NCT06858683Recruiting
Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity
Exploring the Effects of Time-Restricted Feeding on the Immune Function of Obese Individuals: A Multi-Omic Approach
Source: ClinicalTrials.gov · Last updated 8 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 27 Feb 2025
- Start date
- 21 Mar 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Diseases
- Obesity
- NCT number
- NCT06858683
What you commit to
- Study type: Interventional
- Planned participants: 45
- From 21 Mar 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medication that could affect the study outcomes (i.e. anti-inflammatory drugs, antibiotics, immunosuppressors)
- Serious cardiovascular or cerebrovascular disease within 6 months before randomization
- Severe gastrointestinal diseases or gastrointestinal surgery in the 12 months before randomization
Other illness
- Diabetes type I or II
- Major cardiovascular disease
- 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)
Other
- Pregnancy
- Use products intended for weight loss
- Night work shift
- Under guardianship, curatorship, deprived of liberty
- Unable or unwilling to sign the informed consent form.
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vall Hebron Barcelona Hospital Campus Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.