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CompletedNCT04529174Updated Mar 15, 2024

Oral Nutritional Supplement Effect on HDL Function

An interventional study of CardioLux™HDL and Placebo in HDL, sponsored by Metagenics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Metagenics, Inc. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • HDL

Keywords

  • HDL cholesterol
  • HDL function
  • HDL particle
  • Dietary supplement
  • Nutraceutical
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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 0.9.
  • 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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
53 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementCardioLux™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)

  • Dietary supplementPlacebo

    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)

05

What researchers measure

Primary outcomes

  1. HDL-FX test HDL-FX test

    Reverse Cholesterol Transport (RCT)(CEC) with Cleveland Heart Lab (CHL)

    Time frame: Change from Baseline to End of Study (week 12)

  2. HDL mapping

    HDL mapping with Boston Heart Lab (BHL)

    Time frame: Change from Baselineto End of study (week 12)

Secondary outcomes

  1. Myloperoxidase (MPO)

    measured with Quest Lab test

    Time frame: Change from Baseline to End of Study (week 12)

  2. LP-PLA-2 test

    Measured with Quest Lab test

    Time frame: Change from Baseline to End of Study (week 12)

  3. Dietary Intake

    24 hour recall

    Time frame: Change from Baseline to End of Study (week 12)

Other outcomes

  1. Weight

    measured in pounds (Lbs)

    Time frame: Change from Baseline to End of Study (week 12)

  2. Body Mass Index

    measured in kg/m2

    Time frame: Change from Baseline to End of Study (week 12)

  3. Waist Circumference

    measured in cm

    Time frame: Change from Baseline to End of Study (week 12)

  4. Blood pressure (systolic/diastolic)

    measured in mm Hg

    Time frame: Change from Baseline to End of Study (week 12)

06

Study locations

1 site
  • Hypertension Institute
    Nashville, Tennessee 37205, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04529174
Lead sponsor
Metagenics, Inc.
Responsible party
Sponsor
First posted
Aug 27, 2020
Start date
Aug 18, 2020
Primary completion
Apr 30, 2021
Completion
Dec 30, 2023
Last update
Mar 15, 2024

Study contacts

Mark Houston, MD
principal investigator · Hypertension Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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