Time-restricted feeding for immune health in people with severe obesity
Exploring the Effects of Time-Restricted Feeding on the Immune Function of Obese Individuals: A Multi-Omic Approach
This trial will test whether eating only during an 8-hour window improves immune function in adults with severe obesity who are preparing for bariatric surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | Female |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06858683 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–64 with BMI 40–50 kg/m² who are scheduled for bariatric surgery in about 10–12 weeks, have had stable weight and a three-meal pattern, and can speak Catalan or Spanish and attend Vall d'Hebron in Barcelona.
Not a fit: People with type 1 or type 2 diabetes, major cardiovascular disease, current pregnancy, recent cancer, use of immunosuppressive or interfering medications, night-shift workers, or those who cannot follow the language or location requirements are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, the intervention could improve immune function and reduce immune-related complications around bariatric surgery for people with severe obesity.
How similar studies have performed: Previous time-restricted feeding studies have shown metabolic benefits, but using TRF specifically to modify immune function and adipocyte immunomodulation is relatively novel and less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Barcelona
- Vall Hebron Barcelona Hospital Campus — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Josep A. Villena Delgado
- Email: josep.villena@vhir.org
- Phone: + 34 937372429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.