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NCT06899997: OBESIMM

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

Not yet recruiting NA Last updated 28 March 2025
What this trial tests

NA trial testing Time-restrictred feeding in Obesity and Obesity-related Medical Conditions in 24 participants. Not yet recruiting.

Timeline
1 April 2025
Primary endpoint
1 March 2027
1 March 2027

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment24
Start date1 April 2025
Primary completion1 March 2027
Estimated completion1 March 2027
Sites2 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 64, female only, with Obesity and Obesity-related Medical Conditions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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) define the immunomodulatory properties of white adipocytes in response to TRF, and 4) 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). The dietary intervention will begin 10 weeks before the scheduled date for bariatric surgery in patients with obesity. 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, stool, and white adipose tissue (WAT) samples will be collected to establish metagenomic, transcriptomic, cytomic and metabolomic analyses.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Time-restrictred feeding

Trials testing the same drug.

Other recruiting trials for Obesity and Obesity-related Medical Conditions

Currently open trials in the same condition.

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06899997.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing