Interventional Recruiting
NCT05706155 on ClinicalTrials.gov
Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management
Official title: Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management: A Randomized Clinical Trial
- Sponsor: Hospital de Clínicas de Porto Alegre
- Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Enrollment: 146 (Estimated)
- Study start: 2022-11-01 (Actual)
- Primary completion: 2027-12-30 (Estimated)
- Study completion: 2027-12-30 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: This is a single center and open label randomized controlled trial, in which participants will be assigned to one of the two different dietary interventions
- Masking: Single (Outcomes Assessor)
- PrimaryPurpose: Treatment
Brief Summary
The goal of this clinical trial is to examine the effect plant-based diet, with a partial replacement of animal protein by plant protein, in blood sugar levels and other health risks of people with type 2 diabetes and excessive weight. The plant-based diet will be compared to a standard healthy diet according to guidelines for people with diabetes. Participants will follow a plant-based or a standard healthy diet for 24 weeks and will maintain their habitual levels of physical activity.
Conditions
- Type 2 Diabetes
- Overweight
- Obesity
Intervention / Treatment
- Behavioral: Control Diet
- Behavioral: Plant-based Diet
Primary Outcome Measures
-
Change in Glycated Hemoglobin
(baseline, 12 and 24 weeks)
Difference between groups in glycated hemoglobin
Countries
Brazil
Locations and Investigators
- Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (Recruiting)
Study Officials
- Fernando Gerchman, PhD (Principal Investigator) — Hospital de Clínicas de Porto Alegre