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RECRUITING

NCT05706155

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

Sponsor: Hospital de Clinicas de Porto Alegre

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

146

Start Date

2022-11-01

Completion Date

2027-12-30

Last Updated

2026-01-29

Healthy Volunteers

Conditions

Type 2 Diabetes Overweight Obesity

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.

Inclusion Criteria: * 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); * Use of any hypoglycemic and insulin; * Stable weight (maximum variation of approximately 5%) for at least 12 weeks before screening; * Not having undergone dietary intervention in the last 6 months; * Have the ability to understand and be able to adhere to intervention proposals; * Able and willing to provide an informed consent form for written and to comply with the requirements of the study protocol; Exclusion Criteria: * 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; * Grade III or IV heart failure * Active or progressive neurodegenerative disease; * Prior stroke that has caused sequelae; * Use of medications that affect glucose metabolism (e.g. corticosteroids or immunosuppressants) or cause weight loss; * Chronic treatment with oral or parenteral corticosteroids (\>7 days consecutive treatment) within 4 weeks prior to screening; * Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion, liraglutide, semaglutide) within the last 12 weeks before screening; * Treatment with thyroid hormone that was not maintained at a stable dose in last 12 weeks before screening; * History of active substance abuse (including alcohol) within the last year; * Thyroid Stimulating Hormone (TSH) outside the normal range; * Fasting triglycerides ≥ 600 mg/dL; * Tumor diagnosed and/or treated (except basal cell skin cancer, carcinoma in situ of the cervix, or prostate cancer in situ) within the last 5 years; * Severe psychiatric illness; * Predisposition or diagnosis of eating disorders; * Women who are pregnant, intend to become pregnant during the study period, or who are currently breastfeeding; * Hyperglycemia characterized by acute symptoms: polyuria, polydipsia and/or weight loss in the last 3 months; * Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma; * Potentially unreliable patients and those deemed by the investigator to be unsuitable for the study; * Night workers who work after 10pm; * Being on a vegetarian, vegan or flexitarian diet at the time of recruitment; * Having undergone bariatric surgery; * Carriers of the human immunodeficiency virus (HIV); * Any other medical condition/disorder that the investigators consider that are likely to: interfere with the patient's ability to complete the entire study period or participate in study activities; * Participants who require any treatment that could affect the interpretation, reliability or safety of data during the study intervention.

Locations (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil