Low-Fat Vegan Diet Versus a Mediterranean Diet on Body Weight
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03698955|
Recruitment Status : Active, not recruiting
First Posted : October 8, 2018
Last Update Posted : March 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity Insulin Resistance||Other: Plant-based diet Other: Mediterranean Diet||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Cross-Over Trial on the Effects of a Low-Fat Vegan Diet Versus a Mediterranean Diet on Body Weight|
|Actual Study Start Date :||October 22, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Active Comparator: Plant-based diet
The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.
Other: Plant-based diet
Weekly instructions will be given to the participants in the intervention group about following the vegan diet.
Other Name: Vegan diet
Active Comparator: Mediterranean diet
The diet group will be asked to follow a Mediterranean diet for 16 weeks.
Other: Mediterranean Diet
Weekly instructions will be given to the participants in the intervention group about following the Mediterranean diet.
- Body weight [ Time Frame: Change in body weight from Baseline at 4 months ]Body weight will be assessed at the baseline and at the completion of both interventions.
- Plasma lipids [ Time Frame: Change in plasma cholesterol, triglycerides, and HbA1c from Baseline at 4 months ]Plasma cholesterol, triglycerides, and HbA1c will be measured in a fasting state.
- Insulin sensitivity [ Time Frame: Change in insulin sensitivity from Baseline at 4 months ]Insulin sensitivity will be assessed by the HOMA index.
- Metabolism [ Time Frame: Changes in metabolism from Baseline at 4 months ]
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.
- Levels of Advanced Glycosylation Endproducts (AGEs) [ Time Frame: Change in Advanced Glycosylation Endproducts (AGEs) from Baseline at 4 months ]An AGE reader will be used to measure the Levels of the AGEs in the skin
- Endothelial function [ Time Frame: Change in Endothelial function from Baseline at 4 months ]Endothelial function will be measured using the EndoPAT.
- Microbiome analysis [ Time Frame: Change in Microbiome from Baseline at 4 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698955
|United States, District of Columbia|
|Physicians Committee for Responsible Medicine|
|Washington, District of Columbia, United States, 20016|
|Principal Investigator:||Neal Barnard||Physicians Committee for Responsible Medicine|