NCT02939638

Diet, Insulin Sensitivity, and Postprandial Metabolism

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Physicians Committee for Responsible Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Overweight
• Obesity
• Insulin Resistance

Interventions

Type	Name	Description
OTHER	Plant-based diet	Weekly instructions will be given to the participants in the intervention group about following vegan diet.
OTHER	Control Diet	Participants will be asked to continue their usual diets for the 16-week study period.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-12-01
• Completion: 2019-01-09
• First posted: 2016-10-20
• Last updated: 2023-07-19

Locations

1 site across 1 country: United States