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Studies

Interventional Recruiting

NCT06959043 on ClinicalTrials.gov

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

  • Sponsor: Maria Elizabeth Rossi da Silva
  • Collaborators: Clínica e Spa Vida Natural, Probiotical Spa, CNPq - National Council for Scientific and Technological Development
  • Enrollment: 60 (Estimated)
  • Study start: 2022-11-22 (Actual)
  • Primary completion: 2025-08-01 (Estimated)
  • Study completion: 2026-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: This is a double-blind, placebo-controlled, randomized clinical trial. Patients will be informed about the type of therapy they will receive at the clinic, which includes a strict vegetarian diet and regular physical exercises, as well as the importance of adhering strictly to the prescribed instructions. A total of 60 patients will be recruited, with a maximum of six participants per four-week cycle. They will be randomized and allocated to the following treatment groups: Group 1: Strict vegetarian diet (SVD) + regular physical exercise (RPE) (n=30). Group 2: SVD + RPE + administration of a probiotic pool (n=30).
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)
  • Insulin Resistance
  • Inflamation
  • Gut Microbiomes

Intervention / Treatment

  • Dietary Supplement: Probiotic Supplementation
  • Dietary Supplement: Placebo Administration

Primary Outcome Measures

  • Change in Body Mass Index (BMI) (Baseline and 4 weeks post-intervention)
    Body mass index (BMI) will be calculated from height and weight (weight in kg / height in m²) to assess the impact of the intervention on overall body weight regulation. This outcome reflects metabolic improvement and lifestyle adherence. Unit of Measure: kg/m²
  • Change in Waist, Abdominal, and Hip Circumference (Baseline and 4 weeks post-intervention)
    Waist, abdominal, and hip circumferences will be measured using a standardized flexible tape method. These anthropometric parameters are indicators of central fat distribution and associated cardiometabolic risk. Measurements will follow WHO recommendations. Unit of Measure: cm
  • Change in Waist-to-Hip Ratio (WHR) (Baseline and 4 weeks post-intervention)
    Waist-to-hip ratio (WHR) will be calculated by dividing waist circumference by hip circumference. This index is used to evaluate body fat distribution and the risk of metabolic disorders, particularly central obesity, in individuals with T2DM. Unit of Measure: Ratio (unitless)
  • Change in Functional Aerobic Capacity (1-Mile Walk Test) (Baseline and 4 weeks post-intervention)
    Aerobic capacity will be assessed using the 1-Mile Walk Test. Participants will be instructed to walk one mile as fast as possible on a flat surface, and the time to completion will be recorded. The objective is to evaluate improvements in cardiovascular endurance following the intervention. Unit of Measure: Time in minutes
  • Change in Functional Mobility (Up and Go Test) (Baseline and 4 weeks post-intervention)
    Functional mobility will be assessed using the "Up and Go" test. Participants will be timed as they rise from a seated position, walk three meters, turn around, walk back to the chair, and sit down. The test is used to detect improvements in balance, mobility, and lower-limb function in response to the intervention. Unit of Measure: Time in seconds
  • Change in Fasting Blood Glucose (Baseline and 4 weeks post-intervention)
    Fasting plasma glucose will be measured after 8-12 hours of fasting by glucose-oxidase method to evaluate improvements in basal glycemic levels. The goal is to determine whether the intervention improves glucose homeostasis in patients with T2DM. Unit of Measure: mg/dL
  • Change in Postprandial Glucose Levels (Baseline and 4 weeks post-intervention)
    Two-hour postprandial glucose will be measured using capillary or venous blood samples by glucose-oxidase method after a standardized meal. The goal is to evaluate improvements in glycemic response to food intake due to the intervention. Unit of Measure: mg/dL
  • Change in Glycated Hemoglobin (HbA1c) (Baseline and 4 weeks post-intervention)
    Glycated hemoglobin (HbA1c) levels will be measured in venous blood samples using HPLC to assess long-term glycemic control. The main hypothesis is that the combined intervention of a plant-based diet, physical exercise, and probiotics will significantly reduce HbA1c levels compared to baseline. Unit of Measure: % HbA1c

Countries

Brazil

Locations and Investigators

  • Universidade de São Paulo (USP), São Paulo, Brazil (Recruiting)
    • Benicio T. S. Pereira, MD
    • Edna C. Vieira, Master of Science in Nutrition
    • Edna C. Vieira, Master of Science in Nutrition
    • Benício T. S. Pereira, MD
    • José J. Farias Neto, MD
    • Daniela T. Kanno, MD
    • Aritania S. Santos, MS, PhD
    • Samuel K. Shinjo, MS, PhD, Postdoc
    • Denise C. Paranagua-Vezozzo, MD, PhD
    • Maria A. Mendes, MS, PhD, Postdoc
    • Marisa Passarelli, MS, PhD, Postdoc
    • Lucas A. M. Franco, MS, PhD
    • Maria E. R. Silva, MD, MS, PhD (Principal Investigator)

Study Officials