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Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active HDL supplement | Active Comparator | 25 subjects (ages 18-85 years old) will receive an active HDL supplement (CardioLuxâ„¢HDL). They will take 2 capsules twice a day with food for 12 weeks. Total daily dosing is four (4) capsules. |
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| Placebo | Placebo Comparator | 25 randomly selected subjects (ages 18-85 years old) will receive a matching Placebo. They will take 2 capsules twice each day with food for 12 weeks. Total daily dosing is four (4) capsules. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioLuxâ„¢HDL | Dietary Supplement | Enrollment will occur according to the inclusion/ exclusion criteria and after the review and signing of the Informed Consent form. Clinical testing will be performed at baseline and each visit (2, 3). Measurement of height, weight with body composition analysis, body mass index, waist circumference, and vital signs (blood pressure, heart rate) will be measured. Review of medical history and current medications by clinician; and collection of fasting blood for testing of the complete blood count (CBC), comprehensive metabolic profile (CMP), as well as a urine pregnancy test in females of child-bearing potential. Visits: Baseline (Visit 1), Week 6 (Visit 2) and Week 12 (Visit 3/End of Study) |
| Measure | Description | Time Frame |
|---|---|---|
| HDL-FX test HDL-FX test | Reverse Cholesterol Transport (RCT)(CEC) with Cleveland Heart Lab (CHL) | Change from Baseline to End of Study (week 12) |
| HDL mapping | HDL mapping with Boston Heart Lab (BHL) | Change from Baselineto End of study (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Myloperoxidase (MPO) | measured with Quest Lab test | Change from Baseline to End of Study (week 12) |
| LP-PLA-2 test | Measured with Quest Lab test |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | measured in pounds (Lbs) | Change from Baseline to End of Study (week 12) |
| Body Mass Index | measured in kg/m2 | Change from Baseline to End of Study (week 12) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Houston, MD | Hypertension Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hypertension Institute | Nashville | Tennessee | 37205 | United States |
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| ID | Term |
|---|---|
| C564708 | Huntington Disease-Like 2 |
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Randomized double-blind Placebo controlled trial. Dietary
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|
| Placebo | Dietary Supplement | Enrollment will occur according to inclusion /exclusion criteria and after the review and signing of the Informed Consent form. Clinical testing will be performed at baseline and each visit (2, 3). Measurement of height, weight with body composition analysis, body mass index, waist circumference, and vital signs (blood pressure, heart rate) will be measured. Review of medical history and current medications by clinician; and collection of fasting blood for testing of the complete blood count (CBC), comprehensive metabolic profile (CMP), as well as a urine pregnancy test in females of child-bearing potential. Visits: Baseline (Visit 1), Week 6 (Visit 2) and Week 12 (Visit 3/End of Study) |
|
| Change from Baseline to End of Study (week 12) |
| Dietary Intake | 24 hour recall | Change from Baseline to End of Study (week 12) |
| Waist Circumference | measured in cm | Change from Baseline to End of Study (week 12) |
| Blood pressure (systolic/diastolic) | measured in mm Hg | Change from Baseline to End of Study (week 12) |