Avesthagen founder Dr Villoo Patell said the company was already commissioning further studies that would involve its Teestar extract and more participants to back another article 13.5 application under the EU nutrition and health claims regulation (NHCR).
“We do not see this as a rejection,” said Dr Patell. “The outcome actually says there may well be a physiological effect of Teestar, however they need a more detailed clinical study.”
“We accept that the clinical study was carried out on a very small group of patients. We will be doing an expanded clinical study to substantiate the claim further and resubmit the documents .”
She said the new study would commence in April or May of this year.
The European Food Safety Authority's (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected the dossier as it said eight of the studies did not specifically use the Teestar extract and the one that did was underpowered and delivered inconclusive results.
The panel observed that the eight studies “were not carried out with Teestar or any other fenugreek seed extract …but rather with whole or powdered fenugreek seeds, fenugreek leaves, an extract from fenugreek leaves, fenugreek gum isolate or fenugreek composites.”
The single Teestar study was conducted with 27 male subjects who consumed Teestar (1 g) crackers or a placebo at breakfast and dinner for seven consecutive days.
Its primary endpoint was a reduction in the mean peak post-prandial blood glucose concentrations, something the NDA noted was not achieved.
However it noted, “Power calculations indicated that eight subjects per study group would yield a power of 95% to detect a difference in peak blood glucose concentrations of 0.5 mmol/L, at a significance level (two-sided) of 5% and assuming a standard deviation of 0.15 mmol/L.”
Secondary endpoints were mean blood glucose concentrations 60, 90 and 120 minutes after meals. The NDA pointed out that time points were treated as independent in the analysis, without correction for multiple comparisons.
“…no conclusions can be drawn from the secondary analysis of the study,” it stated, before concluding, “that in the absence of evidence for an effect of Teestar on post-prandial glycaemic responses in humans, animal studies on potential mechanisms do not provide support for the scientific substantiation of the claim.”
The target population was “healthy adults with or without impaired glycaemic pre-obese and obese conditions.”
The NDA opinion can be found here.
The EFSA opinion comes despite a recent meta-analysis that found in favour of fenugreek and its glycaemic response potential.
Scientists from the National University of Singapore, McMaster University (Canada), and Harvard University concluded medium and high doses (at least 5 grams per day) of fenugreek seed powder were associated with significant reductions in fasting blood glucose levels in diabetics.
“Our systematic review and meta-analysis suggest that fenugreek seeds may contribute to better glycemic control in persons with diabetes mellitus with a similar magnitude of effect as intensive lifestyle or other pharmaceutical treatment added to standard treatment,” they wrote in the Nutrition Journal .
“Fenugreek is widely available at low cost and generally accepted in resource poor countries such as India and China where a large proportion of persons with diabetes in the world reside. Therefore, fenugreek may be a promising complementary option for the clinical management of diabetes.”