Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

Last updated: October 3, 2024
Sponsor: Institut Investigacio Sanitaria Pere Virgili
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Obesity

Treatment

Active Comparator: Continuous calorie restriction

eTRE

Clinical Study ID

NCT06395246
PI23/01133
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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 forthose related to excess weight.

  4. Signature of the informed consent for participation in the study.

Exclusion

Exclusion Criteria:

  1. Serious systemic disease not related to obesity, such as cancer, kidney or severeliver disease.

  2. Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such asrheumatoid 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 nonsteroidalanti-inflammatory drugs.

  8. Recent antibiotic treatment.

  9. Uncontrolled alcoholism or drug abuse.

  10. Rotating or nocturnal shift workers.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Active Comparator: Continuous calorie restriction
Phase:
Study Start date:
May 20, 2024
Estimated Completion Date:
December 20, 2025

Study Description

The specific objectives are:

  1. To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects.

  2. Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones.

  3. Define the "digital footprint" of EVs as inter-organ communication elements influencing metabolic status in obese subjects.

The study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction (DCR) (n=20) or an eTRE protocol (n=20) for 12 weeks. Clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. Derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. Glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) dynamics after a standard meal test. Metagenomics. Bioenergetic analysis of PBMC by SeaHorse. Total EV miRNA profile. Isolation of host and bacterial EVs. Characterization of the protein cargo of host and bacterial EVs.

Connect with a study center

  • Hospital Universitario de Tarragona Juan XXIII

    Tarragona, 43005
    Spain

    Active - Recruiting

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