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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT03836651
Eligibility Criteria:
Inclusion Criteria: Subjects will be individuals who have a diagnosis of metabolic syndrome without overt CVD as defined by the National Cholesterol Education Program (NCEP) as evidenced by having at least 3 of the 5 following conditions:
1. Hypertension defined as SBP \>130mmHg and diastolic \>85mmHg
2. Abdominal obesity with a waist circumference greater than 88cm in women and greater than 102 cm in men
3. Triglycerides level greater than 150mg/dL
4. HDL levels less than 50mg/dL in women and less than 40mg/dL in men
5. Fasting glucose level greater than 100mg/dL Additional inclusion criteria include the ability to read and speak English, and have no cognitive impairment that precludes giving informed consent or ability to follow protocol instructions.
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Exclusion Criteria: Subjects will be excluded from the study if they: a) are less than 21 years of age; b) have a terminal illness; c) have impaired cognition; d) have a strong dislike, or have a potential food-drug interaction to V8® Low Sodium 100% vegetable juice; or e) co-existing illness documented in the medical record or self-reported associated with systemic inflammation (e.g. rheumatoid arthritis, acute systemic infection).
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT03836651
Study Brief:
Protocol Section:
NCT03836651