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Search / Trial NCT06395246

Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

Launched by INSTITUT INVESTIGACIO SANITARIA PERE VIRGILI · Apr 29, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Obesity Extracellular Vesicles Incretins Bile Acids Short Chain Fatty Acids Time Restricted Feeding Caloric Restriction Brown Fat

ClinConnect Summary

This clinical trial is exploring how two different dietary plans can help people with obesity improve their metabolism and overall health. The first plan is called Daily Caloric Restriction (DCR), where participants reduce their daily calorie intake. The second plan combines DCR with a method called Early Time-Restricted Feeding (eTRE), which involves eating during a specific time window each day. Researchers are particularly interested in how tiny particles in the bloodstream, called extracellular vesicles, play a role in communication between different organs in the body during this process.

To participate in this study, individuals should be between 18 and 70 years old and have a body mass index (BMI) between 27 and 40, which indicates obesity. They should also be generally healthy, without serious illnesses unrelated to obesity. Participants will sign an informed consent form and may expect guidance on following the dietary plans while contributing to important research. It's essential to note that people with certain health conditions, pregnant individuals, and those with specific dietary restrictions may not be eligible for this study.

Gender

ALL

Eligibility criteria

  • 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.

About Institut Investigacio Sanitaria Pere Virgili

Institut d'Investigació Sanitària Pere Virgili (IISPV) is a leading biomedical research institute based in Tarragona, Spain, dedicated to advancing health through innovative research and clinical trials. Affiliated with the University Rovira i Virgili and the Joan XXIII University Hospital, IISPV focuses on translating scientific discoveries into clinical applications to improve patient care. With a multidisciplinary team of researchers and clinicians, the institute emphasizes collaboration and excellence in various fields, including oncology, cardiovascular health, and infectious diseases. IISPV's commitment to fostering research innovation and enhancing healthcare outcomes positions it as a key player in the global scientific community.

Locations

Tarragona, , Spain

Patients applied

0 patients applied

Trial Officials

Juan José Vendrell Ortega, Professor

Principal Investigator

Instituto de Investigación Sanitaria Pere Virgili (IISPV)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported