Tests time-restricted eating and immune function in adults with obesity
Compares an 8-hour daily eating window with usual eating in adults with obesity.
Plain-language title generated from the registry record
Registry title: Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity
Key facts
- Where
- Barcelona, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT06858683, who can take part
Where in Spain
- Vall Hebron Barcelona Hospital CampusBarcelona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitari Vall d'Hebron Research Institute
- Trial code
- NCT06858683
- Record updated
- 8 June 2025
- Original 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.Read full original descriptionShow less
Exploring the Effects of Time-Restricted Feeding on the Immune Function of Obese Individuals: A Multi-Omic Approach
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
Inclusion: 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: 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; 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); 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.