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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT02353104
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥ 25 and ≤ 35 kg/m2
* Blood pressure:
* SBP: 140-160 mmHg
* DBP: 80-90 mmHg
* Judged by the Investigator to be in general good health on the basis of medical history
* Females of child bearing potential must agree to use appropriate birth control methods during the entire study period.
* Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
Exclusion Criteria:
* Subjects currently taking any antihypertensive medications
* Subjects taking prescription blood pressure, cholesterol and/or diabetes medication.
* Subjects currently taking dietary supplements or over the counter medication. (2 week washout allowed)
* History or presence of cancer in the prior two years.
* Recent history of (within 12 months) or strong potential for alcohol or substance abuse.
* Current tobacco smokers
* Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.
* Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
* Including subjects who are Bed or wheelchair-bound
* Clinically significant abnormal Physical Examination.
* Central Neurological disorders including but not limited to Spinal cord injuries, multiple sclerosis, and Parkinson disease.
* Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study.
* Any other condition that, in the opinion of the investigator, would adversely affect the subject's ability to complete the study or its measures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02353104
Study Brief:
Protocol Section:
NCT02353104