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:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01590667
Eligibility Criteria:
Inclusion Criteria:
* BMI 20-30 kg/m2
* Accustomed to 3 main meals/day
* Commitment to avoid the use of other weight management products during study
* Females' agreement to use appropriate birth control methods during the active study period
* Self-reported regular bowel movement (1-2 times per day)
* Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Exclusion Criteria:
* Known sensitivity to the ingredients of the device
* Diabetes mellitus (type 1 or 2)
* History or clinical signs of endocrine disorders
* Clinically relevant excursions of safety parameter
* Current use of anti-depressants
* Presence of acute or chronic gastrointestinal disease
* Uncontrolled hypertension (more than 160/110 mm Hg)
* Stenosis in the gastrointestinal tract
* Bariatric surgery
* Abdominal surgery within the last 6 months prior to enrollment
* History of eating disorders such as bulimia, anorexia nervosa within the past 12 months
* Other serious organ or systemic diseases such as cancer
* Any medication that could influence gastrointestinal functions
* Pregnancy or nursing
* Any medication or use of products for the treatment of obesity within 6 weeks prior to enrolment
* History of abuse of drugs, alcohol or medication
* Presence of other factor(s) that, in the investigator's judgment, should preclude subject participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01590667
Study Brief:
Protocol Section:
NCT01590667