HDL
Conditions
Keywords
HDL cholesterol, HDL function, HDL particle, Dietary supplement, Nutraceutical
Brief summary
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
Interventions
DIETARY_SUPPLEMENTCardioLux™HDL
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)
DIETARY_SUPPLEMENTPlacebo
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)
Sponsors
Metagenics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized double-blind Placebo controlled trial. Dietary
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and non-pregnant female patients or female patients of childbearing age on contraception age 18-80years. * Total HDL level 38mg/dL or lower in men and HDL 45 mg/dL or lower in women and a low HDL-P defined as less than 7000 by Spectracell LPP Plus. * CHL HDL Fx score equal to or greater than 0.9. * Patients will remain on their present diet, exercise program, medications (except for those who alter serum lipids) sleeping habits, alcohol intake, caffeine intake, smoking amount and emotional status as best as possible related to stress and anxiety and maintain body weight at baseline visit as best as possible to avoid confounding variables. * No other lipid lowering supplement can be taken during the study. * All lipid lowering supplements must have been discontinued at least 30 days prior t o study entry.
Exclusion criteria
* Pregnant females * Females of childbearing age not on an accepted contraception control method * Previous myocardial infarction within 5 years * Unstable angina * Previous stroke or TIA within 5 years * Uncompensated congestive heart failure * Previous PCTA or stent within 5 years * Previous CABG within 5 years * Patients on statins, fibrates, or other lipid lowering medications or any supplement known to affect serum lipids. * Known or previous cancer within 5 years * Type 1 diabetes mellitus * Kidney disease as defined by serum creatinine over 2.5 mg/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HDL-FX test HDL-FX test | Change from Baseline to End of Study (week 12) | Reverse Cholesterol Transport (RCT)(CEC) with Cleveland Heart Lab (CHL) |
| HDL mapping | Change from Baselineto End of study (week 12) | HDL mapping with Boston Heart Lab (BHL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myloperoxidase (MPO) | Change from Baseline to End of Study (week 12) | measured with Quest Lab test |
| LP-PLA-2 test | Change from Baseline to End of Study (week 12) | Measured with Quest Lab test |
| Dietary Intake | Change from Baseline to End of Study (week 12) | 24 hour recall |
Other
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference | Change from Baseline to End of Study (week 12) | measured in cm |
| Body Mass Index | Change from Baseline to End of Study (week 12) | measured in kg/m2 |
| Blood pressure (systolic/diastolic) | Change from Baseline to End of Study (week 12) | measured in mm Hg |
| Weight | Change from Baseline to End of Study (week 12) | measured in pounds (Lbs) |
Countries
United States
Outcome results
None listed