SUBSCRIBE

Breaking News on Supplements & Nutrition - North AmericaEU edition

News > Research

Read more breaking news

 

 
Loading...

How to show a clinical trial benefit in healthy populations

1 commentBy Stephen DANIELLS , 16-Nov-2012
Last updated on 23-Jan-2013 at 01:13 GMT2013-01-23T01:13:32Z

By applying physiological stressors like partial sleep deprivation, it is possible to test the effects of dietary supplements in healthy populations and stay compliant with DSHEA, says Dr Jay Udani, CEO of Medicus Research.

Speaking with Stephen Daniells at the recent SupplySide West show in Las Vegas, Dr Udani explained his Udani Theory of Natural Health Products Clinical Trial Design.

Dr Udani breaks his theory down into three parts: First, identify healthy or at-risk population; second is to apply a physiological stressor to overwhelm their normal physiology; and third is to select end-points that are relevant not only to a scientist, but also to regulators and consumers.

“In clinical trial design, to stay compliant with DSHEA you have to have a healthy population that is not diseased,” he explained. “But if someone is so healthy, how do you actually show a benefit for your dietary supplement?”

Providing a couple of examples, Dr Udani said that boomers displaying a little slowing down in their mental processing and recall could be used as subjects in a cognitive function trial. By applying a physiological stressor like partial sleep deprivation or some kind of psychological stressor like playing a video game.

“At that point of physiological stress you start to see the difference between healthy, at-risk, and diseased. They’re clearly not diseased, but they’re hedging towards at-risk,” he said.

1 comment (Comments are now closed)

Expanding the principe

I have also been a strong supporter of the research approach of acute stress in healthy people. However, besides sleep deprivation, there are other less harsh treatments that can be used to test functions such as immunocompetence, resistance to inflammation, alertness reactions, cognitive function, eye health, and others. Some of the stressors can be induced experimentally. In some cases, one can also take advantage of circumstances that are already occurring in selected subjects.

Report abuse

Posted by Robert DiSilvestro
16 November 2012 | 19h402012-11-16T19:40:03Z

Related products

William Reed Business Media Holiday video

Happy Holidays 2014 from William Reed Business Media!

The holidays are fast upon us, so let’s put ‘business’ to one side and...

Botanical Adulterants Program 'intended to raise the bar of awareness of the problem, and I think we've done that,' Blumenthal says

Botanical Adulterants Program 'intended to raise the bar of awareness of the problem, and I think we've done that,' Blumenthal says

The Botanical Adulterants Program is “raising the bar of awareness of this growing problem among...

McGuffin: DSHEA was about preserving right to direct one's own self care

McGuffin: DSHEA was about preserving right to direct one's own self care

Michael McGuffin, president of the American Herbal Products Association, has a unique perspective on...

‘Some companies claiming they’re strengthening their defense against chondroitin adulterants are not using the right method’: Synutra President

‘Some companies claiming they’re strengthening their defense against chondroitin adulterants are not using the right method’: Synutra President

A unique collaboration of experts worked together to identify an adulterant in the chondroitin...

Israelsen: DSHEA created world's most vibrant supplement marketplace

Israelsen: DSHEA created world's most vibrant supplement marketplace

The dietary supplement business has gone from fighting for its life to enjoying the...

CRN’s Mister on DSHEA’s ‘monumental anniversary’, companies choosing a side, and the critical role of contract manufacturers for GMP complia...

CRN’s Mister on DSHEA’s ‘monumental anniversary’, companies choosing a side, and the critical role of contract manufacturers for GMP compliance

The 20th anniversary of the Dietary Supplements Health and Education Act (DSHEA) is ‘monumental’, says...

New ingredient set to give caffeine a run for its money, supplier says

New ingredient set to give caffeine a run for its money, supplier says

Ingredient supplier Compound Solutions has introduced a nature identical version of theacrine branded as...

GMPs, NDIs, and definitions for GMO and natural: NPA’s Fabricant on industry issues

GMPs, NDIs, and definitions for GMO and natural: NPA’s Fabricant on industry issues

Despite ongoing vacancies in the main office of the Division of Dietary Supplements, companies...

Cargill highlights cavity-fighting effect of Zerose erythritol at SupplySide West trade show

Cargill highlights cavity-fighting effect of Zerose erythritol at SupplySide West trade show

Research by Cargill shows its Zerose brand erythritol does more than just cut calories; ...

Adverse event reporting can provide valuable data to companies, expert says

Adverse event reporting can provide valuable data to companies, expert says

Reporting adverse events is something all dietary supplement companies must prepared to do to...

UK researcher backs supplements for omega-3 intakes

UK researcher backs supplements for boosting omega-3 intakes

Philip Calder

Professor, University of Southamption

‘You think Red Bull’s just gonna roll over? It’s not gonna happen!’

‘You think Red Bull’s just gonna roll over? It’s not gonna happen!’ Expert warns wannabes

Beverage brand development guru James Tonkin has warned wannabe entrepreneurs that going up against...

Coffee may hydrate athletes just like water: Researcher

Coffee may hydrate athletes just like water: Researcher

Sophie Killer

Doctoral researcher, Loughborough University

Caffeine in small doses and during training may boost performance

Caffeine taken during training and even in small doses may boost sports performance: Researcher

Sophie Killer

Doctoral researcher in exercise metabolism and performance nutrition

Psychobiotics can feed gut-brain health axis: 'It’s really an exciting frontier,' says professor

Psychobiotics can feed gut-brain health axis: 'It’s really an exciting frontier,' says professor

Professor John Cryan

Chair and head of the Department of Anatomy and Neuroscience,...

Algatech: Functional food on astaxanthin horizon

Algatech: Functional food on astaxanthin horizon

Israeli firm Algatechnologies will work towards gaining approval for its astaxanthin as a novel...

Fed up: Probiotic research veteran issues global call to action

Fed up: Probiotic research veteran issues global call to action

Veteran probiotic researcher professor Gregor Reid is not a happy man. It’s time the...

Industry concerned about data abuse as EFSA fans transparency wings

Industry concerned about data abuse as EFSA fans transparency wings

Euros Jones

Director of regulatory affairs, European Crop Protection Association (ECPA)

Unilever: Healthier food choices must be ‘doable’

Unilever: Healthier food choices must be ‘doable’

Hans Zevenbergen

Cross-category nutrition and health director, Unilever

Key Industry Events

 

Access all events listing

Our events, Events from partners...