Clinical trial

Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

Recruiting now · Not applicable · 1 countries · Registry ID NCT06395246

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry 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.

Treatments and study arms

Active Comparator: Continuous calorie restriction

Behavioral

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

eTRE

Behavioral

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

Primary outcomes

Anthropometric measurements (I)Before and after (12 weeks) of the intervention

Changes in weight (kg)

Anthropometric measurements (II)Before and after (12 weeks) of the intervention

Changes in body mass index (kg/m\^2);

Anthropometric measurements (III)Before and after (12 weeks) of the intervention

Changes waist circumference (cm)

Anthropometric measurements (IV)Before and after (12 weeks) of the intervention

Changes hip circumference (cm)

Anthropometric measurements (V)Before and after (12 weeks) of the intervention

Changes neck circumference (cm)

Body composition (I)Before and after (12 weeks) of the intervention

Changes in fat body mass (kg); assesed by bioimpedance monitoring device (Seca®)

Body composition (II)Before and after (12 weeks) of the intervention

Changes in lean body mass (kg); assesed by bioimpedance monitoring device (Seca®)

Body composition (III)Before and after (12 weeks) of the intervention

Changes visceral adipose tissue (L); assesed by bioimpedance monitoring device (Seca®)

Study locations

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Hospital Universitario de Tarragona Juan XXIII🇪🇸 Tarragona, Tarragona, Spain

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Juan Jose Vendrell Ortega, PhD, MD, ProfessorContact

Email · Call +34 977295800