title: Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods.
abstract: There is substantial evidence to link what we eat to the reduction of the risk of major chronic diseases and/or the improvement of functions. Thus, it is important for public health agencies and the food industry to facilitate the consumption of foods with particular health benefits by providing consumer products and messages based on scientific evidence. Although fragmentary advice is available from a range of sources, there is a lack of comprehensive scientific guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Such guidelines are needed both to support nutrition science in general, and to facilitate the substantiation of health claims. In the present study, which presents the consensus view of an International Life Sciences Institute Europe Expert Group that included senior scientists from academia and industry, the term 'foods' refers to foods, dietary supplements and food constituents, but not to whole diets. The present study is based on an initial survey of published papers, which identified the range and strengths and weaknesses of current methodologies, and was finalised following exchanges between representatives from industry, academia and regulatory bodies. The major factors involved in the design, conduct and reporting of studies are identified, summarised in a checklist table that is based on the Consolidated Standards of Reporting Trials guidelines, and elaborated and discussed in the text.
authors: Northern Ireland Centre for Food and Health, School of Biomedical Sciences, University of Ulster, Coleraine BT52 1SA, UK.
authors: Robert W
authors: RW
authors: Welch
authors: Jean-Michel
authors: JM
authors: Antoine
authors: Jean-Louis
authors: JL
authors: Berta
authors: Achim
authors: A
authors: Bub
authors: Jan
authors: J
authors: de Vries
authors: Francisco
authors: F
authors: Guarner
authors: Oliver
authors: O
authors: Hasselwander
authors: Henk
authors: H
authors: Hendriks
authors: Martin
authors: M
authors: Jäkel
authors: Berthold V
authors: BV
authors: Koletzko
authors: Chris C
authors: CC
authors: Patterson
authors: Myriam
authors: M
authors: Richelle
authors: Maria
authors: M
authors: Skarp
authors: Stephan
authors: S
authors: Theis
authors: Stéphane
authors: S
authors: Vidry
authors: Jayne V
authors: JV
authors: Woodside
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000592:standards*; D002986:Clinical Trials as Topic; D004032:Diet / Q000009:adverse effects; D005060:Europe; D055317:Evidence-Based Practice; D005515:Food Labeling / Q000331:legislation & jurisprudence; D055951:Functional Food / Q000592:standards; D006801:Humans; D007881:Legislation, Food; D011642:Publications / Q000592:standards; D012107:Research Design / Q000592:standards*