Evaluation of an Oral Nutritional Supplement for Effect on Total High-Density Lipoprotein (HDL) Cholesterol, HDL Functionality, Particle Size and Number
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Metagenics, Inc.
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- HDL-FX test HDL-FX test
Study Overview
Brief Summary
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
- •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
Arms & Interventions
Active HDL supplement
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.
Intervention: CardioLux™HDL (Dietary Supplement)
Placebo
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.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
HDL-FX test HDL-FX test
Time Frame: Change from Baseline to End of Study (week 12)
Reverse Cholesterol Transport (RCT)(CEC) with Cleveland Heart Lab (CHL)
HDL mapping
Time Frame: Change from Baselineto End of study (week 12)
HDL mapping with Boston Heart Lab (BHL)
Secondary Outcomes
- LP-PLA-2 test(Change from Baseline to End of Study (week 12))
- Dietary Intake(Change from Baseline to End of Study (week 12))
- Myloperoxidase (MPO)(Change from Baseline to End of Study (week 12))