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Assessing the impact of the diet on cardiometabolic outcomes: are multiple measurements post-intervention necessary?

Abstract

The purpose of this study was to examine how using the mean of two consecutive measurements vs. one measurement post-treatment influences the sample size required to detect changes in cardiometabolic risk factors in dietary studies. For a given statistical power, using the mean of two measurements taken on consecutive days post-treatment instead of a single measurement significantly reduces the sample size required to observe changes in triglyceride, total apolipoprotein B100, and C-reactive protein concentrations in the context of a supplementation study. In the context of a controlled-feeding study, this gain is seen only in the case of change in triglyceride concentrations.

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Acknowledgements

JA is a recipient of PhD Scholarships from the Canadian Institutes of Health Research (CIHR) and Fonds de recherche du Québec–Santé (FRQ-S).

Author contributions

The authors’ responsibilities were as follows: BL, PC, AT, PJHJ, PKE, SGW, PWC, and DJAJ designed and obtained funding for the two RCTs used in this analysis. JA and DT performed statistical analyses. JA wrote the manuscript. BL had primary responsibility for final content. All authors critically revised the manuscript and contributed intellectually to its development, provided final approval of the submitted manuscript, had full access to all of the data in the study, take responsibility for the integrity of the data and the accuracy of the data in the analysis, affirm that the article is an honest, accurate, and transparent account of the study being reported and that no important aspects of the study have been omitted.

Funding

JA is a recipient of PhD Scholarships from the Canadian Institutes of Health Research (CIHR) and Fonds de recherche du Québec–Santé (FRQ-S). All authors completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author). Disclaimers and other potential conflicts of interest are listed at the end of the manuscript.

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Correspondence to Benoît Lamarche.

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Conflict of interest

BL has received funding in the last 5 years from the Canadian Institutes for Health Research, the Natural Sciences and Engineering Research Council of Canada, The Fonds de recherche du Québec- Santé (FRQ-S), The Ministère de la santé et des services sociaux du Québec, Agriculture and Agri-Food Canada (Growing Forward program supported by Canola Council of Canada, Flax Council of Canada, Dow Agrosciences, Dairy Farmers of Canada), National Dairy Council, Dairy Australia, Merck Frosst, Pfizer and Atrium Innovations for which Douglas Laboratories manufacture and market omega-3 supplements. PC received funding in the last 5 years from the Canadian Institutes for Health Research, Agriculture, and Agri-Food Canada (Growing Forward program supported by the Dairy Farmers of Canada (DFC), Canola Council of Canada, Flax Council of Canada, and Dow Agrosciences), National Dairy Council, Dairy Australia, Merck Frosst, Pfizer, Amgen, Sanofi, Kaneka Corporation, and Atrium Innovations. AT received funding from the Canadian Institutes of Health Research (CIHR), Fonds de recherche du Québec–Santé (FRQ-S) and Natural Sciences and Engineering Research Council of Canada as well as funding from Johnson & Johnson Medical Companies, Pfizer and Medtronic for studies unrelated to this manuscript. DJAJ has received research grants from Saskatchewan Pulse Growers, the Agricultural Bioproducts Innovation Program through the Pulse Research Network, the Advanced Foods and Material Network, Loblaw Companies Ltd., Unilever, Barilla, the Almond Board of California, Agriculture and Agri-food Canada, Pulse Canada, Kellogg’s Company, Canada, Quaker Oats, Canada, Procter & Gamble Technical Centre Ltd., Bayer Consumer Care, Springfield, NJ, Pepsi/Quaker, International Nut & Dried Fruit (INC), Soy Foods Association of North America, the Coca-Cola Company (investigator initiated, unrestricted grant), Solae, Haine Celestial, the Sanitarium Company, Orafti, the International Tree Nut Council Nutrition Research and Education Foundation, the Peanut Institute, the Canola and Flax Councils of Canada, the Calorie Control Council (CCC), the CIHR, the Canada Foundation for Innovation and the Ontario Research Fund. He has received in-kind supplies for trial as a research support from the Almond board of California, Walnut Council of California, American Peanut Council, Barilla, Unilever, Unico, Primo, Loblaw Companies, Quaker (Pepsico), Pristine Gourmet, Bunge Limited, Kellogg Canada, WhiteWave Foods. He has been on the speaker’s panel, served on the scientific advisory board and/or received travel support and/or honoraria from the Almond Board of California, Canadian Agriculture Policy Institute, Loblaw Companies Ltd, the Griffin Hospital (for the development of the NuVal scoring system, the Coca-Cola Company, EPICURE, Danone, Diet Quality Photo Navigation (DQPN), FareWell, Verywell, True Health Initiative, Saskatchewan Pulse Growers, Sanitarium Company, Orafti, the Almond Board of California, the American Peanut Council, the International Tree Nut Council Nutrition Research and Education Foundation, the Peanut Institute, Herbalife International, Pacific Health Laboratories, Nutritional Fundamental for Health, Barilla, Metagenics, Bayer Consumer Care, Unilever Canada and Netherlands, Solae, Kellogg, Quaker Oats, Procter & Gamble, the Coca-Cola Company, the Griffin Hospital, Abbott Laboratories, the Canola Council of Canada, Dean Foods, the California Strawberry Commission, Haine Celestial, PepsiCo, the Alpro Foundation, Pioneer Hi-Bred International, DuPont Nutrition and Health, Spherix Consulting and WhiteWave Foods, the Advanced Foods and Material Network, the Canola and Flax Councils of Canada, the Nutritional Fundamentals for Health, Agri-Culture and Agri-Food Canada, the Canadian Agri-Food Policy Institute, Pulse Canada, the Saskatchewan Pulse Growers, the Soy Foods Association of North America, the Nutrition Foundation of Italy (NFI), Nutra-Source Diagnostics, the McDougall Program, the Toronto Knowledge Translation Group (St. Michael’s Hospital), the Canadian College of Naturopathic Medicine, The Hospital for Sick Children, the Canadian Nutrition Society (CNS), the American Society of Nutrition (ASN), Arizona State University, Paolo Sorbini Foundation and the Institute of Nutrition, Metabolism and Diabetes. He received an honorarium from the United States Department of Agriculture to present the 2013 W.O. Atwater Memorial Lecture. He received the 2013 Award for Excellence in Research from the International Nut and Dried Fruit Council. He received funding and travel support from the Canadian Society of Endocrinology and Metabolism to produce mini cases for the Canadian Diabetes Association (CDA). He is a member of the International Carbohydrate Quality Consortium (ICQC). His wife is a director and partner of Glycemic Index Laboratories, Inc., and his sister received funding through a grant from the St. Michael’s Hospital Foundation to develop a cookbook for one of his studies. PJHJ has receiving grants from the Advanced Foods and Materials Network, Agriculture and Agri-Food Canada (Growing Forward program supported by the Dairy Farmers of Canada, Canola Council of Canada, Flax Council of Canada, and Dow Agrosciences), Danone, Enzymotec, Unilever, the Canadian Institutes of Health Research and Canada Research Chair Endowment of the Federal Government of Canada. SGW is a consultant for the Canola Council of Canada. PKE serves on the Avocado Nutrition Science Advisory and HUMAN Scientific Advisory Board and has grants from the National Cattlemen’s Beef Association, the Peanut Institute, the International Nut and Dried Fruit Council Foundation, the California Strawberry Commission, Ocean Spray Cranberries, Inc., McCormick Science Institute, and Hass Avocado Board. DT has received funding from the Natural Sciences and Engineering Research Council of Canada, the Canadian Institutes of Health Research, the Fondation du CHU de Québec – Université Laval and the Fonds Vert du Québec. Other authors have no disclosures.

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Allaire, J., Talbot, D., Couture, P. et al. Assessing the impact of the diet on cardiometabolic outcomes: are multiple measurements post-intervention necessary?. Eur J Clin Nutr 73, 1546–1550 (2019). https://doi.org/10.1038/s41430-018-0257-0

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