Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Brazil
Universidade de São Paulo (USP)
RECRUITING
São Paulo
Contact Information
Primary
Maria E. R. Silva, MD, PhD
mbeth@usp.br
+55 11 3061-7258
Backup
Edna C. Vieira, Master of Science in Nutrition
ednavieira@gmail.com
+55 11 98795-1544
Time Frame
Start Date: 2022-11-22
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Strict Vegetarian Diet, Regular Physical Exercise, and Placebo Administration
Participants in this group will follow a strict vegetarian diet (SVD) combined with regular physical exercise (RPE) for four weeks. The diet will consist of plant-based foods rich in fiber and bioactive compounds, with a controlled macronutrient distribution. Physical activity will include structured aerobic and resistance exercises supervised by a physical educator. Instead of probiotic supplementation, participants will receive a placebo administered in the same manner as the probiotic group to ensure blinding.
Experimental: Strict Vegetarian Diet, Regular Physical Exercise, and Probiotic Supplementation
Participants in this group will receive the same strict vegetarian diet (SVD) and regular physical exercise (RPE) as Arm 1. In addition, they will take a probiotic supplement containing a combination of four different strains, administered twice daily for four weeks. This group aims to assess the potential additional metabolic benefits of probiotic supplementation in individuals with type 2 diabetes.
Related Therapeutic Areas
Sponsors
Leads: Maria Elizabeth Rossi da Silva
Collaborators: Probiotical Spa, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Clínica e Spa Vida Natural