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

Obesity Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a single center, open label, parallel and randomized clinical trial. Subjects with type 2 diabetes (T2D) and excessive weight will be recruited through advertisement on the web page of Hospital de Clínicas de Porto Alegre (HCPA), local newspaper, television and social media, or referred by a doctor or nutritionist, from external to HCPA services. Patients will be also screened through electronic records of HCPA's clinics. After screening and selection according to inclusion criteria, participants will undergo a clinical, laboratory and nutritional evaluation following a standard assessment protocol. After all baseline assessments, they will be randomly allocated to one of the following interventions for 24 weeks: (1) Control diet (CDG): hypocaloric diet according to current guidelines for T2D or (2) Plant-based diet (PBG): hypocaloric diet with partial replacement of animal protein by plant protein. Both groups will have caloric targets calculated to achieve a 5% weight loss during the 6 months of study, will have the same macronutrient distribution on the diet and will receive the same nutritional and medical support. Telephone calls will be performed monthly for adherence evaluation. At the end of 12 and 24 weeks of intervention, all patients will be submitted to the same clinical, laboratory and nutrition exams applied at baseline. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Type 2 Diabetes

• NCT number: NCT05706155
• Study type: Interventional
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Fernando Gerchman, PhD
• Phone: +555133596246
• Email: fgerchman@hcpa.edu.br
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Completion date: October 1, 2024