EFSA rejects Stablor fat reduction health claim

By Eliot Beer

- Last updated on GMT

EFSA rejects Stablor fat reduction health claim

Related tags: Nutrition, Obesity, Metabolism, Efsa

French firm LNC has failed in its bid to gain an approved health claim for its medical weight loss drink Stablor, with EFSA critiquing one human clinical trial, and rejecting LNC’s other evidence.

Laboratoires Nutrition et Cardiometabolisme (LNC) applied for a health claim last year,​ with the wording “In the context of a well-balanced diet and a mild caloric restriction, the addition of Stablor contributes to decrease visceral fat while preserving lean mass in overweight or obese subjects with abdominal fat and cardiometabolic risk factors​”.

Stablor is a drink powder containing a mix of proteins, vitamins and minerals, with a patented mixture of tryptophan and neutral amino acids.

According to the applicant, Stablor works to counteract and normalise different metabolic disorders linked to excessive visceral fat, particularly dysregulation of the [tryptophan] metabolism and disturbances in the protein metabolism​,” wrote the EFSA panel in their opinion.

Three of four studies rejected

LNC submitted four human studies as evidence to EFSA, but the panel rejected three of them for not including control groups.

EFSA accepted the design of a fourth study, completed in 2014 – but found problems with the results. Upon examination of the data, EFSA noted the per-protocol (PP) analysis was much more favourable to Stablor, with a P-value of 0.02, compared to the full analysis set (FAS), with a P-value of 0.06, below significance.

When asked to explain the differences between the analyses, LNC told the EFSA panel that five patients in the Stablor group and three in the control group had been excluded for “major protocol violation” – including poor compliance, ingestion of excluded drugs, and several subjects who did not meet inclusion criteria, but were incorrectly included.

Subject exclusion shifted results

The Panel notes that the exclusion of the three non-compliant subjects from the analysis had a big impact on the results, particularly by decreasing the amount of visceral fat mass loss in the control group​,” the EFSA panel wrote.

The Panel considers that this study does not show an effect of Stablor on the primary outcome in the primary (FAS) analysis and that the PP analysis for the primary outcome is at risk of bias​,” they added.

As a result, the EFSA panel rejected the health claim, saying a cause-and-effect relationship between the consumption of Stablor and a reduction in visceral fat had not been established.

When asked to comment on EFSA’s opinion, or future plans for Stablor, LNC CEO Jean-Luc Treillou declined to comment.

Source: EFSA Journal
Published online ahead of print, doi: 10.2903/j.efsa.2017.4723
Scientific Opinion on the Stablor® and reduction of visceral fat while maintaining lean mass: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006​”
Authors: Turck D, Bresson J-L, Burlingame B, et al

Related topics: Regulation & Policy

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