal transit time was measured by several methods and only the results of part of the measurements showed a statistically significant effect (Wyman et al., 1976; Smith et al., 1981).
The Panel notes the dose-dependency of the results and that trials with daily doses of wheat bran fibre below 10 g resulted in inconsistent outcomes.
Wheat bran fibre increases water holding capacity of the content of the intestine, increases intestinal and pancreatic fluid secretion and thus increases the velocity of chyme displacement through the intestine (Jenkins et al., 1987).
In weighing the evidence, the Panel took into account that the studies provided consistently indicated that wheat bran fibre consumed at an amount of at least 10 g/day decreased intestinal transit time.
The Panel concludes that a cause and effect relationship has been established between the consumption of wheat bran fibre and a reduction in intestinal transit time.

4.2. Skrócenie czasu pasażu jelitowego (ID 828, 839, 3067, 4699)

The Panel considers that the following wording reflects the scientific evidence: “Wheat bran fibre contributes to a reduction in intestinal transit time”.

5.2. Skrócenie czasu pasażu jelitowego (ID 828, 839, 3067, 4699)

The Panel considers that in order to obtain the claimed effect at least 10 g per day of wheat bran fibre should be consumed in one or more servings. The target population is the general population.

Warunki i możliwe ograniczenia stosowania oświadczenia

1) Contains at least 25g wheat bran per portion. 2) 8g dietary fibre from wheat bran per portion compliance measure.