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

Physicians Committee for Responsible Medicine

Status

Completed

Conditions

Overweight

Insulin Resistance

Obesity

Treatments

Other: Mediterranean Diet

Other: Plant-based diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03698955

Pro00029777

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No 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