Time-restricted eating and immune function in women 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

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.

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
* 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 it's running

• HEGP - nutrition department
  Paris, France Recruiting
• HEGP - digestive surgery
  Paris, France Active not recruiting

Study contacts

• Study coordinator: Cléo BOURGEOIS
• Email: cleo.bourgeois@aphp.fr
• Phone: 0156095638

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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.