Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
FEMALE
Healthy Volunteers
NCT06899997

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-23

24

Participants Needed

2

Research Sites

97 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

N

National Research Agency, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 64Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 64 years
  • Body mass index between 40 and 50 kg/m² for obese group
  • Body mass index between 18.5 and 24.9 kg/m² for lean group
  • Self-reported eating window longer than 14 hours daily
  • Three meals per day eating pattern (obese group)
  • Stable body weight (less than 10% change in last 3 months for obese group)
  • Social security affiliation
  • Written consent provided
  • Good understanding of French language
Not Eligible

You will not qualify if you...

  • Diabetes type I or II
  • Major cardiovascular disease
  • Pregnancy
  • Use of medications affecting study outcomes (e.g., anti-inflammatory drugs, antibiotics, immunosuppressors)
  • Use of weight loss products
  • Night shift work
  • History of malignant tumors
  • Serious liver dysfunction or chronic kidney disease
  • Eating disorders
  • Chronic viral or inflammatory systemic diseases (e.g., Hepatitis B or C, HIV, Crohn's disease, rheumatoid arthritis)
  • Serious cardiovascular or cerebrovascular disease within 6 months before randomization
  • Severe gastrointestinal diseases or surgery in past 12 months
  • Under guardianship, curatorship, or deprived of liberty
  • Unable or unwilling to sign informed consent
  • Patient on state medical aid (AME)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

HEGP - digestive surgery

Paris, France, 75015

Active, Not Recruiting

2

HEGP - nutrition department

Paris, France, 75015

Actively Recruiting

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Research Team

C

Cléo BOURGEOIS

CONTACT

S

Sébastien CZERNICHOW, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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