Oral Nutritional Supplement Effect on HDL Function

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

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

Study Overview

• Status: Completed
• Conditions: HDL
• Intervention / Treatment: Dietary supplement: CardioLux™HDL; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Hypertension Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: CardioLux™HDL; 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)
Placebo Comparator: 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.	Dietary supplement: Placebo; 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)

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	measured in pounds (Lbs)	Change from Baseline to End of Study (week 12)
Body Mass Index	measured in kg/m2	Change from Baseline to End of Study (week 12)
Waist Circumference	measured in cm	Change from Baseline to End of Study (week 12)
Blood pressure (systolic/diastolic)	measured in mm Hg	Change from Baseline to End of Study (week 12)

Collaborators and Investigators

• Sponsor: Metagenics, Inc.
• Investigators: Principal Investigator: Mark Houston, MD, Hypertension Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Dietary supplement; Nutraceutical; HDL cholesterol; HDL function; HDL particle
• Other Study ID Numbers: HTI-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No