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Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management

NCT05706155 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-01-29

No results posted yet for this study

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

Interventions

BEHAVIORAL

Control Diet

Hypocaloric diet to achieve a 5% weight loss with macronutrient distribution according to current guidelines for T2D: 50% of energy from carbohydrates, prioritizing those with low glycemic index; 30% from total fats and a maximum of 10% from saturated fats; 20% of energy from proteins, 15% from animal sources and 5% from plant sources. Participants will also receive printed and validated educational material, with recommendations for healthy eating, and will be instructed to maintain their habitual physical activity level.

BEHAVIORAL

Plant-based Diet

Hypocaloric diet to achieve a 5% weight loss. The dietary prescription was adapted from the Eat-Lancet Commission report to Brazilian population culture, with 50% of energy from carbohydrates, prioritizing those with a low glycemic index; 30% from total fats and a maximum of 5% from saturated fats; 20% from proteins, 5% from animal sources and 15% from plant sources. Participants in this group will receive printed and validated support material with recommendations for a healthy and plant-based eating, and will be instructed to maintain their habitual physical activity level.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Fernando Gerchman, PhD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05706155 on ClinicalTrials.gov