RECRUITINGINTERVENTIONAL

Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form for participation in the study. Who Should NOT Join This Trial: 1. Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease. 2. Systemic diseases with intrinsic inflammatory activity (autoimmune conditions (where your immune system attacks your own body)s 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

Active Comparator: Continuous calorie restriction

Individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention

BEHAVIORAL

eTRE

early (morning) time-restricted eating pluss individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention

Locations (1)

Hospital Universitario de Tarragona Juan XXIII

Tarragona, Tarragona, Spain