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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03698955
Other study ID # Pro00029777
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2018
Est. completion date November 13, 2019

Study information

Verified date February 2024
Source Physicians Committee for Responsible Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date November 13, 2019
Est. primary completion date November 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Men and women age =18 years of age - Body mass index 28-40 kg/m2 Exclusion Criteria: - Diabetes mellitus type 1, history of any endocrine condition that would affect body weight, such as thyroid disease, pituitary abnormality, or Cushing's syndrome - Smoking during the past six months - Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use - Use of recreational drugs in the past 6 months - Use within the preceding six months of medications that affect appetite or body weight, such as estrogens or other hormones, thyroid medications (unstable dose within the preceding 6 months), systemic steroids, antidepressants (tricyclics, MAOIs, SSRIs), antipsychotics, lithium, anticonvulsants, appetite suppressants or other weight-loss drugs, herbs for weight loss or mood, St. John's wort, ephedra, beta blockers - Pregnancy or intention to become pregnant during the study period, as verified by self--- - Unstable medical or psychiatric illness - Evidence of an eating disorder - Likely to be disruptive in group sessions - Already following a low-fat vegan diet or Mediterranean diet - Lack of English fluency - Inability to maintain current medication regimen - Inability or unwillingness to participate in all components of the study - Intention to follow another weight-loss method during the trial

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Plant-based diet
Weekly instructions will be given to the participants in the intervention group about following the vegan diet.
Mediterranean Diet
Weekly instructions will be given to the participants in the intervention group about following the Mediterranean diet.

Locations

Country Name City State
United States Physicians Committee for Responsible Medicine Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight Body weight will be assessed at the baseline and at the completion of both interventions. Change in body weight from Baseline at 4 months
Primary Plasma lipids Plasma cholesterol, triglycerides, and HbA1c will be measured in a fasting state. Change in plasma cholesterol, triglycerides, and HbA1c from Baseline at 4 months
Primary Insulin sensitivity Insulin sensitivity will be assessed by the HOMA index. Change in insulin sensitivity from Baseline at 4 months
Primary 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.
Changes in metabolism from Baseline at 4 months
Secondary Levels of Advanced Glycosylation Endproducts (AGEs) An AGE reader will be used to measure the Levels of the AGEs in the skin Change in Advanced Glycosylation Endproducts (AGEs) from Baseline at 4 months
Secondary Endothelial function Endothelial function will be measured using the EndoPAT. Change in Endothelial function from Baseline at 4 months
Secondary 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. Change in Microbiome from Baseline at 4 months
Secondary Dietary Advanced Glycation End Products (AGEs) Explore the effectiveness of a vegan diet in reducing dietary AGEs. 16 weeks
Secondary PDI, hPDI, uPDI Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss. 16 weeks
Secondary Ultraprocessed foods The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks. 16 weeks
Secondary 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. 16 weeks
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