Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Recruiting · NCT06959043 · Interventional (participants receive a specific treatment) · Lead sponsor: Maria Elizabeth Rossi da Silva
View the official record on ClinicalTrials.gov →Interventions studied
Placebo AdministrationProbiotic Supplementation
What this trial is about
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.
Who can take part
Age range
45 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Universidade de São Paulo (USP) - São Paulo, São Paulo, Brazil