RecruitingNot ApplicableNCT06959043

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


Sponsor

Maria Elizabeth Rossi da Silva

Enrollment

60 participants

Start Date

Nov 22, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 45 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a plant-based diet combined with structured physical exercise can help manage — and potentially reverse — type 2 diabetes by improving blood sugar control and insulin sensitivity. It is a lifestyle intervention study, not a drug trial. **You may be eligible if...** - You are between 45 and 70 years old (any gender) - You have had type 2 diabetes for no more than 5 years - You currently eat meat and other animal products (omnivorous diet) - Your BMI is between 25 and 40 (overweight or obese range) - Women must be postmenopausal - You take no more than three diabetes medications **You may NOT be eligible if...** - You already follow a vegetarian or plant-based diet - You have had diabetes for more than 5 years - You are on insulin therapy - You have cardiovascular disease, kidney disease, or other significant health conditions - You are premenopausal (for women) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProbiotic 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_SUPPLEMENTPlacebo 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

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NCT06959043


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