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Low-Fat Vegan Diet Versus a Mediterranean Diet on Body Weight

Primary Purpose

Overweight, Obesity, Insulin Resistance

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Plant-based diet

Mediterranean Diet

About this trial

This is an interventional treatment trial for Overweight focused on measuring Plant-based diet, Mediterranean diet, Vegan diet, Metabolism, Insulin sensitivity, Cholesterol, Advanced glycation end-products

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Physicians Committee for Responsible Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Plant-based diet

Mediterranean diet

Arm Description

The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.

The diet group will be asked to follow a Mediterranean diet for 16 weeks.

Outcomes

Primary Outcome Measures

Body weight

Body weight will be assessed at the baseline and at the completion of both interventions.

Plasma lipids

Plasma cholesterol, triglycerides, and HbA1c will be measured in a fasting state.

Insulin sensitivity

Insulin sensitivity will be assessed by the HOMA index.

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.

Secondary Outcome Measures

Levels of Advanced Glycosylation Endproducts (AGEs)

An AGE reader will be used to measure the Levels of the AGEs in the skin

Endothelial function

Endothelial function will be measured using the EndoPAT.

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.

Full Information

NCT ID

NCT03698955

First Posted

October 3, 2018

Last Updated

February 18, 2020

Sponsor

Physicians Committee for Responsible Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03698955

Brief Title

Low-Fat Vegan Diet Versus a Mediterranean Diet on Body Weight

Official Title

A Randomized, Cross-Over Trial on the Effects of a Low-Fat Vegan Diet Versus a Mediterranean Diet on Body Weight

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

October 22, 2018 (Actual)

Primary Completion Date

November 13, 2019 (Actual)

Study Completion Date

November 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Physicians Committee for Responsible Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity, Insulin Resistance

Keywords

Plant-based diet, Mediterranean diet, Vegan diet, Metabolism, Insulin sensitivity, Cholesterol, Advanced glycation end-products

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Plant-based diet

Arm Type

Active Comparator

Arm Description

The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.

Arm Title

Mediterranean diet

Arm Type

Active Comparator

Arm Description

The diet group will be asked to follow a Mediterranean diet for 16 weeks.

Intervention Type

Other

Intervention Name(s)

Plant-based diet

Other Intervention Name(s)

Vegan diet

Intervention Description

Weekly instructions will be given to the participants in the intervention group about following the vegan diet.

Intervention Type

Other

Intervention Name(s)

Mediterranean Diet

Intervention Description

Weekly instructions will be given to the participants in the intervention group about following the Mediterranean diet.

Primary Outcome Measure Information:

Title

Body weight

Description

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

Title

Plasma lipids

Description

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

Title

Insulin sensitivity

Description

Insulin sensitivity will be assessed by the HOMA index.

Time Frame

Change in insulin sensitivity from Baseline at 4 months

Title

Metabolism

Description

Time Frame

Changes in metabolism from Baseline at 4 months

Secondary Outcome Measure Information:

Title

Levels of Advanced Glycosylation Endproducts (AGEs)

Description

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

Title

Endothelial function

Description

Endothelial function will be measured using the EndoPAT.

Time Frame

Change in Endothelial function from Baseline at 4 months

Title

Microbiome analysis

Description

Time Frame

Change in Microbiome from Baseline at 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neal Barnard

Organizational Affiliation

Physicians Committee for Responsible Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Physicians Committee for Responsible Medicine

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34330460

Citation

Kahleova H, McCann J, Alwarith J, Rembert E, Tura A, Holubkov R, Barnard ND. A plant-based diet in overweight adults in a 16-week randomized clinical trial: The role of dietary acid load. Clin Nutr ESPEN. 2021 Aug;44:150-158. doi: 10.1016/j.clnesp.2021.05.015. Epub 2021 May 29.

Results Reference

derived

PubMed Identifier

33544066

Citation

Barnard ND, Alwarith J, Rembert E, Brandon L, Nguyen M, Goergen A, Horne T, do Nascimento GF, Lakkadi K, Tura A, Holubkov R, Kahleova H. A Mediterranean Diet and Low-Fat Vegan Diet to Improve Body Weight and Cardiometabolic Risk Factors: A Randomized, Cross-over Trial. J Am Nutr Assoc. 2022 Feb;41(2):127-139. doi: 10.1080/07315724.2020.1869625. Epub 2021 Feb 5.

Results Reference

derived

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Low-Fat Vegan Diet Versus a Mediterranean Diet on Body Weight

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