Oral Nutritional Supplement Effect on HDL Function

NCT04529174 | Completed

• 1 other identifier: HTI-003
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HDL

Keywords

HDL cholesterol; HDL function; HDL particle; Dietary supplement; Nutraceutical

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Myloperoxidase (MPO)

  Change from Baseline to End of Study (week 12)

• LP-PLA-2 test

  Change from Baseline to End of Study (week 12)

• Dietary Intake

  Change from Baseline to End of Study (week 12)

Other Outcomes (4)

• Weight

  Change from Baseline to End of Study (week 12)

• Body Mass Index

  Change from Baseline to End of Study (week 12)

• Waist Circumference

  Change from Baseline to End of Study (week 12)

Study Arms (2)

Active HDL supplement

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

CardioLux™HDL DIETARY_SUPPLEMENT

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)

Active HDL supplement

Placebo DIETARY_SUPPLEMENT

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)

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Metagenics, Inc.: lead

Study Sites (1)

Hypertension Institute

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Huntington Disease-Like 2

Study Officials

• Mark Houston, MD

  Hypertension Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized double-blind Placebo controlled trial. Dietary

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 27, 2020
• Study Start: August 18, 2020
• Primary Completion: April 30, 2021
• Study Completion: December 30, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)