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NCT Number: NCT06899997

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

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.

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Key information

Conditions

Obesity and Obesity-related Medical Conditions Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HEGP - digestive surgery, Paris, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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)

Treatment and study plan

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

Non-time restricted feeding

Other

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

Primary outcomes

  1. Level of inflammatory cytokine IL-1β

    Time frame: 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 outcomes

  1. Percent of weight change from baseline

    Time frame: Baseline, Week 10

  2. Change in lean mass (expressed in kg), measured using Bioelectrical Impedance Analysis from baseline

    Time frame: Baseline, Week 10

  3. Change in fat mass (expressed in kg), measured using Bioelectrical Impedance Analysis from baseline

    Time frame: Baseline, Week 10

  4. Change in resting energy expenditure (kcal/day), measured using indirect calorimetry, from baseline

    Time frame: Baseline, 10 weeks

  5. Change in fasting blood glucose levels from baseline

    Time frame: Baseline, 10 weeks

  6. Change in fasting C-peptide levels from baseline

    Time frame: Baseline, 10 weeks

  7. Change in HbA1c Levels from Baseline (Percentage Points)

    Time frame: Baseline, 10 weeks

  8. Change in fasting insulin levels from baseline

    Time frame: Baseline, 10 weeks

  9. Change in HOMA-IR from baseline

    Time frame: Baseline, 10 weeks

  10. Change in lipid profile from baseline

    Time frame: Baseline, 10 weeks

  11. Change in ALT and AST levels (U/L) from baseline

    Time frame: Baseline, 10 weeks

  12. Change in Plasma Cytokine Levels from Baseline Using Luminex Assay

    Time frame: Baseline, 10 weeks

  13. Changes in blood metabolome evaluated by gas chromatography and liquid chromatography coupled with high-resolution mass spectrometry

    Time frame: Baseline, 10 weeks

  14. Changes in gut microbiome diversity using shotgun metagenomics

    Time frame: Baseline, 10 weeks

  15. Changes in gene expression profile assessed by RNA sequencing

    Time frame: Baseline, 10 weeks

  16. Changes in blood immune cell populations measured using spectral flow cytometry

    Time frame: Baseline, 10 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Cléo BOURGEOIS

CONTACT

[email protected]

0156095638 ext. +33

Sébastien CZERNICHOW, MD

CONTACT

[email protected]

0156093067 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • National Research Agency, France

Registry information

Official study title

Exploring the Effects of Time-restricted Feeding on the Immune Function of Obese Individuals: Multi-omic Approach

Acronym: OBESIMM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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