Diet, Insulin Sensitivity, and Postprandial Metabolism

Completed · Not applicable

Conditions studied: Overweight, Obesity, Insulin Resistance

In brief

This randomized, controlled trial aims to elucidate the mechanisms by which a plant-based dietary intervention causes weight loss. Using a low-fat, plant-based diet for 16 weeks, along with an untreated control for comparison, the study will measure changes in body weight, body composition, intramyocellular and/or intrahepatocellular lipid, and changes in association to body weight.

Key facts

Study ID

NCT02939638

Run by

Physicians Committee for Responsible Medicine

People needed

220

Starts

2016-10-01

Expected to finish

2019-01-09

Last updated by the study team

2023-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women age ≥18 years of age
• Body mass index 28-40 kg/m2

You may not qualify if…

• Diabetes mellitus, type 1 or 2, history of diabetes mellitus or 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, systemic steroids, antidepressants (tricyclics, monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (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
• Unstable medical or psychiatric illness
• Evidence of an eating disorder
• Likely to be disruptive in group sessions
• Already following a low-fat, vegan 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

Where it is running

• Physicians Committee for Responsible Medicine — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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