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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
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
14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period
HEGP - digestive surgery
Paris, France
ACTIVE_NOT_RECRUITINGHEGP - nutrition department
Paris, France
RECRUITINGLevel 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.
Time frame: 10 weeks
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
Changes in blood metabolome evaluated by gas chromatography and liquid chromatography coupled with high-resolution mass spectrometry
Time frame: Baseline, 10 weeks
Changes in gut microbiome diversity using shotgun metagenomics
Time frame: Baseline, 10 weeks
Changes in gene expression profile assessed by RNA sequencing
Time frame: Baseline, 10 weeks
Changes in blood immune cell populations measured using spectral flow cytometry
Time frame: Baseline, 10 weeks
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