Optimizing clinical trial design for assessing the efficacy of functional foods

Nutrition Reviews
Suhad AbuMweisPeter J H Jones

Abstract

Randomized clinical trial data are capable of providing strong experimental evidence to establish causal relationships between functional food components and health and disease/disease risk. However, clinical studies must be well designed in order to optimize the quality of the data they provide. The purpose of this review is to identify design elements that maximize the quality of clinical trials examining the efficacy of functional foods. Both observational studies and experimental trials can provide useful data for identifying diet-disease relationships. Two experimental designs are conventionally used: parallel and crossover. Each of these designs possesses advantages and disadvantages. For certain functional ingredients, selection of an appropriate control arm is straightforward, while for others it is challenging. Studies should be short enough to optimize subject compliance, be cost effective, and avoid high subject dropout rates, while being lengthy enough to ensure biological efficacy. The dose, frequency, and diurnal timing of intake of the active food ingredient all need to be chosen carefully. Randomized clinical trials testing the efficacy of functional foods may use both validated and emerging surrogate endpoints ...Continue Reading

References

Jan 1, 1990·Statistics in Medicine·J M Lang
Apr 1, 1989·Statistics in Medicine·J WittesJ Probstfield
Nov 16, 1995·The New England Journal of Medicine·T A MiettinenE Vartiainen
Jan 23, 1998·JAMA : the Journal of the American Medical Association·A Pablos-MéndezS Shea
Jun 20, 1998·BMJ : British Medical Journal·B Sibbald, C Roberts
Mar 7, 2000·The Journal of Nutrition·K H van Het HofJ G Hautvast
Dec 2, 2000·The American Journal of Clinical Nutrition·A Drewnowski, C Gomez-Carneros
Jan 16, 2002·Current Opinion in Lipidology·Paul Nestel
Sep 3, 2002·Computer Methods and Programs in Biomedicine·Rodolphe ThiébautDaniel Commenges
Oct 17, 2002·The Medical Journal of Australia·Anthony C Keech, Val Gebski
Mar 4, 2003·The Journal of Nutrition·Lenore Arab
Mar 18, 2003·Public Health Nutrition·Sheila A Bingham
Mar 29, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·John R JohnsonRichard Pazdur
May 6, 2003·Journal of Lipid Research·Peter J H JonesMarie-Pierre St-Onge
Aug 5, 2003·BMJ : British Medical Journal·Tim LaneMark Emberton
Aug 13, 2003·Mayo Clinic Proceedings·Martijn B KatanUNKNOWN Stresa Workshop Participants
Sep 23, 2003·Nutrition Journal·K Akhilender Naidu
Oct 24, 2003·The New England Journal of Medicine·Teri Manolio
Feb 7, 2004·Arteriosclerosis, Thrombosis, and Vascular Biology·Sridevi DevarajSonia Vega-López
Feb 27, 2004·International Journal of Nursing Practice·Leanne AitkenChristine Madronio
Apr 9, 2004·Lipids in Health and Disease·Alvin BergerSuhad S Abumweis
May 26, 2004·The American Journal of Clinical Nutrition·Yanwen Wang, Peter J H Jones
Jun 3, 2004·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Gary J KelloffGeorge F Vande Woude
Jun 4, 2004·Journal of the American Dietetic Association·Lisa Rainer, Cynthia J Heiss
Dec 8, 2004·Statistics in Medicine·Raquel GarciaErik Cobo
Aug 4, 2005·Journal of Biological Rhythms·Elizabeth B Klerman
Dec 24, 2005·American Journal of Physiology. Heart and Circulatory Physiology·Martin E Young
Mar 3, 2007·Pharmacological Reviews·James H RevkinDavid G Orloff
Aug 2, 2007·The British Journal of Nutrition·Jeremy P E SpencerJohn C Mathers
Jan 16, 2008·Oral and Maxillofacial Surgery Clinics of North America·Colin S Bell
Jan 24, 2008·Journal of Food Science·K YeuS-Y Lee
Feb 8, 2008·Nutrition Reviews·Crystal M RasnakeTherese M Heinonen
May 9, 2008·Critical Reviews in Food Science and Nutrition·Mohammed H Moghadasian
Jun 5, 2008·European Journal of Clinical Nutrition·S S AbuMweisP J H Jones
Aug 1, 2008·Nutrition Reviews·Mélanie PlourdePeter Jh Jones

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Citations

Jan 25, 2012·The British Journal of Nutrition·Robert W WelchUNKNOWN International Life Sciences Institute Europe Functional Foods Task Force
Aug 28, 2014·Critical Reviews in Food Science and Nutrition·Rohan AmeratungaSee-Tarn Woon
Jun 16, 2012·Metabolism: Clinical and Experimental·Leah G GillinghamPeter J H Jones
Feb 9, 2020·Nutrients·Nurul 'Izzah IbrahimIsa Naina Mohamed
Sep 29, 2011·International Journal of Food Sciences and Nutrition·Ileana Baldi, Dario Gregori
Jan 24, 2019·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Mariane LutzIván Palomo
Jan 21, 2017·Risk Analysis : an Official Publication of the Society for Risk Analysis·Oliver Todt, José Luis Luján
Mar 2, 2021·Drug Discoveries & Therapeutics·Atsushi MiyashitaKazuhisa Sekimizu

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