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

Not Applicable

Not yet recruiting

• Conditions: Obesity and Obesity-related Medical Conditions

• Registration Number: NCT06899997
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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) define the immunomodulatory properties of white adipocytes in response to TRF, and 4) 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). The dietary intervention will begin 10 weeks before the scheduled date for bariatric surgery in patients with obesity. 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, stool, and white adipose tissue (WAT) samples will be collected to establish metagenomic, transcriptomic, cytomic and metabolomic analyses.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Start: 2025-04-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Patients with obesity

• Women
• Age 18-64 years
• Body mass Index between 40-50 kg/m²
• Scheduled bariatric surgery 10-12 weeks after the nutritional intervention
• 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)
• Patients who have a favourable decision from the multidisciplinary team meetings after multidisciplinary nutritional follow-up of at least 6 months and history of failure with non-surgical weight loss methods
• 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
• Scheduled banal surgery in the opinion of the investigator
• Self-reported eating pattern window of more than 14h
• Social security affiliation
• Written consent
• Good understanding of the French language

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Level of inflammatory cytokine IL-1β	10 weeks	The mean difference in inflammatory cytokine IL-1β in patients with obesity after 10 weeks under TRF versus patients with obesity without TRF.

Secondary Outcome Measures

Name	Time	Method
Percent of weight change from baseline	Baseline, Week 10
Change in lean mass (expressed in kg), measured using Bioelectrical Impedance Analysis from baseline	Baseline, Week 10
Change in fat mass (expressed in kg), measured using Bioelectrical Impedance Analysis from baseline	Baseline, Week 10
Change in resting energy expenditure (kcal/day), measured using indirect calorimetry, from baseline	Baseline, 10 weeks
Change in fasting blood glucose levels from baseline	Baseline, 10 weeks
Change in fasting C-peptide levels from baseline	Baseline, 10 weeks
Change in HbA1c Levels from Baseline (Percentage Points)	Baseline, 10 weeks
Change in fasting insulin levels from baseline	Baseline, 10 weeks
Change in HOMA-IR from baseline	Baseline, 10 weeks
Change in lipid profile from baseline	Baseline, 10 weeks
Change in ALT and AST levels (U/L) from baseline	Baseline, 10 weeks
Change in Plasma Cytokine Levels from Baseline Using Luminex Assay	Baseline, 10 weeks
Changes in blood metabolome evaluated by gas chromatography and liquid chromatography coupled with high-resolution mass spectrometry	Baseline, 10 weeks
Changes in gut microbiome diversity using shotgun metagenomics	Baseline, 10 weeks
Changes in adipose tissue metabolome	Baseline, 10 weeks
Changes in gene expression profile assessed by RNA sequencing	Baseline, 10 weeks
Changes in blood immune cell populations measured using spectral flow cytometry	Baseline, 10 weeks
Changes in adipose tissue immune cell populations	Baseline, 10 weeks

Trial Locations

Locations (2)

HEGP - digestive surgery; 🇫🇷 Paris, France

HEGP - nutrition department; 🇫🇷 Paris, France