Scientific Documents

Bimuno^TM and help to maintain a healthy gastro-intestinal function - Scientific substantiation of a health claim related to Bimuno^TM and help to maintain a healthy gastro-intestinal function pursuant to Article 13(5) of Regulation (EC) No 1924/2006 [1]

Summary (80 KB)

Opinion (132 KB)

Summary

Following an application from Clasado Limited submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Bimuno^TM and help to maintain a healthy gastro-intestinal function.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.

The food supplement, Bimuno^TM, a β-galacto-oligosaccharide mixture, which is the subject of the health claim is sufficiently characterised.

The claimed effect is “helps to maintain a healthy gastro-intestinal (GI) function by stimulating and increasing the number of bifidobacteria in the gut”. The target population is the general population from the age of 3 years upwards. From the evidence provided it has not been established that increasing the number of bifidobacteria in humans is per se beneficial to a normal GI function. The Panel considers that a normal gastro-intestinal function is beneficial to human health.

The applicant identified one double blind, placebo-controlled, crossover study in 30 healthy volunteers as being pertinent to the health claim. The subjects were randomised to receive one of the following supplements for seven days: 7 g sucrose/d, 7 g Bimuno^TM/d and 3.6 g Bimuno^TM plus 3.4 g sucrose/d (to maintain osmotic characteristics) provided in a milk powder preparation. This study was conducted with an old formulation of Bimuno^TM, 7 g corresponding to 5.5 g of the Bimuno^TM formulation which is the subject of the health claim. The primary outcome was the count of faecal bifidobacteria. The study demonstrated a bifidogenic effect of Bimuno^TM.

The applicant provided another study in patients with Rome II positive irritable bowel syndrome. The patients were randomised to receive either 3.5 g Bimuno^TM/d, 7 g Bimuno^TM/d or 7 g maltodextrin/d (placebo). This study was conducted with an old formulation of Bimuno^TM, 7 g corresponding to 5.5 g of the Bimuno^TM formulation which is the subject of the health claim.

This study supports the effects seen in other studies with respect to an increase in the number of faecal bifidobacteria after the consumption of Bimuno^TM. However, as the study was not powered adequately to detect changes in IBS symptoms, the Panel could not draw a conclusion on the effect of Bimuno^TM on any other outcome measures.

A third human randomised controlled trial used a dose of Bimuno^TM which was double the amount of Bimuno^TM proposed to obtain the claimed effect and thus it is not relevant for the substantiation of the health claim.

From in vitro and animals studies provided by the applicant, only one used Bimuno^TM. This study showed a bifidogenic effect of Bimuno^TM in vitro and in a pig model. Gut function parameters were not addressed.

The Panel considers that the studies provided by the applicant demonstrate that the consumption of Bimuno^TM, corresponding to doses between 2.75 g/d and 5.5 g/d, significantly increases the number of bifidobacteria in the gut. However, the results do not show that the changes in the number of bifidobacteria are beneficial for the gut function.

On the basis of the data presented the Panel concludes that a cause and effect relationship has not been established between the consumption of Bimuno^TM and maintenance of a normal gastro-intestinal function.