Actively Recruiting
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
Eligibility Criteria
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
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
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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