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Clinical Trials in France / NCT06899997
Recruiting Not applicable

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

NCT06899997 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2025-11-03
Last updated
2026-04-23

Condition(s) studied

Obesity and Obesity-related Medical Conditions

Investigational drug(s) / intervention(s)

Time-restrictred feedingNon-time restricted feeding

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

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

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
64 Years
Healthy volunteers
Accepted
Inclusion Criteria: Patients with obesity * Women * Age 18-64 years * Body mass Index between 40-50 kg/m² * 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) * Social security affiliation * Written consent * Good understanding of the French language Lean patients * Women * Age 18-64 years * Body mass Index between 18.5-24.9 kg/m² * Self-reported eating pattern window of more than 14h * Social security affiliation * Written consent * Good understanding of the French language Exclusion Criteria: * 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. * Patient on AME (state medical aid)

Primary outcome measure(s)

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

Trial sites (2)

FacilityCityRegionStatus
HEGP - digestive surgery Paris France Active Not Recruiting
HEGP - nutrition department Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06899997 on ClinicalTrials.gov ↗ ← All trials in France