British Journal of Nutrition

Full Papers

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

Robert W. Welcha1, Jean-Michel Antoinea2, Jean-Louis Bertaa3, Achim Buba4, Jan de Vriesa5, Francisco Guarnera6, Oliver Hasselwandera7, Henk Hendriksa8, Martin Jäkela9, Berthold V. Koletzkoa10, Chris C. Pattersona11, Myriam Richellea12, Maria Skarpa13, Stephan Theisa14, Stéphane Vidrya13 and Jayne V. Woodsidea11

a1 Northern Ireland Centre for Food and Health, School of Biomedical Sciences, University of Ulster, Coleraine BT52 1SA, UK

a2 Danone Research, Route Départementale 128, FR-91767, Palaiseau Cedex, France

a3 Consultant, 37 rue Boileau, FR-92120 Montrouge, France

a4 Max Rubner-Institute, Federal Research Centre for Nutrition and Food, Haid-und-Neu-Strasse 9, DE-76131, Karlsruhe, Germany

a5 De Vries Nutrition Solutions, Reuvekamp 26, 7213 CE Gorssel, The Netherlands

a6 Digestive System Research Unit, Hospital General Vall d'Hebron, CIBEREHD, Passeig Vall d'Hebron, 119-129, ES-08035 Barcelona, Spain

a7 Danisco, 43 London Road, Reigate, RH2 9PW, Surrey, UK

a8 TNO Quality of Life, PO Box 360, NL-3700 AJ Zeist, The Netherlands

a9 Unilever, Olivier van Noortlaan 120, NL-3133 AT Vlaardingen, The Netherlands

a10 Division of Metabolic and Nutritional Medicine, Dr Von Hauner Children's Hospital, University of Munich Medical Centre, Lindwurmstrasse, 4, DE-80337 Munich, Germany

a11 Centre for Public Health, Queen's University Belfast, Belfast BT12 6BJ, UK

a12 Nestlé Research Center, PO Box 44, Vers-chez-les-blanc, CH-1000 Lausanne, Switzerland

a13 ILSI Europe a.i.s.b.l., Avenue E. Mounier 83, Box 6, BE-1200 Brussels, Belgium

a14 Südzucker/BENEO Group, Wormserstrasse 11, DE-67283 Obrigheim, Germany

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.

(Received December 01 2010)

(Revised May 18 2011)

(Accepted May 31 2011)

Correspondence:

c1 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

Footnotes

Abbreviations: AE, adverse event; CONSORT, Consolidated Standards of Reporting Trials