Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity

NCT06858683 | Recruiting

• 1 other identifier: PR(AG)68/2023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized trial is to: 1) investigate the immunological landscape of patients with obesity and conduct an in-depth functional characterization of their immune system; and 2) precisely define the effects of time-restricted feeding (TRF) on immune function in patients with obesity; 3) define the immunomodulatory properties of white adipocytes in response to TRF, and 4) uncover the underlying mechanisms by which TRF modulates the immune system patients with obesity through a multi-omics approach. 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

Conditions

Obesity and Obesity-related Medical Conditions

Outcome Measures

Primary Outcomes (1)

• Inflammatory cytokine IL-1β

  The mean difference in inflammatory cytokine IL-1β in patients with obesity after 10 weeks under TRF versus patients withobesity without TRF.

  10 weeks

Secondary Outcomes (17)

• Percent of weight change from baseline

  Baseline, 10 weeks

• Change in body composition (lean and fat mass) from baseline

  Baseline, 10 weeks

• Change in resting energy expenditure from baseline

  Baseline, 10 weeks

• Change in fasting blood glucose levels from baseline

  Baseline, 10 weeks

• Change in fasting C-peptide from baseline

  Baseline, 10 weeks

Study Arms (3)

Time-restricted feeding

EXPERIMENTAL

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.

Other: Time-restrictred feeding

Non-Time restricted feeding

EXPERIMENTAL

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.

Other: Non-time restricted feeding

Control

NO INTERVENTION

Women with a healthy body weight without any dietary intervention.

Interventions

Time-restrictred feeding OTHER

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.

Time-restricted feeding

Non-time restricted feeding OTHER

14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period.

Non-Time restricted feeding

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with obesity
• 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

You may not qualify if:

• Diabetes type I or II
• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall Hebron Barcelona Hospital Campus

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Josep A. Villena Delgado

CONTACT

+ 34 937372429; josep.villena@vhir.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigator aim to recruit a group of patients with obesity to test the effect of TRF on immune function and a group of patients with normal weight as a reference group.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication.
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with EuropeanGeneral Data Protection Regulation (GDPR).

Locations

ES (1)