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 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 12:15 AM
NCT ID:
NCT01725958
Eligibility Criteria:
Inclusion Criteria:
1. Females and Males aged 25-65 years
2. Signed informed consent
3. BMI between 25 and 40 kg/m2
4. A resting normotensive blood pressure is defined as a systolic blood pressure between 90-145 mmHg and a diastolic blood pressure of 50 90 mmHg
5. Use of effective method of contraception by females of childbearing \[potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study\]. Acceptable methods of contraception include oral, injectable, or implantable contraceptives; intrauterine devices, diaphragm plus spermicide; abstinence (must agree to use double-barrier method if they become sexually active), transdermal patch, or any double barrier method including a vasectomized sexual partner. Women who have had a hysterectomy or tubal ligation at least 6 months prior to Visit 1 or who have been post-menopausal
6. Ability to speak and understand English
7. Willing to fast the morning of visit where blood samples are taken
Exclusion Criteria:
1. Self-reported chronic condition that may affect subject safety (e.g., diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g., chronic fatigue)
2. Pregnancy/suspected pregnancy, breastfeeding or planning to become pregnant during the course of the study.
3. Use of Antihypertensive medication for less than 4 months or unregulated clinically blood pressure.
4. Having undergone gastroplasty or bariatric surgery in the past 10 years.
5. Taking medication (e.g., thyroid medication), must be stable for at least four months.
6. Allergies to any ingredients contained in the Nutritional Supplement.
7. Medical treatment for insomnia or depression within 30-days prior to the screening visit.
8. Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine patches) use within 30-days prior to the screening visit.
9. Planned surgical procedure during the course of the study.
10. Currently participating in another study or have done so within 30 days prior to the screening visit or is likely to enroll in another clinical or nutritional study.
11. Currently taking any medication or supplement for the use of weight loss must be discontinued prior to Visit 1 Baseline Day 0.
12. Currently participating in a weight loss program or participated in a weight loss program in the past 6 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT01725958
Study Brief:
Protocol Section:
NCT01725958