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
Qualifiers
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
Treatments tested in this trial
- Probiotic Supplementation
- Placebo Administration
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
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