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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT02501356
Eligibility Criteria:
Inclusion Criteria:
* BMI of 25 and over and weight not \> 350lb
* Age between 18 and 75
* Non-smokers
* Able to read and write in English
Exclusion Criteria:
* Pregnant and/or lactating women
* Evidence or history of substance or alcohol abuse (include if over 5years)
* History of major depression, bipolar disorder or schizophrenia, any type of obsessive-compulsive disorder
* Current history of migraine headaches (include if controlled with medication)
* Current use of any prescription or non-prescription weight loss products
* Tobacco use
* Active eating disorder including anorexia nervosa and bulimia
* Known sensitivity or allergy to any of the ingredients in the product
* Symptomatic coronary artery disease or congestive heart failure
* History of a stroke in the past year
* Symptomatic arrhythmia
* Uncontrolled hypertension (i.e. systolic pressure \>180 mmHg and or diastolic \> 110 mmHg)
* History of a seizure in the past 5 years
* Any cancer in the past 5 years other than non-melanoma skin cancer or in-situ cervical cancer
* Active or history of inflammatory bowel disease
* Current use of TNF-alpha inhibitor medications
* Current use of COX-2 inhibitor medications
* Current use of JAK inhibitor medications
* History of weight loss procedures including bariatric surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02501356
Study Brief:
Protocol Section:
NCT02501356