Diet, Insulin Sensitivity, and Postprandial Metabolism — TEF  

Obesity Clinical Trial

Official title: A Randomized, Controlled Trial on Diet, Insulin Sensitivity, and Postprandial Metabolism

Status Completed

Clinical Trial Summary

This randomized, controlled trial aims to elucidate the mechanisms by which a plant-based dietary intervention causes weight loss. Using a low-fat, plant-based diet for 16 weeks, along with an untreated control for comparison, the study will measure changes in body weight, body composition, intramyocellular and/or intrahepatocellular lipid, and changes in association to body weight.

Clinical Trial Description

In a 16-week trial, overweight adults will be randomly assigned to two groups. Changes in body weight, body composition, intramyocellular and/or intrahepatocellular lipid, and changes in association to body weight will be measured among other outcomes. The Intervention Group will follow a low-fat, vegan diet and will receive weekly classes and support. The Control Group will be asked to follow a conventional control diet. This study conducts a pilot sub-study to test the hypothesis that changes in insulin sensitivity and beta-cell function observed in response to a diet intervention correlate with changes in intramyocellular and/or intrahepatocellular lipid. Another sub-study assesses the association between metabolic outcomes and gut microbiome. One additional sub-study is looking for associations between metabolic outcomes and endothelial function. ;

Related Conditions & MeSH terms

• Hypersensitivity
• Insulin Resistance
• Obesity
• Overweight

• NCT number: NCT02939638
• Study type: Interventional
• Source: Physicians Committee for Responsible Medicine
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Completion date: January 9, 2019