Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 22, 2022

Primary Completion Date

August 31, 2025

Study Completion Date

December 31, 2026

Conditions
Type 2 Diabetes Mellitus (T2DM)Insulin ResistanceInflamationGut Microbiomes
Interventions
DIETARY_SUPPLEMENT

Probiotic Supplementation

Participants will follow the same strict vegetarian diet and regular physical exercise as in Intervention 1. Additionally, they will receive a probiotic supplement, taken twice daily for four weeks. This aims to evaluate the metabolic impact of probiotics in type 2 diabetes.

DIETARY_SUPPLEMENT

Placebo Administration

Participants will follow a strictly plant-based diet rich in fiber and bioactive compounds, with controlled macronutrient distribution. Regular physical exercise includes supervised aerobic and resistance training sessions. The intervention lasts four weeks. Instead of probiotic supplementation, participants will receive a placebo, administered in the same manner as the probiotic group to maintain blinding.

Trial Locations (1)

01246-903

RECRUITING

Universidade de São Paulo (USP), São Paulo

All Listed Sponsors
collaborator

Clínica e Spa Vida Natural

UNKNOWN

collaborator

Probiotical Spa

UNKNOWN

collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

lead

Maria Elizabeth Rossi da Silva

OTHER