ID 807 - Laktuloza

PL: Laktuloza
EN: LACTULOSE
Pdf: lactulose

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is lactulose which is an artificial disaccharide with the chemical formula 4-O-β-D-Galactopyranosyl-β-D-fructofuranose. Lactulose can be generated by alkaline isomerisation of lactose or by enzyme-catalysed synthesis (Schuster-Wolff- Buhring et al., 2010). Lactulose is a well-characterised food constituent.
The Panel considers that the food constituent, lactulose, which is the subject of the health claims, is sufficiently characterised.

2.2. Skrócenie czasu pasażu jelitowego (ID 807)

The claimed effect is “transit effect”. 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 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.

3.2. Skrócenie czasu pasażu jelitowego (ID 807)

The references cited consisted of seven studies in human subjects. The study by Terada et al. (1992) measured the effect of lactulose on some biochemical parameters of faeces and faecal microbiota. The Panel considers that no conclusions can be drawn for the scientific substantiation of the claimed effect.
The study by Miller et al. (1997) focused on determining the impact of 10 g of lactulose or placebo with a radiolabeled test meal on orocaecal transit in eight normal human subjects. The study reported that 10 g of lactulose had a direct accelerating effect on small intestinal transit.
A double-blinded cross-over study was performed on 42 normal healthy volunteers and 24 chronically constipated subjects (Bass and Dennis, 1981). Lactulose at the dose level of 20 g or 40 g/day (in syrup form) produced clinically and statistically significant increases in the frequency, weight, volume and water content of stools in both the normal and constipated subjects. The results in normal subjects demonstrated that there was a dose-response laxative effect in both healthy normal subjects and subjects with chronic constipation.
Another study focused on the impact of lactulose on transit time and reported that lactulose at a dose of 10 g per day accelerates small bowel transit in comparison with inulin (Geboes et al., 2003). Wutzke et al. (1997) demonstrated in a study in 12 healthy volunteers that lactulose given in a dose of 10 g per day caused a small but significant effect on breath hydrogen and that this effect was associated with decreased transit time. Pontes et al. (1995) studied patients admitted to the hospital due to reasons other than constipation. These patients were administered daily 10 g of liquid or crystalline lactulose, lactitol or placebo. The treatment resulted in shorter transit times in both lactulose groups compared with the untreated controls.
Lactulose as a synthetic sugar is used in the treatment of constipation. In the colon, lactulose is broken down to lactic acid and to small amounts of acetic and formic acids by the action of beta- galactosidases from colonic bacteria. This process leads to an increase in osmotic pressure and slight acidification of the colonic content causing an increase in stool water content and softening of the stools (Drugbank, 2009).
In weighing the evidence, the Panel took into account that all studies provided showed a consistent statistically significant effect of lactulose at a dose of 10 g per day on reduction in intestinal transit time, and that the mechanism by which lactulose could exert the claimed effect is established.
The Panel concludes that a cause and effect relationship has been established between the consumption of lactulose and a reduction in intestinal transit time.

4.1. Skrócenie czasu pasażu jelitowego (ID 807)

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

5. Warunki i możliwe ograniczenia stosowania oświadczenia

The Panel considers that in order to obtain the claimed effect at least 10 g of lactulose per day should be consumed in a single serving. The target population is the general population.

Warunki i możliwe ograniczenia stosowania oświadczenia

2,5 g/day