Status:
NOT_YET_RECRUITING
Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
National Research Agency, France
Conditions:
Obesity and Obesity-related Medical Conditions
Eligibility:
FEMALE
18-64 years
Phase:
NA
Brief Summary
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) precisel...
Eligibility Criteria
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 favourable 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 French language
- Lean patients
- Women
- Age 18-64 years
- Body mass Index between 18.5-24.9 kg/m²
- Scheduled banal surgery in the opinion of the investigator
- Self-reported eating pattern window of more than 14h
- Social security affiliation
- Written consent
- Good understanding of the French language
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06899997
Start Date
April 1 2025
End Date
March 1 2027
Last Update
March 28 2025
Active Locations (2)
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1
HEGP - digestive surgery
Paris, France, 75015
2
HEGP - nutrition department
Paris, France, 75015