Evaluating dietary protocols for obesity management

The Usefulness of Circulating Microvesicles (host and Bacterial) in Regulating Metabolic Homeostasis in Obesity Randomized Study of Parallel Arms in Obese Patients Undergoing Caloric Restriction Diet Vs. Early Time-restricted Eating

This study is testing two different eating plans to see which one helps people who are not severely obese lose weight and improve their metabolism over 12 weeks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Institut Investigacio Sanitaria Pere Virgili (other)
• Locations: 1 site (Tarragona, Tarragona)
• Trial ID: NCT06395246 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of two dietary protocols, Daily Caloric Restriction (DCR) and Early Time-Restricted Feeding combined with DCR (eTRE), on metabolic homeostasis in non-morbidly obese individuals. It will evaluate weight loss, metabolic benefits, and the role of circulating extracellular vesicles (EVs) in inter-organ communication. The study will involve a randomized parallel-arm design with 40 participants, who will be monitored for clinical variables, adherence, and metabolic markers over a 12-week period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a BMI between 27 and 40 kg/m² and no serious underlying health conditions.

Not a fit: Patients with serious systemic diseases, autoimmune conditions, or those with severe eating disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new dietary strategies for effective weight management and metabolic health in obese patients.

How similar studies have performed: Other studies have shown promising results with dietary interventions for obesity, suggesting that this approach may be effective.

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.

Where this trial is running

Tarragona, Tarragona

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

Study contacts

• Principal investigator: Juan José Vendrell Ortega, Professor — Instituto de Investigación Sanitaria Pere Virgili (IISPV)
• Study coordinator: Juan José Vendrell Ortega, Professor

Conditions: Obesity, obesity, extracellular vesicles, incretins, bile acids, short-chain fatty acids, time-restricted feeding, caloric restriction