Active Comparator: Continuous calorie restrictioneTRE
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
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
Study 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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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®)
Brown fat — Before and after (12 weeks) of the intervention Changes in brown fat volume (cm3); assessed by magnetic resonance image (MRI)
Trial sites (1)
Facility
City
Region
Status
Hospital Universitario de Tarragona Juan XXIII
Tarragona
Tarragona
Recruiting
More Institut Investigacio Sanitaria Pere Virgili trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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