Oral Nutritional Supplement Effect on HDL Function

Study Overview
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Brief Summary
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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)

Official Title
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Evaluation of an Oral Nutritional Supplement for Effect on Total High-Density Lipoprotein (HDL) Cholesterol, HDL Functionality, Particle Size and Number

Conditions
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HDL

Intervention / Treatment
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* Dietary Supplement: CardioLux™HDL
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double-blind Placebo controlled trial. Dietary
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active HDL supplement<br>25 subjects (ages 18-85 years old) will receive an active HDL supplement (CardioLux™HDL). They will take 2 capsules twice a day with food for 12 weeks. Total daily dosing is four (4) capsules. | Dietary Supplement: CardioLux™HDL<br>* 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)<br>|
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: Placebo<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | Change from Baseline to End of Study (week 12) | 
| Dietary Intake | 24 hour recall | Change from Baseline to End of Study (week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HDL cholesterol, HDL function, HDL particle, Dietary supplement, Nutraceutical