The Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes
NCT06106035 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2026-01-20
Summary
The goal of this 16-week clinical trial is to assess the health benefits of a low-fat vegan diet on insulin sensitivity and glycemic control in type 2 diabetes. Participants will receive at no cost, study-related weekly nutrition education classes and one-on-one consultation with a registered dietitian.
Conditions
- Diabetes Mellitus, Type 2
- Diabetes Mellitus Type 2 in Obese
Interventions
- BEHAVIORAL
-
low-fat vegan diet
The intervention diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Participants will also be guided to favor foods with a low glycemic index. Animal products and added oils will be excluded. The diet is designed to derive approximately 10% of energy from fat, approximately 10-15% of energy from protein, and the remainder from mostly complex carbohydrates. The diet will also provide approximately 40 g of fiber per day.
Sponsors & Collaborators
-
Yale University
collaborator OTHER -
Physicians Committee for Responsible Medicine
lead OTHER
Principal Investigators
-
Hana Kahleova, MD, PhD · Physicians Committee for Responsible Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-13
- Primary Completion
- 2025-11-28
- Completion
- 2025-11-28
Countries
- United States
Study Locations
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