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CARBFUNC

The CARBFUNC study is a 2-year randomized controlled trial that randomized 150 obese men and women to one of the following three planned isocaloric, normocaloric eating patterns (all with 17 energy percent (E%) protein): 1) A semi-whole-grain flour-based diet with 45 E% carbohydrates, in line with official dietary recommendations, 2) a diet with 45 E% carbohydrates based on minimally processed whole foods, and 3) a 12 E% carbohydrate diet based on minimally processed whole foods.

Main content

The primary outcome measure in the study is change in intra-abdominal ("visceral") fat mass measured by computed tomograpy (CT) imaging. Visceral fat mass strongly correlates with risk of common diseases such as type 2 diabetes, cardiovascular disease and cancer. Secondary outcome measures include postprandial levels of insulin and lipids, to determine whether different diets produce different metabolic adaptations and hence different responses to the same meal. Postprandial responses can indicate risk of type 2 diabetes and cardiovascular disease. Another outcome measure is gut microbiota composition and function, which may help to explain the hypothesized different metabolic responses to the diets, and psychological and social determinants of fat loss and/or compliance.

 

The trial started on January 15 2018, and the 6 month visit was completed in the end of August. The trial is registered at ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03401970