"The scientific knowledge available to date cannot be ignored and should be a starting point for the assessment of the totality of the available data and the strength, consistency and biological plausibility of the evidence," said Professor Hans Biesalski, head of the University of Hohenheim Department of Biological Chemistry and Nutrition in Stuttgart, Germany.
"Evidence based medicine is clearly not appropriate for the evaluation of claims made on foods and what is needed in the process of evaluating Article 13.1 claims is to define evidence-based nutrition, which embraces state-of-the-art nutrition science, and stimulates future academic research. This approach does not mean to have a lower scientific level. Indeed, specific designs should be developed to estimate the effect of ’non-xenobiotics’ on human health“.
The 13 academics met at a conference at the University of Hohenheim last year, and have published a position paper that summarises their views on the NHCR in the October, 2011, edition of Nutrition journal.
In the paper they suggest: “The terminologies of ‘grading of evidence’ which is widely used for the development of nutritional recommendations and which may result in differentiation of claims wordings dependent on the strength of the supporting evidence, constitute a valuable concept that needs to be further explored and applied.”
They go on: “There is a need to translate the impact of nutrition on health and wellness (e.g., cognitive performance, inflammatory processes,cardiovascular disease risk, etc.) into a framework of biomarkers and physiologic responses sufficient to quantify and substantiate these relations for the maintenance of a beneficial bodily function.”
The researchers use vitamin A and Age-related macular degeneration (AMD), probiotics and immunity, antixioxidants, botanicals and glycaemic index foods and wellness as examples where the medicinal approach was failing to acknowledge statistically significant nutrition science.
"Its own nutritional methodologies"
“We chose these case studies in order to address the extent to which an evidence-based benefit is a reliable endpoint, and the extent to which data from clinical studies of disease states can be used as supportive evidence for health effects,” said Professor Biesalski.
“They also enabled us to consider how to assess other factors, such as the different effects of the various dietary nutritional components on systemic parameters, for example, the individual effects of the various types of fatty acids in the diet on blood lipids.”
The researchers concluded: “Research in the field of nutrition has entered a new stage, where it deserves its own nutritional methodologies that are distinct and more diverse than evidence- based medicine.”
“It requires redefining health in terms of an individual’s potential to adapt to internal and external stimuli rather than using the pharmaceutical paradigm. New ways of addressing nutritional and functional effects of foods and food components are being developed and offer opportunities for future research.”
“Any claims assessment system that is not able to accommodate the wide spectrum of health effects should be adapted to reflect the science available. It should be capable of stimulating these developments toward new research and the development of innovative products and useful information to the benefit of the consumer, including but not limited to public health messages.”
The work was supported financially by the European Responsible Nutrition Alliance (ERNA).
‘26th Hohenheim Consensus Conference, September 11, 2010 Scientific substantiation of health claims: Evidence-based nutrition’
Authors: Hans Konrad Biesalski PhD, Peter J. Aggett PhD, Robert Anton PhD, Paul S. Bernstein MD, PhD, Jeffrey Blumberg PhD. Robert P. Heaney PhD, Jeya Henry PhD, John M. Nolan PhD, David P. Richardson PhD, Ben van Ommen PhD, Renger F. Witkamp PhD, ,Ger T. Rijkers PhD, Iris Zöllner PhD.