Impact of Dietary Interventions on Mitochondrial Function and Gut Microbiota in Obesity
Metabolic Impact on the Mitochondria-gut Microbiota Axis of Failure to Follow Restrictive Dietary Interventions in Subjects Living With Obesity
This study is testing whether different diets like calorie restriction, intermittent fasting, and a ketogenic diet can improve health and gut bacteria in people with obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Mexico City, Tlalpan and 1 other locations) |
| Trial ID | NCT06782009 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of three different dietary interventions—calorie restriction, intermittent fasting, and a ketogenic diet—on mitochondrial function and gut microbiota in individuals living with obesity. Participants, aged 18 and older with a BMI of 30 or higher, will be randomly assigned to one of the dietary groups for an 8-week intervention, followed by a 24-week follow-up period. The study aims to monitor metabolic changes and the impact of dietary adherence on health outcomes, particularly focusing on the relationship between diet, mitochondrial health, and inflammation. The findings could provide insights into effective dietary strategies for managing obesity.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a body mass index of 30 kg/m2 or higher.
Not a fit: Patients with diabetes, high blood pressure, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary strategies that enhance mitochondrial function and gut health in obese patients.
How similar studies have performed: Other studies have shown promising results with dietary interventions in obesity management, suggesting that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female. * Adults \>18 years of age. * BMI ≥ 30 kg/m2 Exclusion Criteria: * Patients with any type of diabetes. * Patients with high blood pressure. * Patients with acquired diseases secondarily producing obesity and diabetes. * Patients who have suffered a cardiovascular event. * Patients who at the screening visit presented glucose values greater than 126 mg/dL, triglycerides greater than 350 mg/dL, cholesterol greater than 300mg/dL and/or creatinine greater than 1.2 mg/dL in men and greater than 1 mg/dL in women. * Patients with gastrointestinal diseases. * Weight loss \> 3 kg in the last 3 months. * Catabolic diseases such as cancer and acquired immunodeficiency syndrome. * Pregnancy status. * Positive smoking. * History of major surgery requiring general or regional anesthesia, respiratory support, and involving a recovery time longer than 2 weeks, such as surgeries of the abdomen (bowel resection), chest, head, and neck. * Diagnosis of Anxiety and Depression as Determined by the HADS Scale * Drug treatment: * Antihypertensive drugs or treatment * Treatment with hypoglycemic agents or insulin and antidiabetic drugs. * Treatment with statins, fibrates or other drugs to control dyslipidemia. * Use of antibiotics in the three months prior to the study. * Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy. * Anorexigenic or that accelerate weight loss such as sibutramine or orlistat. * Supplements with any of the functional foods used in the study. * Probiotic, prebiotic or symbiotic supplements.
Where this trial is running
Mexico City, Tlalpan and 1 other locations
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — Mexico City, Tlalpan, Mexico (Not_yet_recruiting)
- Departamento de Fisiología de la Nutrición. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán — Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Laura A Velazquez Villegas, PhD — Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study coordinator: Laura A Velazquez Villegas, PhD
- Email: laura.velazquezv@incmnsz.mx
- Phone: 5554870900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.