Switching from animal to plant-based protein for managing type 2 diabetes

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

This study is testing if switching from animal protein to a plant-based diet can help people with type 2 diabetes and extra weight manage their blood sugar better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hospital de Clinicas de Porto Alegre (Academic / other)
• Locations: 1 site (Porto Alegre, Rio Grande do Sul)
• Trial ID: NCT05706155 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a plant-based diet that partially replaces animal protein on blood sugar levels and health risks in individuals with type 2 diabetes and excess weight. Participants will be randomly assigned to either a control diet based on current diabetes guidelines or a plant-based diet for 24 weeks, while maintaining their usual physical activity levels. Both groups will receive nutritional and medical support, and their adherence will be monitored through monthly phone calls. Clinical, laboratory, and nutritional evaluations will be conducted at the beginning and end of the study to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of type 2 diabetes, overweight or obesity, and stable weight.

Not a fit: Patients with type 1 diabetes, severe chronic conditions, or those who have undergone recent dietary interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve blood sugar control and overall health for patients with type 2 diabetes.

How similar studies have performed: Other studies have shown promising results with plant-based diets in managing diabetes, indicating potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Porto Alegre, Rio Grande do Sul

• Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)

Study contacts

• Principal investigator: Fernando Gerchman, PhD — Hospital de Clínicas de Porto Alegre
• Study coordinator: Fernando Gerchman, PhD

Conditions Type 2 Diabetes; Overweight; Obesity; Diabetes Mellitus; Plant-based Diet; Insulin Resistance