Suspended

Low-Fat, Plant-Based Diet vs. Portion-Controlled Diet for Intracellular Lipid Reduction in Type 2 Diabetes

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Study Aim

This study compares the effects of a low-fat, plant-based diet and a portion-controlled diet on reducing intracellular lipids in individuals with type 2 diabetes, by measuring C-peptide concentration, glucose levels, hepatocellular and intramyocellular lipid content, insulin sensitivity, and rate of glycemic control.

What is being tested

Dietary intervention

Behavioral
Who is being recruted

Diabetes Mellitus+5

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorPhysicians Committee for Responsible Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on Type 2 diabetes, a condition where the body's insulin production doesn't meet its needs, often linked to excess fat in liver and muscle cells. The research aims to compare the effects of two dietary interventions: a low-fat, plant-based diet and a portion-controlled diet that aligns with current American Diabetes Association guidelines. The goal is to see how these diets impact fat content in liver and muscle cells in adults with Type 2 diabetes. This study is important as it could provide insights into dietary strategies for improving insulin sensitivity and managing Type 2 diabetes. Participants with Type 2 diabetes will be randomly assigned to start with either the plant-based or the portion-controlled diet for 22 weeks, then switch to the other diet for another 22 weeks. Before and after each diet period, researchers will measure fat content in muscle and liver cells. They will also evaluate insulin sensitivity and blood sugar control. The study anticipates that both diets will reduce fat content in these cells, leading to improved insulin sensitivity and blood sugar control. However, it is hypothesized that the low-fat, plant-based diet will result in greater changes in cellular fat content compared to the portion-controlled diet.

Official TitlePhysicians Committee for Responsible Medicine, A Randomized, Crossover Trial of the Effect of a Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes
NCT04088981
Principal SponsorPhysicians Committee for Responsible Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHyperinsulinismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

Inclusion criteria are as follows: 1. Men and women with type 2 diabetes treated by diet and/or oral hypoglycemic agents other that sulfonylureas 2. Age ≥18 years 3. Body mass index 26-40 kg/m2 4. Medications (antidiabetic, antihypertensive, and lipid-lowering) have been stable for the past 3 months 5. HbA1c between 6-10.5% (42-88 mmol/mol) Exclusion criteria are as follows: 1. Diabetes mellitus, type 1 and/or treatment with insulin or sulfonylureas 2. Metal implants, such as a cardiac pacemaker or an aneurysm clip 3. History of any endocrine condition that would affect body weight, such as thyroid disease, pituitary abnormality, or Cushing's syndrome 4. Smoking during the past six months 5. 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 6. Use of recreational drugs in the past 6 months 7. 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, 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 8. Pregnancy or intention to become pregnant during the study period 9. Unstable medical or psychiatric illness 10. Evidence of an eating disorder 11. Likely to be disruptive in group sessions 12. Already following a low-fat, vegan diet 13. Lack of English fluency 14. Inability to maintain current medication regimen 15. Inability or unwillingness to participate in all components of the study 16. Intention to follow another weight-loss method during the trial Participants will also review and complete the Yale MRI Safety Questionnaire to determine eligibility for the study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
For a 22-week period, participants will be asked to follow a low-fat vegan diet which consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products and added oils will be excluded. In choosing grain products and starchy vegetables (e.g., bread, potatoes), participants will be encouraged to select those retaining their natural fiber and having a glycemic index \<70, using tables standardized to a value of 100 for glucose.

Group II

Active Comparator
For a 22-week period, participants will be asked to follow a portion-controlled diet which will include individualized diet plans that reduce daily energy intake by 500 kcal for overweight participants, and keep carbohydrate intake reasonably stable over time. It will derive 50% of total energy from carbohydrates, 20% from protein, and less than 30% from fat (≤7% saturated fat), with less than 200 mg/day of cholesterol/day.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Physicians Committee for Responsible Medicine

Washington D.C., United StatesOpen Physicians Committee for Responsible Medicine in Google Maps
SuspendedOne Study Center