Health TrialsbyHealthPanel

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

ConditionsType 2 DiabetesOverweightObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHospital de Clinicas de Porto Alegre

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 and ≤65 years old)

Diagnosis of Type 2 Diabetes;

Glycated hemoglobin from 7% to 11%;

Overweight or obesity (BMI ≥25 kg/m² and <40 kg/m²);

Disqualifiers

Type 1 diabetes mellitus;

Retinopathy with vision deficit that limits the activities proposed in the interventions;

Chronic kidney disease with estimated glomerular filtration < 30 mL/min per 1.73m²;

Liver failure, chronic viral hepatitis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control Diet

    Behavioral

    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.

  • Plant-based Diet

    Behavioral

    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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Glycated Hemoglobin

Difference between groups in glycated hemoglobin

Time frame
baseline, 12 and 24 weeks

Secondary outcomes

1

Glycemic Variability

For continuous glucose monitoring and assessment of glycemic variability, the FreeStyle Libre, ABBOTT® device will be used. FreeStyle Libre consists of a continuous glucose monitoring (SMCG) system. Glycemic variability will be assessed using time on target parameters of values between 70 and 180 mg/dL, time in hypoglycemia and time above target and coefficient of variability as measures of glycemic variability.

Time frame
baseline and 12 weeks
2

Changes in postprandial metabolism

Postprandial metabolism will be measured after the intake of liquid standard meal. Insulin secretion, insulin sensitivity and beta-cell function will be assessed by mathematical models

Time frame
baseline and 12 weeks
3

Changes in body composition

Fat-free mass and fat mass will be assessed by Bioelectrical Impedance (body composition analyzer tetrapolar InBody 370S, BiospaceCo. Ltd, Seoul, South Korea). Anthropometric measures include brachial, neck, waist, hip and calf circumferences, with participants wearing light clothing and barefoot.

Time frame
Monthly, up to 24 weeks
4

Changes in cardiometabolic outcomes

Lipid profile will include total cholesterol, HDL-c, LDL-c, triglycerides, apolipoprotein B, apolipoprotein a1 and lipoprotein (a).

Time frame
baseline and 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital de Clinicas de Porto Alegre

Lead sponsor

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Collaborator

Source ClinicalTrials.gov
Apply now