Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

Recruiting now · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT06395246

Run by

Institut Investigacio Sanitaria Pere Virgili

People needed

60

Starts

2024-05-20

Expected to finish

2025-12-20

Last updated by the study team

2024-10-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age between 18 and 70 years old.
• BMI ranges between 27 and 40 kg/ m2.
• Absence of underlying pathology in medical and physical examination, except for those related to excess weight.
• Signature of the informed consent for participation in the study.

You may not qualify if…

• Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease.
• Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma).
• Pregnancy and lactation.
• Vegetarians or subjects subjected to an irregular diet.
• Patients with severe eating disorders.
• Patients with clinical symptoms and signs of infection in the previous month.
• Patients with chronic anti-inflammatory steroid treatments and/or nonsteroidal anti-inflammatory drugs.
• Recent antibiotic treatment.
• Uncontrolled alcoholism or drug abuse.
• Rotating or nocturnal shift workers.

Where it is running

• Hospital Universitario de Tarragona Juan XXIII — Tarragona, Tarragona, Spain (enrolling)

Full record on ClinicalTrials.gov

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