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Dispatches from FIE 2011

Clinical trial design in the new EU health claims regime: “Now we have to work on the borderline”

By Shane Starling from Paris , 19-Dec-2011
Last updated on 20-Dec-2011 at 12:27 GMT

How to demonstrate health benefits among healthy human beings? That is the challenge new European Union health claim laws have set contract research organisations (CROs) and others involved in trial design. A tough challenge yes, but not an insurmountable one, say two of Europe’s leading experts in the area.

“It was easier before,” Jeorg Gruenwald, PhD, the president and co-founder of German-based consultancy and CRO, analyze&realize told a NutraIngredients round-table.

“I have been doing clinical trials for about 25 years now. Lots in botanicals, lots in food products. In good, earlier times we could really high cholesterol values, really [high] blood pressure and show how natural products worked. Now we have to work on the borderline.”

Measuring healthy outcomes in the healthy

Roberta Re, PhD, nutrition research manager at Leatherhead Food Research, emphasised the importance of demonstrating benefits in healthy populations.

“While in the past you would try and see the effect of a product on a specific health outcome you could use more extreme or manifested physiological issues either if it was cholesterol or diabetes or so forth; now we have to be much more careful about how we select our health studies,” she said.

“Therefore there is a new healthy group of people with either a risk or a minor incident of a health problem that we have to target and we have to be able to shown an improvement that is not really a disease. So it really is not an easy challenge.”

Crossing the borderline

Gruenwald highlighted advances made in areas like weight management and immunity where official European Food Safety Authority (EFSA) guidance was proving useful.

Re observed the gap that exists between much nutrition research that has been performed by academia and the highly specific demands being made of the discipline under the 2006 EU nutrition and health claims regulation (NHCR).

“It is therefore understanding how you are using the available science to substantiate a claim for a dossier,” she said.

Gruenwald agreed that there was much about the NHCR’s demands that could not be fulfilled by the current body of academic work alone.

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