Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management
140 patients around the world
Available in Brazil
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.