Metabolic Impact on the Mitochondria-gut Microbiota Axis of Failure to Follow Restrictive Dietary Interventions in Subjects Living With Obesity

Launched by INSTITUTO NACIONAL DE CIENCIAS MEDICAS Y NUTRICION SALVADOR ZUBIRAN · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how not sticking to restrictive diets affects the body, particularly looking at the health of mitochondria (which are the energy powerhouses in our cells) and the gut microbiota (the community of bacteria in our intestines). The researchers want to understand how changes in diet and eating habits can lead to inflammation and other health issues in people living with obesity. Participants will be randomly assigned to one of three different dietary plans for eight weeks, and then they will be followed up for several months to monitor various health markers, including weight, energy usage, and gut bacteria composition.

To participate in this study, individuals must be over 18 years old and have a body mass index (BMI) of 30 or higher, indicating obesity. However, people with certain health conditions, like diabetes or high blood pressure, or those who have recently lost a significant amount of weight, cannot join. Participants can expect regular check-ins and health assessments during the trial, which could help provide insights into the effects of diet on overall health and well-being. This study is important because it aims to shed light on why many people struggle to maintain dietary changes and how that impacts their health over time.

Gender

ALL

Eligibility 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.