RecruitingNot ApplicableNCT06395246

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

Sponsor

Institut Investigacio Sanitaria Pere Virgili

Enrollment

60 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

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 Criteria10

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.

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Interventions

BEHAVIORALActive 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

BEHAVIORALeTRE

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