RecruitingNot ApplicableNCT06899997

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

Exploring the Effects of Time-restricted Feeding on the Immune Function of Obese Individuals: Multi-omic Approach


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

24 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Non-time restricted feeding and Time-restrictred feeding for people with obesity and obesity-related medical conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTime-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

OTHERNon-time restricted feeding

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


Locations(2)

HEGP - digestive surgery

Paris, France

HEGP - nutrition department

Paris, France

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NCT06899997


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