Waist circumference and reduction of appetite/hunger were highlighted as surrogate endpoints that did not, at least in the evidence presented in Gencor’s five article 13.5 dossiers, validate various weight loss claims for its herbal ingredient Slimaluma.
EFSA’s Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) had been formally criticised by Gencor and others in submitting comments to the European Commission after the opinions were delivered, but it reiterated its view that causality had not been demonstrated for either endpoint.
Reduction in waist circumference
In a letter to the European Commission’s Basil Mathioudakis, NDA unit head Dr Juliane Kleiner, said that while waist circumference correlates with the risk of cardiovascular disease in several cross-sectional and prospective cohort studies, the panel said such changes could be caused by changes in body water.
“Excess abdominal fat leads, inter alia, to insulin resistance, impaired blood glucose control and hypertriglyceridaemia, all metabolic features which cluster in the metabolic syndrome,” Dr Kleiner wrote.
“A reduction in abdominal fat generally leads to the improvement of these metabolic abnormalities and it would be, of itself, a beneficial physiological effect. However, waist circumference may also change in response to changes in body water.”
Dr Kleiner affirmed that causality had not been demonstrated between consumption of Slimaluma and a reduction in waist circumference, “leading to an improvement in adverse health effects associated with an excess abdominal fat.”
“The comments received do not change the conclusions of the Panel.”
Reduction in appetite/hunger
Similarly for the reduction of appetite and hunger endpoint, Dr Kleiner observed that it may have a beneficial physiological effect, but that this had not been adequately demonstrated.
One trial (Kuriyan et al) was criticised for unreliably reporting energy intake, failing to disclose primary outcomes, and failing to report power calculations.
The active ingredients in Slimaluma are sourced from ethanol-water extract of the aerial parts of Caralluma fimbriata.
The publications submitted in support of the claims included in vitro studies, human intervention studies and reviews on the reliability and validity of Visual Analogue Scales for the assessment of appetite, the central control of body weight and appetite, the link between leptin and obesity, the impact of soluble fibres or multivitamin and mineral supplements on body weight and mitotic clonal expansion.
Click here to read our coverage of the initial opinions and here to read how it came to be that EFSA admitted making an error in those initial opinions.