Clinical Trial

PLMI 2014 Thought Leaders Consortium

Strategic product development for a personalized, practitioner-driven approach to cardiovascular, metabolic, and cognitive health

17-Dec-2014 By Barry W. Ritz, PhD, VP Scientific and Regulatory Affairs, Atrium Innovations Inc

Developing innovative dietary supplement products for nutrition-trained or functional medicine practitioners who engage in a personalized approach to patient management presents interesting challenges and opportunities. How do you develop, manufacture...

Medicus says its mobile platform proving ability to deliver faster, better, cheaper studies

25-Nov-2014 By Hank Schultz

Medicus Research has passed a milestone with the announcement of its 20th clinical trial using smartphone technology to enroll subjects and collect data.  The technology continues to prove its robustness and cost effectiveness, said Medicus CEO Jay Udani...

Team approach called for in designing cogent product research strategy

20-Nov-2014 By Hank Schultz

In designing a clinical trial strategy its important to keep end points in mind—and it’s not just avoiding disease endpoints we’re talking here. It’s vital to end up with information that can aid in the marketing of the product, experts say.

Polyphenol blend shows metabolic and ‘quality of life’ improvements

23-Sep-2014

Daily supplementation with a blend of polyphenol-rich extracts from grapefruit, grape, green tea, guarana and black carrot may boost metabolic functions, says a new study using Fytexia’s Fiit-ns branded ingredient.

Ullman on Bayer-FTC issue: ‘Be as careful with your implied claims & testimonials as you are with the express claims’

17-Sep-2014 By Stephen Daniells

The US Federal Trade Commission’s motion against Bayer for claims made for its probiotic dietary supplement, Phillips’ Colon Health “warrants close monitoring” because of the potential wide-ranging implications, according to a prominent attorney.

Bayer ‘extremely disappointed & strongly disagrees’ with FTC/DoJ allegations against Phillips’ Colon Health claims

12-Sep-2014 By Stephen Daniells

Healthcare giant Bayer has said it will defend itself ‘vigorously’ against the US Federal Trade Commission decision to bring a motion against the company for claims made for its probiotic dietary supplement, Phillips’ Colon Health.

Transparent lines of responsibility critical to support reliability of studies, experts say

11-Sep-2014 By Hank Schultz

Having more than one research organization involved in a study is not necessarily uncommon, but having clearly defined roles so that the integrity of the data remains intact and the results can be trusted is crucial, experts say.  

Special edition: Outsourcing

Mobile technology and RCTs: An innovative trend on the rise

12-May-2014 By Stephen DANIELLS

Smart phones are enhancing the way CROs run clinical trials, but what's possible with mobile technology, how is the technology affecting recruitment and compliance, and how do you measure success?  

Largest ever human clinical study using tocotrienols for neuroprotection

Vitamin E tocotrienols show brain health benefits

14-Apr-2014 By Stephen DANIELLS

Daily supplements of a natural full spectrum palm mixed tocotrienol complex may protect against the progression of white matter lesions in human brains, says a new study from Malaysia and the UK.

Chromadex CEO: ‘We think Niagen has a much bigger market, like omega-3’

26-Mar-2014 By Stephen DANIELLS

The potential of nicotinamide riboside, the next generation vitamin B3, goes beyond dietary supplements, into functional food and beverages, medical foods, infant nutrition and more, says the CEO of Chromadex.

BioGaia confirms extended agreement with Nestlé for clinical research and NPD

13-Mar-2014 By Nathan Gray

Swedish probiotic player BioGaia has broadened and strengthened its ties with food manufacturing giant Nestlé by agreeing a deal for clinical research and new product development (NPD), according to the firm.

Naturex gets Canadian NPN number for green coffee bean extract benefits

28-Feb-2014

The Canadian Natural Health Product Directorate (NHPD) has granted a Natural Product Number (NPN) for Naturex’s Svetol green coffee bean extract for its benefits on weight management and cardiovascular health.

Vegetarian diet could slash blood pressure: Meta-analysis

25-Feb-2014

Consuming a vegetarian diet may be associated with lower blood pressure, and as such could be used to reduce blood pressure and heart disease risk, say researchers.

‘Significant’: Vitamin E may slow functional decline in moderate Alzheimer patients

02-Jan-2014 By Stephen DANIELLS

Daily supplements of vitamin E (alpha tocopherol) may slow functional decline in people with mild to moderate Alzheimer’s disease, say results of a double-blind, placebo-controlled, parallel-group, randomized clinical trial.

PL Thomas becomes PLT Health Solutions to reflect evolution as strategic supplier

12-Nov-2013 By Stephen DANIELLS

The 60-year evolution of PL Thomas from a representative firm to distributor and now as a strategic supplier of ingredient solutions is being marked with the company renaming itself as PLT Health Solutions.

Novel keratin ingredient may relieve joint pain and stiffness: RCT data

17-Sep-2013 By Stephen Daniells

Daily intake of a keratin-based dietary supplement may provide relief for the symptoms of knee osteoarthritis, suggest results of a clinical trial published in the Journal of Dietary Supplements.

Health Canada grants two probiotic health claims for Pharmax

17-May-2013 By Stephen DANIELLS

Health Canada is at it again – the Federal Canadian health department has granted more health claims for probiotics, with Pharmax, a Seroyal brand offering a comprehensive line of professional-grade, evidence-based nutraceuticals, receiving two approvals.

Research elucidates different approaches to modern ashwagandha ingredients

15-Apr-2013 By Hank Schultz

Ashwagandha, sometimes called the “king” of ayurvedic herbs, has been gaining traction in the North American marketplace.  A big part of the reason is the investments in clinical science and the marketing support made by major suppliers of the ingredient,...

Carnitine researcher recognized with award

26-Mar-2013

Supplement industry pioneer Dr Stephen L. DeFelice has been honored with the 2013 Marconi Science award by UNICO, the largest Italian-American service organization at a recent meeting of the organization in Las Vegas.

News in brief

Horphag named American Botanical Council's Tyler Award recipient

25-Feb-2013 By Stephen DANIELLS

The American Botanical Council has announced Pycnogenol producer Horphag Research as the recipient of its annual Varro E. Tyler Commercial Investment in Phytomedicinal Research Award.

USANA chooses science over speed, official says

29-Nov-2012 By Hank Schultz

USANA Health Sciences has taken a conservative approach to new product development, making it a company lean on products but long on trust, says Brian Dixon, PhD, executive director of new product development.

New models hold promise for probiotic claim substantiation

29-Nov-2012 By Nathan Gray

Exposing healthy people to modified pathogens in a controlled clinical trial setting could be an exciting new way for industry to overcome the challenges of health claim substantiation, says Nizo Food Research expert.

How to show a clinical trial benefit in healthy populations

16-Nov-2012 By Stephen DANIELLS

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.

Resveratrol supplements backed for vascular benefits: DSM study

22-Oct-2012 By Nathan Gray

Supplementation with the red wine compound resveratrol could have ‘sustained’ benefits on cardiovascular functions and hold promise for cognitive functions, according to new research backed by DSM.

Lonza launches daily immune supplement in chews, stick packs

08-Oct-2012

Lonza, based in Basel, Switzerland, has launched a new immune supplement featuring delivery systems that take a step beyond capsules and tablets.

New patent covers pairing of Ayurvedic workhorses

01-Oct-2012 By Hank Schultz

Nutragenesis, a Brattleboro, Vt.-based ingredient supplier with a history of experience with Ayurvedic ingredients, has obtained a U.S. patent in the area of women’s health for an ashwagandha/Indian gooseberry combination called Sendara.

‘Breakout hit’ Satiereal expands NA IP & readies for fight against trademark infringements

26-Sep-2012 By Stephen Daniells

The Canadian Intellectual Property Office has granted Patent # CA 2648985 to INO’Réal and company founder Cédric Bourges for the saffron extract Satiereal, as the company builds and defends its IP on the ingredient.

Judge delivers more bad news for FTC on ‘two clinical trials’ standard

21-Jun-2012 By Elaine Watson

Further evidence that ‘competent and reliable scientific evidence’ to support claims on dietary supplements does not have to mean two well-controlled human intervention trials has emerged in a ruling in a federal court in Florida.

Dispatches from Vitafoods Europe 2012

Nutraceutical industry needs new trial design culture: Research veteran

19-Jun-2012 By Shane Starling

The multi-billion euro global nutraceutical industry will never achieve its potential until it better adapts pharma protocols – and this can be done with food nutrients, says Dr Stephen de Felice, who was the keynote speaker at the recent Vitafoods expo...

Stem cell nutrition deal establishes Marinova as undisputed world leader in Fucoidan

14-Jun-2012 By Elaine Watson

A deal to supply Stemtech International - the leading player in stem cell nutrition supplements - with one of its proprietary marine plant extracts will establish Marinova as the undisputed world leader in Fucoidan, claims the Australian biotech firm.

Nestlé centralises all clinical research in new centre

New research unit will help Nestlé quest for health claims gold

07-Jun-2012 By Nathan Gray from Lausanne, Switzerland

Nestlé is now  'better armed' to gun for EFSA approved health claims approvals, after the company centralised its clinical research efforts at a new unit in Lausanne, Switzerland.

Nestlé Clinical Development Unit inauguration

Nestlé centralises clinical research in new centre

06-Jun-2012 By Nathan Gray in Lausanne, Switzerland

Nestlé will centralise the development and management of all of its clinical trials, after the inauguration of its new clinical development unit and metabolic research centre in Lausanne, Switzerland.

Both sides claim victory as judge rules in FTC v POM false advertising case

21-May-2012 By Elaine Watson

Both sides have claimed victory in a bitter legal dispute between Californian juice maker POM Wonderful and the Federal Trade Commission (FTC) over allegations of false advertising.

The father of nutraceuticals: “The placebo effect is real”

20-Apr-2012 By Shane Starling

Veteran researcher Dr Stephen de Felice invented the term ‘nutraceutical’ in 1989 and ever since he has been imploring the sector to design and conduct better human clinical trials to back the medicinal potential of bodily nutritional interventions.

Dispatches from Nutracon, Anaheim

Formulating the perfect cognitive health beverage: Feed your mind, don’t confuse it further

09-Mar-2012 By Elaine Watson

The thinking behind ingredient selection and dosage in some cognitive health beverages is often “pretty confused”, according to the neuropsychologist behind brain-friendly functional beverage Nawgan.

Study supports potential anti-cancer effects of selenium-enriched yeast

25-Jan-2012 By Stephen Daniells

Selenium enrichment of yeast changes the expression of certain proteins in the organism, five of which have reported anti-cancer effects, says a new study from Penn State.

Kalahari tribe throws weight at Unilever over hoodia rejection

19-Dec-2011 By Shane Starling

South Africa’s San people say food giant Unilever was working off inaccurate research data when it decided to bin a €20m investment in hoodia gordonii, the Kalahari cactus the San have used for centuries to curb hunger pangs.

New research suggests top-selling brain supplement does what it says on the tin

13-Dec-2011 By Elaine Watson

New, as yet unpublished, research on top-selling cognitive function supplement FOCUSfactor suggests it could improve memory, concentration, and focus in healthy adults.

CRN challenges industry to develop an ‘aggressive agenda of scientific investigation’

20-Oct-2011 By Stephen Daniells in Rancho Palos Verdes

The dietary supplements industry can demonstrate the benefits of its products by developing its ‘own aggressive agenda of investigation’ and not sit back and let ‘outsiders’ conduct research into dietary supplements, said Steve Mister, president &...

Apps turn iPads & iPods into consent & compliance tools

08-Aug-2011 By Nick Taylor

Systemedicus has developed informed consent and patient compliance apps for iPads and iPods and is looking to license the tools to CROs and sponsors.

Chromadex-Cott team-up to extend synergies of pterostilbene and grape polyphenols

01-Jul-2011 By Stephen Daniells

Cott Beverages Inc., and ChromaDex Inc. have entered into a licensing and supply agreement for the joint development of a proprietary ingredient blend combining the latter’s pterostilbene ingredient and the former’s grape extract.

Curcumin-soy formulation may boost absorption 60-fold: Indena study

06-Apr-2011 By Stephen Daniells

Formulating curcumin with soy compounds boost curcuminoid absorption 29-fold, compared with curcumin only, say new results of a study sponsored by Indena.

F&S declares pTeroPure as ‘Most Promising Ingredient’

25-Mar-2011

Frost & Sullivan has hailed Chromadex’s pTeroPure as the 2010 North American Health Ingredients Most Promising Ingredient of the Year, and expects huge market potential for pterostilbene.

Industry welcomes NCCAM five-year plan

08-Feb-2011 By Shane Starling

Industry is singing the praises of a “pragmatic” National Center for Complementary and Alternative Medicine (NCCAM) five-year plan that it says has responded to its concerns, along with those of consumers and academics, about CAM science and its translation...

Special edition: Outsourcing

Clinical trial success: Design and recruitment

25-Jan-2011 By Nathan Gray

Designing a clinical trial correctly from the beginning is the most important issue for success, while a ready supply of volunteers for natural product clinical trials takes the pressure off patient recruitment, says the CEO of a CRO.

Special edition: Outsourcing

GMPs boosting need for contract analytical prowess

24-Jan-2011 By Stephen Daniells

The introduction of good manufacturing practices (GMPs) is a boon for contract analytical services, and those with special services to offer are standing out from the crowd.

Special edition: Outsourcing

CROs (slowly) piece together EFSA's health claim science puzzle

21-Jan-2011 By Shane Starling

In the second part of this special series on global outsourcing trends NutraIngredients explores how the European Union nutrition and health claims regulation (NHCR) is impacting activity in the contract research organisation (CRO) sector.

Dannon on FTC settlement: “Our claims remain intact”

16-Dec-2010 By Shane Starling

Dannon says its year-long negotiations with the Federal Trade Commission that resulted in a $21m settlement and modifications placed on its health statements, has not altered the core claims for its multi-million dollar selling probiotic yoghurts.

Special edition: Asia

India’s nutrition boom produces contract research boon

23-Sep-2010 By Stephen Daniells

As the need for scientific support for potential health claims for healthy foods increases, India is leveraging its pharmaceutical expertise to take a bite of the functional foods pie.

ESM Technologies self-affirms GRAS for egg membrane ingredients

17-Sep-2010 By Stephen Daniells

Missouri-based ESM Technologies has self-affirmed the Generally Recognized As Safe (GRAS) status for its patented, clinically proven ingredient, allowing it to expand into food and beverages.