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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT02188251
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female 21-55 years of age
* BMI of 25.0 kg/m2 to 29.9 kg/m2 (± 1.0kg/m2)
* Must have negative urine pregnancy test at screening
* Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
* Subject agrees to maintain their normal level of physical activity throughout the study
* Weight has been stable for the last 3 months
* Subject agrees to comply with study procedures
* Healthy as determined by laboratory results, medical history and physical exam
* Subject agrees not to participate in structured activity including resistance training and aerobic exercise more than 3 times per week
* Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria:
* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
* Subject who have experienced a greater than 10% variation in body weight in the past 3 months
* History of, or current diagnosis of any major diseases of the cardiovascular, hepatic, renal, gastrointestinal, pulmonary or endocrine systems
* History of surgery for weight loss (including gastric bypass or lapband)
* History of conditions that could interfere with the test product or impede its absorption such as gastrointestinal disease (Crohn's disease) or experienced surgery (caecum or enterocele surgery)
* Subjects diagnosed with Type II Diabetes
* Subjects with active cancer (excluding basal cell carcinoma)
* Subjects with active eating disorders
* Subjects who have undergone anti-psychotic drug therapy within the past 2 months
* Use of prescription or over the counter medications known to affect weight within 3 weeks of randomization or during the study
* Use of any supplements, programs, or meal replacement products, other than those provided, intended to alter body weight within two weeks of screening or during the course of the study
* Use of illicit drugs or history of drug or alcohol abuse within the past 6 months
* Currently having more than 2 standard alcoholic drinks per day
* Participation in a clinical research trial within 30 days prior to randomization
* Allergy or sensitivity to test article ingredients
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Abnormal lab test results or any other medical or psychological condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT02188251
Study Brief:
Protocol Section:
NCT02188251