Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity
NCT ID: NCT06858683
Last Updated: 2025-06-08
Study Results
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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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-03-21
2026-12-31
Brief Summary
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The main questions it aims to answer are: i) what is the underlying cause of impaired immunocompetence in patients with obesity? ii) how nutritional interventions improve the immune function of patients with obesity? Patients with obesity following TRF (8 h eating window ranging from 6-8 am to 14-16 pm) will be compared to patients with obesity without TRF control schedule (14h eating window ranging from 6-8 am to 8-10 pm). The dietary intervention will begin 10 weeks before the scheduled date for bariatric surgery in patients with obesity. In addition to patients with obesity, the present study aims to recruit a group of a reference healthy group (BMI between18.5-24.9 kg/m²) that will not receive any nutritional intervention.
The following endpoints will be collected: Body weight and composition using Bioelectrical Impedance Analysis, resting energy expenditure (REE) using indirect calorimetry, blood glucose levels using a continuous glucose monitoring (CGM) device, metabolic parameters (fasting blood glucose levels, C-peptide, HbA1c, insulin, HOMA-IR, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, hepatic enzymes), and cytokine profile.
Blood, stool, and white adipose tissue (WAT) samples will be collected to establish metagenomic, transcriptomic, cytomic and metabolomic analyses
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Time-restricted feeding
Women with grade 3 obesity (BMI 40-50 kg/m²) who are scheduled for bariatric surgery and follow a time-restricted feeding (TRF) pattern consisting of an 8 h eating window (from 6-8 am to 14-16 pm) followed by a 16 h fasting period.
Time-restrictred feeding
Time-restricted feeding pattern consisting of an 8 h eating window (from 6-8 am to 14-16pm) followed by a 16 h fasting period.
Non-Time restricted feeding
Women with grade 3 obesity (BMI 40-50 kg/m²) who are scheduled for bariatric surgery and follow a 14h eating window (from 6-8 am to 8-10pm), followed by a 10 h fasting period.
Non-time restricted feeding
14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period.
Control
Women with a healthy body weight without any dietary intervention.
No interventions assigned to this group
Interventions
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Time-restrictred feeding
Time-restricted feeding pattern consisting of an 8 h eating window (from 6-8 am to 14-16pm) followed by a 16 h fasting period.
Non-time restricted feeding
14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period.
Eligibility Criteria
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Inclusion Criteria
* Women
* Age 18-64 years
* Body mass Index between 40-50 kg/m²
* Scheduled bariatric surgery 10-12 weeks after the nutritional intervention
* Self-reported eating pattern window of more than 14h
* Three meal eating pattern
* Stable body weight (less than 10% of current body weight during the last 3 months)
* Patients who have a favorable decision from the multidisciplinary team meetings after multidisciplinary nutritional follow-up of at least 6 months and history of failure with non-surgical weight loss methods
* Social security affiliation
* Written consent
* Good understanding of the Catalan or Spanish languages
Exclusion Criteria
* Major cardiovascular disease
* Pregnancy
* Medication that could affect the study outcomes (i.e. anti-inflammatory drugs, antibiotics, immunosuppressors)
* Use products intended for weight loss
* Night work shift
* Past record of malignant tumors
* Serious liver dysfunction or chronic kidney disease
* Eating disorders
* Chronic viral disease (Hepatitis B or C, HIV) or inflammatory systemic diseases (i.e. Crohn's disease, rheumatoid arthritis)
* Serious cardiovascular or cerebrovascular disease within 6 months before randomization
* Severe gastrointestinal diseases or gastrointestinal surgery in the 12 months before randomization
* Under guardianship, curatorship, deprived of liberty
* Unable or unwilling to sign the informed consent form.
18 Years
64 Years
FEMALE
Yes
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Locations
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Vall Hebron Barcelona Hospital Campus
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PR(AG)68/2023
Identifier Type: -
Identifier Source: org_study_id
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