Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-64
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women
Age 18-64 years
Body mass Index between 40-50 kg/m²
Self-reported eating pattern window of more than 14h
Disqualifiers
Diabetes type I or II
Major cardiovascular disease
Pregnancy
Medication that could affect the study outcomes (i.e. anti-inflammatory drugs, antibiotics, immunosuppressors)
Trial design
Design model
Parallel
Treatments tested in this trial
Time-restrictred feeding
Other interventionTime-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 intervention14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Time-restricted feedingExperimental treatment 1 intervention
Group B: Non-Time restricted feedingExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
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.
Time frame
10 weeksSecondary outcomes
1
Percent of weight change from baseline
Time frame
Baseline, Week 102
Change in lean mass (expressed in kg), measured using Bioelectrical Impedance Analysis from baseline
Time frame
Baseline, Week 103
Change in fat mass (expressed in kg), measured using Bioelectrical Impedance Analysis from baseline
Time frame
Baseline, Week 104
Change in resting energy expenditure (kcal/day), measured using indirect calorimetry, from baseline
Time frame
Baseline, 10 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
National Research Agency, France
Collaborator
Source ClinicalTrials.gov