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EFSA health claim opinion

EFSA on Valio peptide claim: “No convincing evidence for a mechanism”

By Shane Starling , 03-Oct-2011
Last updated on 03-Oct-2011 at 14:29 GMT

The European Food Safety Authority (EFSA) has rejected a peptide-blood pressure health claim submitted by Finnish dairy group, Valio, saying the dossier containing 21 intervention studies failed to demonstrate an effect.

“…there is no convincing evidence for a mechanism by which IPP and VPP [the peptides] could exert the claimed effect at the proposed dose,” EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found of the article 13.5 emerging and proprietary science submission.

The rejection follows a summer dismissal of an 86-study strong immunity dossier for Valio’s probiotic strain Lactobacillus rhamnosis GG (LGG) that is used in its popular 20-year-old functional drink, Gefilus.

For the peptide claim, the NDA said that while many of the 21 intervention studies showed a beneficial effect on blood pressure, trial design issues discounted most of the data for the two forms of peptide in question: isoleucyl-prolyl-proline (IPP) and valyl-prolyl-proline (VPP).

“…eight reported an effect of IPP and VPP on office systolic blood pressure (SBP) of which seven, however, showed major methodological limitations related to treatment allocation, randomisation, blinding and statistical analyses,” the NDA found.

“Of these trials, four also reported an effect of IPP and VPP on office diastolic blood pressure (DPB). The remaining 13 RCTs, of which four were designed to detect small (3 5 mm Hg) differences in SBP, did not observe an effect of IPP and VPP on SBP or DBP.”

Valio declined to comment on the NDA opinion which can be found here.

The Nordic firm proposed the claim: “Peptides IPP and VPP help to maintain normal blood pressure.”

Detail

The Panel discounted a meta analysis due to study quality variation and dismissed animal data as irrelevant.

“…the Panel considers that the meta-analyses do not provide information in addition to the individual studies considered pertinent to the claim by the applicant.”

Ex vivo and in vitro studies linking IPP and VPP production from casein digestion, which highlighted a potential mechanism of action via angiotensin converting enzymes (ACE 1 and ACE 2) inhibition, were also dismissed as non-significant.

The NDA concluded: “In weighing the evidence, the Panel took into account that 13 of the human intervention studies provided, four of which were adequately powered to detect small between-group differences in SBP, did not observe an effect of IPP and VPP on SBP or DBP; that the interpretation of the results from seven out of the eight studies which reported an effect of IPP and VPP on office SBP was hampered by major methodological limitations; that the animal studies did not provide additional information on the effect of IPP and VPP on BP in humans; and that there is no convincing evidence for a mechanism by which IPP and VPP could exert the claimed effect at the proposed dose.”

Other opinions

EFSA's health claims panel also accepted a claim from DSM linking vitamin D consumption and reduced risk of falling in over-60 year-olds.

It rejected a claim from French slimming product company,Ceprodi KOT, that its slimming foods, "could reduce adipocyte size at the abdominal level".

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