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

Official title

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

Overview

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.

Interventions

• Other Time-restrictred feeding
  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
• Other Non-time restricted feeding
  14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period

Primary outcome measures

• Level of inflammatory cytokine IL-1β [Time frame: 10 weeks]

Secondary outcome measures (12)

• Percent of weight change from baseline [Time frame: Baseline, Week 10]
• Change in lean mass (expressed in kg), measured using Bioelectrical Impedance Analysis from baseline [Time frame: Baseline, Week 10]
• Change in fat mass (expressed in kg), measured using Bioelectrical Impedance Analysis from baseline [Time frame: Baseline, Week 10]
• Change in resting energy expenditure (kcal/day), measured using indirect calorimetry, from baseline [Time frame: Baseline, 10 weeks]
• Change in fasting blood glucose levels from baseline [Time frame: Baseline, 10 weeks]
• Change in fasting C-peptide levels from baseline [Time frame: Baseline, 10 weeks]
• Change in HbA1c Levels from Baseline (Percentage Points) [Time frame: Baseline, 10 weeks]
• Change in fasting insulin levels from baseline [Time frame: Baseline, 10 weeks]
• Change in HOMA-IR from baseline [Time frame: Baseline, 10 weeks]
• Change in lipid profile from baseline [Time frame: Baseline, 10 weeks]
• Change in ALT and AST levels (U/L) from baseline [Time frame: Baseline, 10 weeks]
• Change in Plasma Cytokine Levels from Baseline Using Luminex Assay [Time frame: Baseline, 10 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 2 centers

• HEGP - digestive surgery — Paris
• HEGP - nutrition department — Paris

Identifiers

NCT: NCT06899997 · APHP230714 · 2023-A01185-40 · 24.04388.000237

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗