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

NCT06899997 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-23

No results posted yet for this study

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) 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). In addition to patients with obesity, the present study aims to recruit a group of a reference healthy group (BMI between 18.5-24.9 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 and stool, samples will be collected to establish metagenomic, transcriptomic, cytomic and metabolomic analyses.

Conditions

  • Obesity and Obesity-related Medical Conditions

Interventions

OTHER

Time-restrictred feeding

Time-restricted feeding pattern consisting of an 8 h eating window (from 6-8 am to 14-16 pm) followed by a 16 h fasting period

OTHER

Non-time restricted feeding

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

Sponsors & Collaborators

  • National Research Agency, France

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2027-09-15
Completion
2027-09-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06899997 on ClinicalTrials.gov