Oral Nutritional Supplement Effect on HDL Function

Not Applicable

Completed

• Conditions: HDL
• Interventions: Dietary Supplement: CardioLux™HDL; Dietary Supplement: Placebo

• Registration Number: NCT04529174
• Lead Sponsor: Metagenics, Inc.

Brief Summary

Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-18
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-27
• Primary Completion: 2021-04-30
• Study Completion: 2023-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active HDL supplement	CardioLux™HDL	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Myloperoxidase (MPO)	Change from Baseline to End of Study (week 12)	measured with Quest Lab test

Trial Locations

Locations (1)

Hypertension Institute; 🇺🇸 Nashville, Tennessee, United States