RecruitingNot ApplicableNCT05706155

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

Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management: A Randomized Clinical Trial

Sponsor

Hospital de Clinicas de Porto Alegre

Enrollment

146 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Obesity Overweight Type 2 Diabetes

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether replacing some animal-based protein (like meat and dairy) with plant-based protein in the diet can help manage blood sugar levels in adults with Type 2 diabetes who are overweight or obese. **You may be eligible if...** - You are between 18 and 65 years old - You have Type 2 diabetes with an HbA1c (a blood sugar measure) between 7% and 11% - Your BMI is between 25 and 40 (overweight or obese) - You are currently taking diabetes medications (oral or insulin) - Your weight has been stable for at least 12 weeks before screening - You have not been on a specific dietary program in the last 6 months **You may NOT be eligible if...** - You have Type 1 diabetes - You have serious kidney, liver, or heart disease - You have had a stroke with lasting effects - You are taking steroids, immunosuppressants, or weight-loss medications - You have been on certain other medications that affect weight or blood sugar recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALControl 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.

BEHAVIORALPlant-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.