Status:
COMPLETED
Oral Nutritional Supplement Effect on HDL Function
Lead Sponsor:
Metagenics, Inc.
Conditions:
HDL
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04529174
Start Date
August 18 2020
End Date
December 30 2023
Last Update
March 15 2024
Active Locations (1)
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1
Hypertension Institute
Nashville, Tennessee, United States, 37205