Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity
Recruiting now · Not applicable
Conditions studied: Obesity and Obesity-related Medical Conditions
In brief
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.
Key facts
- Study ID
- NCT06899997
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 24
- Starts
- 2025-11-03
- Expected to finish
- 2027-09-15
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older, up to 64. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- HEGP - nutrition department — Paris, France (enrolling)
- HEGP - digestive surgery — Paris, France
Full record on ClinicalTrials.gov
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