SUBSCRIBE

Breaking News on Supplements & Nutrition - EuropeUS edition

Read more breaking news

 

 
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 GMT2011-12-20T12:27:24Z

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

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.

Related products

Food manufacturers must encourage healthy choices

Food manufacturers’ role in delivering ‘a fitter future’

Food and drink manufacturers must do more to encourage consumers to make healthy choices...

Upcoming EU sports nutrition law revamp – a win for industry?

Upcoming EU sports nutrition law revamp – a win for industry?

Craig Simpson

EU food law expert , Steptoe & Johnson

Smart combinations: Juices blend fruit and vegetable ingredients for nutritional punch and flavor appeal

Smart combinations: Juices blend fruit and vegetable ingredients for nutritional punch and flavor appeal

Vegetable ingredients may boost the nutritional content of beverages: but when it comes to...

Refreshment and nutrition drive demand for vegetable ingredients

Refreshment and nutrition drive demand for vegetable ingredients

Vegetable ingredients are winning favor with consumers who value them as a healthy part...

Marketing to the ‘elderly'

Marketing to the ‘elderly’: Overcoming the taboo of getting old

There is a need for public health strategies and products to address Europe's rapidly...

The 4 biggest mistakes in healthy marketing

The 4 biggest mistakes in healthy marketing

The Healthy Marketing Team tells us what NOT to do when marketing a healthy...

Top snacking trends

Top snacking trends revealed as UK leads innovation

Health and indulgence are key trends shaping the snack market as the UK leads...

Protein could give endurance athletes an extra edge, says Arla Foods

Protein could give products for endurance athletes an extra edge, says Arla Foods Ingredients

A new fast absorbing protein from Arla Foods Ingredients could help crack open the...

IPA chief: "Regulators are starting to turn the corner on probiotics"

IPA chief: "Regulators are starting to turn the corner on probiotics"

A new-look International Probiotics Association is creating dialogue with key regulators around the world,...

FiE 2015: Our best bits

FiE 2015: Our best bits

Our teams of journalists were out in force at Food Ingredients Europe (FiE) last...

New tech on EFSA’s horizon: Crowdsourcing and cyber assistants

New tech on EFSA’s horizon: Crowdsourcing and cyber assistants

New technology like crowdsourcing and artificial intelligence computers is the future of risk assessment,...

EFSA’s Bernhard Url: Science should reserve one private room for open debate

EFSA’s Bernhard Url: Science should reserve one private room for open debate

Since taking the European Food Safety Authority (EFSA) throne last summer, Dr Bernhard Url has become...

Seadragon sets out to breathe fire into Kiwi fish oil

Seadragon sets out to breathe fire into Kiwi fish oil

The town of Nelson will welcome New Zealand's first omega-3 fish oil processing plant...

The taste test: How do you make a probiotic drink taste good?

The taste test: How do you make a probiotic drink taste good?

Probiotic fruit drinks face different challenges to their dairy counterparts - but both face...

African probiotic project reaching 10,000 infants a day

African probiotic project reaching 10,000 infants a day

Professor Gregor Reid

Chair , University of Western Ontario & Human Microbiology and...

Germvangelist set to shake Probiota with holistic shout

Germvangelist set to shake Probiota with holistic shout

Jason Tetro

Researcher, author, The Germ Guy

Creepy proteins will be hot

New proteins are creeping on trend

Alternative proteins are a “hot area” of interest and products such as sandwich spreads...

Dairy ingredients giant on Indonesia: ‘A lot of opportunities here’

Dairy ingredients giant on Indonesia: ‘A lot of opportunities here’

Jake Riddle

General manager, Kerry Asia Pacific

Indonesia stakes claim as SE Asia's most important food market

Indonesia stakes claim as SE Asia's most important food market

Indonesia's food industry will continue to grow in importance as its population of around...