Tests a plant-based diet for type 2 diabetes and excess weight
Compares a diet with some animal protein swapped for plant protein against a standard diet.
Plain-language title generated from the registry record
Registry title: Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management
Key facts
- Where
- Porto Alegre, BrazilSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05706155, who can take part
Where in Brazil
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital de Clinicas de Porto Alegre
- Trial code
- NCT05706155
- Record updated
- 29 January 2026
- Original description
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.Read full original descriptionShow less
Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management: A Randomized Clinical 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.
Inclusion: 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: Prior stroke that has caused sequelae; 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; Having undergone bariatric surgery; Type 1 diabetes mellitus; 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; History of active substance abuse (including alcohol) within the last year; 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; Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma; 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; Use of medications that affect glucose metabolism (e.g. corticosteroids or immunosuppressants) or cause weight loss; Fasting triglycerides ≥ 600 mg/dL; Retinopathy with vision deficit that limits the activities proposed in the interventions; Thyroid Stimulating Hormone (TSH) outside the normal range; 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; 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; Participants who require any treatment that could affect the interpretation, reliability or safety of data during the study intervention.