Clinical trial NCT04529174: Oral Nutritional Supplement Effect on HDL Function
Official title: Evaluation of an Oral Nutritional Supplement for Effect on Total High-Density Lipoprotein (HDL) Cholesterol, HDL Functionality, Particle Size and Number
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HDL
Keywords: HDL cholesterol
HDL function
HDL particle
Dietary supplement
Nutraceutical
Lead sponsor: Metagenics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blind Placebo controlled trial. Dietary
Primary purpose: SUPPORTIVE_CARE

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 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

Primary outcomes:
measure: HDL-FX test HDL-FX test
timeFrame: Change from Baseline to End of Study (week 12)
measure: HDL mapping
timeFrame: Change from Baselineto End of study (week 12)
Secondary outcomes:
measure: Myloperoxidase (MPO)
timeFrame: Change from Baseline to End of Study (week 12)
measure: LP-PLA-2 test
timeFrame: Change from Baseline to End of Study (week 12)
measure: Dietary Intake
timeFrame: Change from Baseline to End of Study (week 12)
Other outcomes:
measure: Weight
timeFrame: Change from Baseline to End of Study (week 12)
measure: Body Mass Index
timeFrame: Change from Baseline to End of Study (week 12)
measure: Waist Circumference
timeFrame: Change from Baseline to End of Study (week 12)
measure: Blood pressure (systolic/diastolic)
timeFrame: Change from Baseline to End of Study (week 12)
Locations:
city: Nashville
country: United States
facility: Hypertension Institute
state: Tennessee
Study officials:
affiliation: Hypertension Institute
name: Mark Houston, MD
role: PRINCIPAL_INVESTIGATOR
References: