Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs
Recruiting · NCT06395246 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut Investigacio Sanitaria Pere Virgili
View the official record on ClinicalTrials.gov →Interventions studied
Active Comparator: Continuous calorie restrictioneTRE
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- Hospital Universitario de Tarragona Juan XXIII - Tarragona, Tarragona, Spain