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

Inclusion Criteria18

  • 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 Criteria15

  • 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)

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06899997


Related Trials