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Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods

  • Robert W. Welch (a1), Jean-Michel Antoine (a2), Jean-Louis Berta (a3), Achim Bub (a4), Jan de Vries (a5), Francisco Guarner (a6), Oliver Hasselwander (a7), Henk Hendriks (a8), Martin Jäkel (a9), Berthold V. Koletzko (a10), Chris C. Patterson (a11), Myriam Richelle (a12), Maria Skarp (a13), Stephan Theis (a14), Stéphane Vidry (a13) and Jayne V. Woodside (a11)...
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.

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Copyright
Corresponding author
Correspondence: ILSI Europe a.i.s.b.l., Avenue E. Mounier 83, Box 6 – 1200 Brussels, Belgium, fax: +32 2 762 00 44, email: publications@ilsieurope.be
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This list contains references from the content that can be linked to their source. For a full set of references and notes please see the PDF or HTML where available.

1 EJ Brunner , K Rees , K Ward , (2007) Dietary advice for reducing cardiovascular risk. The Cochrane Database of Systematic Reviews, issue 4, CD002128.

24 S Piantadosi (2005) Clinical Trials: A Methodological Perspective, 2nd ed.Hoboken, NJ: John Wiley & Sons.

25 D Machin & P Fayers (2010) Randomized Clinical Trials: Design, Practice and Reporting. Chichester: Wiley-Blackwell.

26 LM Friedman , CD Furberg & DL DeMets (2010) Fundamentals of Clinical Trials, 4th ed.New York: Springer.

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British Journal of Nutrition
  • ISSN: 0007-1145
  • EISSN: 1475-2662
  • URL: /core/journals/british-journal-of-nutrition
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