Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01797757
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65
* Sex female
* Body Mass Index (BMI) ≥ 30kg/m2 and \< 40kg/m2
* Subjects willing to undergo treatment with Orlistat® (Xenical).
* Having obtained her written informed consent before any study related procedure including the pre-inclusion period.
Subject exclusion criteria:
* Binge eating disorder
* Any other weight loss treatment(s) within the last 3 months
* Vegetarians
* History of metabolic, cardiovascular, hepatic or renal diseases
* Obstructed bile duct
* Diseases that could interfere with intestinal absorption History of abdominal / gastric surgery (except appendicectomy)
* Use of drugs or illicit substances
* Consumption of alcohol \> 50 gr/week
* Any other clinically significant abnormalities on screening laboratory evaluation (creatinine, Na, K, urique acide, ASAT, ALAT, Ph. Alc., yGT, Glycemia, total cholesterol, HDL, LDL, triglycerides) concentrations \> 2.5 fold normal range
* Pregnant or lactating mothers
* Allergy to fish oil or other components (for e.g., gelatin or excepients of the capsule)
* Use of any other supplements containing fish oil for the duration of the trial or 3 month before inclusion in trial.
* Smokers
* Having donated blood or had a transfusion of blood/blood products during the trial and 3 months prior to screening or expected to do so during the study
* Bleeding disorders
* Subject who cannot be expected to comply with the study procedures.
* Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01797757
Study Brief:
Protocol Section:
NCT01797757