Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Maria Elizabeth Rossi da Silva
60 participants
Nov 22, 2022
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
Inclusion Criteria6
- Have a medical diagnosis of type 2 diabetes for a maximum of 5 years.
- Be omnivorous; Have a Body Mass Index (BMI) ≥ 25 kg/m2 and \< 40 kg/m2;
- Be between the ages of 45 and 70, both genders.
- Women should be in the postmenopausal stage;
- Use no more than three hypoglycemic medications in total;
- Have the availability for a four-week consecutive hospitalization at CSVN.
Exclusion Criteria6
- Be using insulin, anti-obesity medications, antibiotics, and/or probiotic supplements in the 2 months preceding data collection;
- Use of alcohol or tobacco;
- Have limited mobility and a previous diagnosis of cardiopulmonary diseases;
- Report current or previous (within the past two months) diarrhea during screening;
- Have liver or kidney failure and uncontrolled endocrine disorders (hypothyroidism, hypogonadism, and adrenal insufficiency);
- Have eating disorders or have undergone bariatric surgery.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT06959043