Time-restricted feeding for immune health in people with severe obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with obesity (BMI 40–50 kg/m²) scheduled for bariatric surgery will be randomized to follow time-restricted feeding (8-hour eating window) or a standard longer eating window for about 10–12 weeks before surgery. Researchers will collect blood and tissue samples and use multi-omics techniques to profile immune cells and how white fat cells respond to the diet change. The trial compares immune function and molecular signatures between the two groups to identify mechanisms linking feeding time to immune competence. Outcomes aim to define whether TRF can restore immune responses impaired in severe obesity and how adipocytes contribute to those changes.

Why it matters

Who can join: the full rules

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's running

• Vall Hebron Barcelona Hospital Campus
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Josep A. Villena Delgado
• Email: josep.villena@vhir.org
• Phone: + 34 937372429

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.