Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorMaria Elizabeth Rossi da Silva
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic Supplementation
Dietary supplementParticipants 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.
Placebo Administration
Dietary supplementParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Strict Vegetarian Diet, Regular Physical Exercise, and Placebo AdministrationPlacebo comparator 1 intervention
Group B: Strict Vegetarian Diet, Regular Physical Exercise, and Probiotic SupplementationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Body Mass Index (BMI)
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
Time frame
Baseline and 4 weeks post-intervention2
Change in Waist, Abdominal, and Hip Circumference
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
Time frame
Baseline and 4 weeks post-intervention3
Change in Waist-to-Hip Ratio (WHR)
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)
Time frame
Baseline and 4 weeks post-intervention4
Change in Functional Aerobic Capacity (1-Mile Walk Test)
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
Time frame
Baseline and 4 weeks post-interventionSecondary outcomes
1
Change in Liver Enzymes (AST, ALT, GGT)
Serum levels of liver enzymes (AST, ALT, GGT) will be measured using automated enzymatic assays to evaluate liver function and detect possible hepatocellular injury or metabolic improvements after the intervention. Unit of Measure: U/L
Time frame
Baseline and 4 weeks post-intervention2
Change in Standard Lipid Profile
Serum levels of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides will be measured by enzymatic colorimetric assays. These parameters are essential for assessing cardiometabolic risk in patients with T2DM. Unit of Measure: mg/dL
Time frame
Baseline and 4 weeks post-intervention3
HDL Function and Lipid Profile
HDL function will be evaluated by measuring cholesterol efflux capacity in vitro using labeled macrophage assays. The result reflects HDL's ability to remove cholesterol from peripheral tissues, a key anti-atherogenic property. Unit of Measure: % cholesterol efflux
Time frame
Baseline and 4 weeks post-intervention4
Change in C-Reactive Protein (CRP) Levels
C-reactive protein (CRP), a marker of systemic low-grade inflammation and cardiovascular risk, will be measured in plasma using high-sensitivity Luminex assay. Unit of Measure: mg/L
Time frame
Baseline and 4 weeks post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maria Elizabeth Rossi da Silva
Lead sponsor
University of Sao Paulo General Hospital
Sponsor institution
Clínica e Spa Vida Natural
Collaborator
Probiotical S.p.A.
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Source ClinicalTrials.gov