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RECRUITING
NCT06959043
NA

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

Sponsor: Maria Elizabeth Rossi da Silva

View on ClinicalTrials.gov

Summary

The study evaluates the impact of a strict vegetarian diet combined with regular physical exercise and the use of probiotics on metabolic, inflammatory, and epigenetic parameters in patients with type 2 diabetes. It aims to determine the influence of these interventions on gut microbiota, glycemic control, body composition, insulin resistance, and quality of life.

Key Details

Gender

All

Age Range

45 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-11-22

Completion Date

2026-12

Last Updated

2025-05-18

Healthy Volunteers

No

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.

Locations (1)

Universidade de São Paulo (USP)

São Paulo, São Paulo, Brazil