Status:
COMPLETED
Effect of Dietary Restrictions and Ketogenic Diet on Mitochondrial Function and Gut Microbiota in Subjects With Obesity
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The benefits of nutritional interventions with dietary restrictions are associated with improvement and preservation of mitochondrial function. Evidence suggests that dietary restrictions, including m...
Detailed Description
The study consists of an open-label randomized controlled clinical trial. Selected subjects will be randomized to one of 4 dietary intervention groups for 1 month with energy intake according to the r...
Eligibility Criteria
Inclusion
- Male and female.
- Adults between 18 and 60 years of age.
- BMI ≥ 30 and ≤ 50 kg/m2.
Exclusion
- 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 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.
- 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.
Key Trial Info
Start Date :
July 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05200468
Start Date
July 28 2022
End Date
March 27 2023
Last Update
December 7 2023
Active Locations (1)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 14080