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Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

RecruitingNAAges 18 Years - 70 YearsAllInstitut Investigacio Sanitaria Pere Virgili
NCT06395246 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The main aim of the present study is to evaluate the effectiveness of two dietary protocols: Daily Caloric Restriction (DCR) and Early Time-Restricted Feeding + DCR (eTRE) on metabolic homeostasis and the influence of circulating extracellular vesicles (EVs) as inter-organ communication elements in obese patients.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. age between 18 and 70 years old. 2. BMI ranges between 27 and 40 kg/ m2. 3. Absence of underlying pathology in medical and physical examination, except for those related to excess weight. 4. Signature of the informed consent for participation in the study. Exclusion Criteria: 1. Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease. 2. Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma). 3. Pregnancy and lactation. 4. Vegetarians or subjects subjected to an irregular diet. 5. Patients with severe eating disorders. 6. Patients with clinical symptoms and signs of infection in the previous month. 7. Patients with chronic anti-inflammatory steroid treatments and/or nonsteroidal anti-inflammatory drugs. 8. Recent antibiotic treatment. 9. Uncontrolled alcoholism or drug abuse. 10. Rotating or nocturnal shift workers.
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What it tests

  • Active Comparator: Continuous calorie restriction
  • eTRE
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Where

1 site
Hospital Universitario de Tarragona Juan XXIII
Tarragona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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