This randomized, cross-over trial aims to assess changes in body weight, plasma lipids, insulin sensitivity, and postprandial metabolism with a low-fat, plant-based diet and a Mediterranean diet, both followed for 4 months.
In a 36-week cross-over trial, overweight adults will consume a low-fat vegan diet and a Mediterranean diet in two separate 16-week phases. Changes in body weight will be the primary dependent variable. In addition, plasma lipid concentrations, insulin sensitivity, and postprandial metabolism will also be assessed and changes over time will be compared between the two diets. Participants will be randomly assigned to start either a low-fat vegan diet or a Mediterranean diet for 16 weeks. Both groups will receive weekly classes and support, and will be asked to make no changes to their exercise patterns for the study period. After a 4-week washout period, participants will cross over to the second dietary intervention for another 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Weekly instructions will be given to the participants in the intervention group about following the vegan diet.
Weekly instructions will be given to the participants in the intervention group about following the Mediterranean diet.
Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, United States
Body weight
Body weight will be assessed at the baseline and at the completion of both interventions.
Time frame: Change in body weight from Baseline at 4 months
Plasma lipids
Plasma cholesterol, triglycerides, and HbA1c will be measured in a fasting state.
Time frame: Change in plasma cholesterol, triglycerides, and HbA1c from Baseline at 4 months
Insulin sensitivity
Insulin sensitivity will be assessed by the HOMA index.
Time frame: Change in insulin sensitivity from Baseline at 4 months
Metabolism
Participants will be asked to report to the laboratory within 60 minutes of waking and after a 12-hour fast. Following 30 minutes of quiet rest in a dimly lit room, pulse, respiratory rate, and body temperature will be measured. REE will be measured for 20 minutes through indirect calorimetry (Cosmed Quark RMR, Chicago, IL) utilizing a ventilated hood system. The laboratory temperature will be maintained at 23 degrees C throughout, and precautions will be taken to minimize any disturbances that could affect the metabolic rate. For premenopausal women, measures will be timed so as to occur in the luteal phase of the menstrual cycle. Postprandial metabolism will be measured for three hours after the standard meal.
Time frame: Changes in metabolism from Baseline at 4 months
Levels of Advanced Glycosylation Endproducts (AGEs)
An AGE reader will be used to measure the Levels of the AGEs in the skin
Time frame: Change in Advanced Glycosylation Endproducts (AGEs) from Baseline at 4 months
Endothelial function
Endothelial function will be measured using the EndoPAT.
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Time frame: Change in Endothelial function from Baseline at 4 months
Microbiome analysis
Microbiome analysis will be performed from participant-provided stool sample. Anticipated changes in the dietary intervention group include changes in the microbiome composition that correlate with changes in insulin sensitivity.
Time frame: Change in Microbiome from Baseline at 4 months
Dietary Advanced Glycation End Products (AGEs)
Explore the effectiveness of a vegan diet in reducing dietary AGEs.
Time frame: 16 weeks
PDI, hPDI, uPDI
Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss.
Time frame: 16 weeks
Ultraprocessed foods
The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks.
Time frame: 16 weeks
Carbon Footprint
The greenhouse gas emissions (GHGE) and cumulative energy demand (CED) will be assessed, using the database of Food Impacts on the Environment for Linking to Diets (dataFIELD) and What We Eat In America (WWEIA) database, at baseline and 16 weeks.
Time frame: 16 weeks
Food costs
Food costs will be assessed, using the U.S. Department of Agriculture Thrifty Food Plan, 2021, at baseline and 16 weeks.
Time frame: 16 weeks