Time-restricted eating and immune function in women with severe obesity
Exploring the Effects of Time-restricted Feeding on the Immune Function of Obese Individuals: Multi-omic Approach
This trial tests whether following an 8-hour time-restricted eating schedule improves immune function in women aged 18–64 with severe obesity compared with a longer, 14-hour eating window, using a healthy lean group for reference.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06899997 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study enrolls women aged 18–64 with severe obesity (BMI 40–50 kg/m²) and a reference group of healthy-weight women. Participants with obesity are randomized to an 8-hour time-restricted feeding window (roughly 6–8 am to 2–4 pm) or a habitual 14-hour eating window, and immune outcomes are compared between groups. The protocol uses deep immune profiling and multi-omics analyses to characterize cellular and molecular changes linked to the feeding schedules. The trial is conducted at HEGP in Paris and requires in-person visits and French social security affiliation.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–64 with BMI 40–50 kg/m² who have stable weight, a habitual eating window longer than 14 hours, a three-meal pattern, and can attend visits in Paris and read French.
Not a fit: People with diabetes, major cardiovascular disease, pregnancy, recent cancer, chronic liver or kidney disease, certain medications (anti-inflammatories, antibiotics, immunosuppressants), night-shift work, eating disorders, or chronic viral infections are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the intervention could improve immune competence and lower inflammation in women with severe obesity, potentially reducing infection risk and related complications.
How similar studies have performed: Small human and animal studies have shown that time-restricted feeding can improve metabolic markers and reduce inflammation, but robust multi-omics evidence on immune function in severe obesity is limited and this approach is relatively novel.
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 * 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) * Social security affiliation * Written consent * Good understanding of the French language Lean patients * Women * Age 18-64 years * Body mass Index between 18.5-24.9 kg/m² * Self-reported eating pattern window of more than 14h * Social security affiliation * Written consent * Good understanding of the French language 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. * Patient on AME (state medical aid)
Where this trial is running
Paris and 1 other locations
- HEGP - digestive surgery — Paris, France (Active_not_recruiting)
- HEGP - nutrition department — Paris, France (Recruiting)
Study contacts
- Study coordinator: Cléo BOURGEOIS
- Email: cleo.bourgeois@aphp.fr
- Phone: 0156095638
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.