How to design nutritional intervention trials to slow cognitive decline in apparently healthy populations and apply for efficacy claims: A statement from the international academy on nutrition and aging task force
- First Online:
- 253 Downloads
interventions are crucial as they offer simple and inexpensive public health solutions that will be useful over the long term use. A Task Force on designing trials of nutritional interventions to slow cognitive decline in older adults was held in Toulouse in September 2012. The aim of the Task Force was to bring together leading experts from academia, the food industry and regulatory agencies to determine the best trial designs that would enable us to reach our goal of maintaining or improving cognitive function in apparently healthy aging people. An associated challenge for this Task Force was to determine the type of trials required by the Public Food Agencies for assessing the impact of nutritional compounds in comparison to well established requirements for drug trials. Although the required quality of the study design, rationale and statistical analysis remains the same, the studies designed to show reduction of cognitive decline require a long duration and the objectives of this task force was to determine best design for these trials. Two specific needs were identified to support trials of nutritional interventions: 1- Risk-reduction strategies are needed to tackle the growing burden of cognitive decline that may lead to dementia, 2- Innovative study designs are needed to improve the quality of these studies.
Key wordsCognitive decline aging design nutritional intervention trials efficacy claims
Unable to display preview. Download preview PDF.
- 1.World Health Organization. Diet, Nutrition and the Prevention of Chronic Diseases: report of a joint WHO/FAO expert consultation. Geneva, Switzerland; 2003 WHO Technical Reports Series no 916Google Scholar
- 5.Kesse-Guyot E, Amieva H, Castetbon K, Henegar A, Ferry M, Jeandel C, et al. Adherence to nutritional recommendations and subsequent cognitive performance: findings from the prospective Supplementation with Antioxidant Vitamins and Minerals 2 (SU.VI.MAX 2) study. Am J Clin Nutr. 2011; 93(1):200–210.PubMedCrossRefGoogle Scholar
- 14.Kado DM, Karlamangla AS, Huang MH, Troen A, Rowe JW, Selhub J, et al. Homocysteine versus the vitamins folate, B6, and B12 as predictors of cognitive function and decline in older high-functioning adults: MacArthur Studies of Successful Aging. Am J Med. 2005; 118(2):161–167.PubMedCrossRefGoogle Scholar
- 26.European Food Safety Authority. Guidance on the scientific requirements for health claims related to functions of the nervous system, including psychological functions. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Journal [serial on the Internet]. 2012 Date; 10(7): Available from: http://www.efsa.europa.eu/en/efsajournal/doc/2816.pdf.
- 27.Gillette-Guyonnet S, Andrieu S, Dantoine T, Dartigues JF, Touchon J, Vellas B, et al. Commentary on “A roadmap for the prevention of dementia II. Leon Thal Symposium 2008.” The Multidomain Alzheimer Preventive Trial (MAPT): a new approach to the prevention of Alzheimer’s disease. Alzheimer’s & dementia: J Alzheimer’s Association. 2009; 5(2):114–121.CrossRefGoogle Scholar
- 37.Cesari M. Frailty and aging. J Frailty Aging. 2012:3–6.Google Scholar
- 40.Editorial: Culture shock. Health-benefit claims for Europe’s foods must at last be substantiated by science. Nature. 2013;493:133–134.Google Scholar