Design of the Building Research in CRC prevention (BRIDGE-CRC) trial: a 6-month, parallel group Mediterranean diet and weight loss randomized controlled lifestyle intervention targeting the bile acid-gut microbiome axis to reduce colorectal cancer risk among African American/Black adults with obesity

Trials

Study Protocol

Jason Ridlon¹  H. Rex Gaskins²  Beatriz Penalver Bernabe³  Alyshia Hamm⁴  Kate Cares⁴  Patricia Wolf⁵  Robert S. Chapkin⁶  Laurie A. Davidson⁶  Ivan Ivanov⁷  Lara Blumstein⁸  Andrew McLeod⁸  Linda Schiffer⁸  Mirjana Antonic⁸  Michael Berbaum⁸  Jen Sanchez-Flack⁹  Marian Fitzgibbon⁹  Lisa Tussing-Humphreys^1,10  Lauren R. Williams^1,11 

[1] Department of Animal Sciences, University of Illinois Urbana-Champaign, Urbana, IL, USA;Division of Nutritional Sciences, University of Illinois Urbana-Champaign, Urbana, IL, USA;Carl R. Woese Institute for Genomic Biology, University of Illinois Urbana-Champaign, Urbana, IL, USA;Cancer Center at Illinois, University of Illinois Urbana-Champaign, Urbana, IL, USA;Department of Animal Sciences, University of Illinois Urbana-Champaign, Urbana, IL, USA;Division of Nutritional Sciences, University of Illinois Urbana-Champaign, Urbana, IL, USA;Carl R. Woese Institute for Genomic Biology, University of Illinois Urbana-Champaign, Urbana, IL, USA;Cancer Center at Illinois, University of Illinois Urbana-Champaign, Urbana, IL, USA;Department of Biomedical and Translational Sciences, University of Illinois Urbana-Champaign, Urbana, IL, USA;Department of Pathobiology, University of Illinois Urbana-Champaign, Urbana, IL, USA;Department of Biomedical Engineering, University of Illinois Chicago, Chicago, IL, USA;Department of Kinesiology and Nutrition, University of Illinois Chicago, Chicago, IL, USA;Department of Nutrition Science, Purdue University, West Lafayette, IN, USA;Department of Nutrition, Program in Integrative Nutrition & Complex Diseases, and Center for Environmental Health Research, Texas A&M University, College Station, TX, USA;Department of Nutrition, Program in Integrative Nutrition & Complex Diseases, and Center for Environmental Health Research, Texas A&M University, College Station, TX, USA;Department of Veterinary Physiology & Pharmacology, and Center for Environmental Health Research, Texas A&M University, College Station, TX, USA;Institute for Health Research and Policy, University of Illinois Chicago (UIC), Chicago, IL, USA;Institute for Health Research and Policy, University of Illinois Chicago (UIC), Chicago, IL, USA;Department of Pediatrics, University of Illinois Chicago, Chicago, IL, USA;University of Illinois Cancer Center, University of Illinois Chicago, Chicago, IL, USA;Institute for Health Research and Policy, University of Illinois Chicago (UIC), Chicago, IL, USA;University of Illinois Cancer Center, University of Illinois Chicago, Chicago, IL, USA;Department of Kinesiology and Nutrition, University of Illinois Chicago, Chicago, IL, USA;Mile Square Health Center, University of Illinois Chicago, Chicago, IL, USA;

关键词: Cancer health disparities;    Colorectal cancer;    Mediterranean diet;    Weight loss;    Gut microbiome;    Bile acids;    Nutrition;   

DOI  :  10.1186/s13063-023-07115-4

 received in 2022-11-17, accepted in 2023-01-23,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundAmong all racial/ethnic groups, people who identify as African American/Blacks have the second highest colorectal cancer (CRC) incidence in the USA. This disparity may exist because African American/Blacks, compared to other racial/ethnic groups, have a higher prevalence of risk factors for CRC, including obesity, low fiber consumption, and higher intakes of fat and animal protein. One unexplored, underlying mechanism of this relationship is the bile acid-gut microbiome axis. High saturated fat, low fiber diets, and obesity lead to increases in tumor promoting secondary bile acids. Diets high in fiber, such as a Mediterranean diet, and intentional weight loss may reduce CRC risk by modulating the bile acid-gut microbiome axis. The purpose of this study is to test the impact of a Mediterranean diet alone, weight loss alone, or both, compared to typical diet controls on the bile acid-gut microbiome axis and CRC risk factors among African American/Blacks with obesity. Because weight loss or a Mediterranean diet alone can reduce CRC risk, we hypothesize that weight loss plus a Mediterranean diet will reduce CRC risk the most.MethodsThis randomized controlled lifestyle intervention will randomize 192 African American/Blacks with obesity, aged 45–75 years to one of four arms: Mediterranean diet, weight loss, weight loss plus Mediterranean diet, or typical diet controls, for 6 months (48 per arm). Data will be collected at baseline, mid-study, and study end. Primary outcomes include total circulating and fecal bile acids, taurine-conjugated bile acids, and deoxycholic acid. Secondary outcomes include body weight, body composition, dietary change, physical activity, metabolic risk, circulating cytokines, gut microbial community structure and composition, fecal short-chain fatty acids, and expression levels of genes from exfoliated intestinal cells linked to carcinogenesis.DiscussionThis study will be the first randomized controlled trial to examine the effects of a Mediterranean diet, weight loss, or both on bile acid metabolism, the gut microbiome, and intestinal epithelial genes associated with carcinogenesis. This approach to CRC risk reduction may be especially important among African American/Blacks given their higher risk factor profile and increased CRC incidence.Trial registrationClinicalTrials.gov NCT04753359. Registered on 15 February 2021.

【 授权许可】

CC BY   
© The Author(s) 2023

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