Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity
Recruiting · NCT06858683 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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
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.
Where it is running
1 location listed.
- Vall Hebron Barcelona Hospital Campus - Barcelona, Spain