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

NCT06899997 | Recruiting

• 3 other identifiers: APHP2307142023-A01185-4024.04388.000237
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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) 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

Obesity and Obesity-related Medical Conditions

Keywords

Obesity; Immune system

Outcome Measures

Primary Outcomes (1)

• Level of inflammatory cytokine IL-1β

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

  10 weeks

Secondary Outcomes (16)

• 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

Study Arms (3)

Time-restricted feeding

EXPERIMENTAL

Women with grade 3 obesity (BMI 40-50 kg/m²) follow a time-restricted feeding (TRF) pattern consisting of an 8 h eating window (from 6-8 am to 14-16 pm) followed by a 16 h fasting period.

Other: Time-restrictred feeding

Non-Time restricted feeding

EXPERIMENTAL

Women with grade 3 obesity (BMI 40-50 kg/m²) follow a 14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period.

Other: Non-time restricted feeding

Control

NO INTERVENTION

Women with a healthy body weight without any dietary intervention

Interventions

Time-restrictred feeding OTHER

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

Time-restricted feeding

Non-time restricted feeding OTHER

14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period

Non-Time restricted feeding

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• National Research Agency, France: collaborator

Study Sites (2)

HEGP - digestive surgery

Paris, 75015, France

ACTIVE NOT RECRUITING

HEGP - nutrition department

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cléo BOURGEOIS

CONTACT

0156095638; cleo.bourgeois@aphp.fr

Sébastien CZERNICHOW, MD

CONTACT

0156093067; sebastien.czernichow@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigator aim to recruit a group of patients with obesity to test the effect of TRF on immune function and a group of patients with normal weight as a reference group.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 28, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (2)