The European Commission backed DO-HEALTH study (VitaminD3-Omega3-Home Exercise-Healthy Ageing and Longevity Trial) will be Europe's largest healthy ageing study, and is expected to provide solid evidence for the efficacy and safety of three simple preventive interventions: vitamin D, omega-3 fatty acids and a simple home exercise programme, says the projects principle investigator Professor Heike Bischoff-Ferrari.
Vitamin D expert Bischoff-Ferrari, who is director of the Centre on Aging and Mobility at Zurich University, told NutraIngredients that the new 12.8 million Euro research project“is an attempt to create evidence for three simple strategies to improve health at older age.”
She explained that there is a wealth of information in the scientific literature that suggests vitamin D, omega-3 fatty acids, and exercise can all help to improve health endpoints. However, the evidence for such strategies has so far come from epidemiological studies and mechanistic studies.
“What we lack today is evidence from a large clinical trial, and without that evidence we cannot promote health recommendations,” said Bischoff-Ferrari.
The launch of the study follows calls by Professor Bischoff-Ferarri to see a greater amount of EU driven research in areas such as vitamin D – as there is limited potential for intellectual property (IP) that generally drives industry backing.
“The problem is vitamin D has limited Intellectual Property (IP) potential, it is a pure public health intervention,” Bischoff-Ferrari told NutraIngredients last year. “There needs to be more double blind, randomised clinical trials but we lack these because it is difficult to gain corporate interest.”
She said the European Commission has now provided a framework which enabled the DO health project to be launched.
“DO HEALTH is a new way to work together for an important public health goal. Industry partners are involved, and they will basically get a benefit out of the knowledge that is created – they don’t get intellectual property,” she told this publication.
The three main industry partners for the DO health project are DSM, Nestle Health Sciences, and Roche Diagnostics.
Bischoff-Ferarri said the European Commission backing has also resulted in the group having to think more about implementation of their research findings: “To think about what comes after the results, and how the information can reach the public.”
“We have a whole work package on implementation, so you have to start form the very beginning thinking about how this information will get to the public,” she said.
Building the evidence
Bischoff-Ferrarri revealed that the project will begin recruiting more than 2000 participants in five European countries as of May 2012.
The trial will follow the ‘healthy-at-start’ participants – all aged 70 and older – for three years.
The study will investigate biomarkers for five key health indicators: fracture risk, blood pressure, lower extremity function, cognitive function, and rate of infections. In addition, other important aspects of senior health, including information on falls and osteoarthritis, as well as blood biomarkers, will be investigated, said Bischoff-Ferarri.
“This is the next important step,” she explained, noting that the DO HEALTH study will run alongside the US based VITAL trial.
“We are partners on a global level, creating evidence for both the European and US population – but also the trials have been designed to complement each other,” explained the vitamin D expert.
She said that whilst the two trials would use similar interventions (at the same doses), the US based VITAL trial would investigate just vitamin D and omega-3 – focusing on the effects for cardiovascular health and cancer incidence in an aging population (of 60 and over).
“The DO HEALTH trial is the more ‘hands on trial’,” she said, noting that it will involve people who older and more frail than the VITAL study.
“We are powered for several important endpoints, but we are not powered for cancer for example,” said Bischoff-Ferarri. “We are much more interested in function and biomarkers that you can only monitor closely by a physical exam,” she said.
“There are important knowledge gaps to fill,” said Bischoff-Ferarri.
“For example we do not have any kind of reference values for individuals aged 65 and over. So everything we currently measure has to be referenced to a middle aged population,” she explained.