Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2025-12-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized parallel-arm design (n=40) with consecutive 1:1 allocation to either a continuous calorie restriction diet (n=20) for a healthy Mediterranean diet or an early time-restricted eating protocol + continuous caloric restriction (n=20) over 12 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

triple-blind: participants, intervention researchers - except for the nutritionist in charge of diet and lifestyle counseling - and data analysts will be blinded.

Study Groups

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Continuous caloric restriction

Continuous calorie restriction diet based on healthy Mediterranean diet recommendations

Group Type ACTIVE_COMPARATOR

Active Comparator: Continuous calorie restriction

Intervention Type 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

early (morning) time-restricted eating (eTRE) plus continuous caloric restriction diet based on healthy Mediterranean diet recommendations

Group Type EXPERIMENTAL

eTRE

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes