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

Recruiting now · Not applicable

Conditions studied: Obesity and Obesity-related Medical Conditions

In brief

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 between18.5-24.9 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

Key facts

Study ID

NCT06858683

Run by

Hospital Universitari Vall d'Hebron Research Institute

People needed

45

Starts

2025-03-21

Expected to finish

2026-12-31

Last updated by the study team

2025-06-08

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Patients with obesity
• Women
• Age 18-64 years
• Body mass Index between 40-50 kg/m²
• Scheduled bariatric surgery 10-12 weeks after the nutritional intervention
• 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)
• Patients who have a favorable decision from the multidisciplinary team meetings after multidisciplinary nutritional follow-up of at least 6 months and history of failure with non-surgical weight loss methods
• Social security affiliation
• Written consent
• Good understanding of the Catalan or Spanish languages

You may not qualify if…

• 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.

Where it is running

• Vall Hebron Barcelona Hospital Campus — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.