Oral Nutritional Supplement Effect on HDL Function

HDL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529174
• Other study ID #: HTI-003
• Status: Completed
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: Metagenics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 30, 2023
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• HDL

Intervention

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
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)

Locations

Country	Name	City	State
United States	Hypertension Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Metagenics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	measured in pounds (Lbs)	Change from Baseline to End of Study (week 12)
Other	Body Mass Index	measured in kg/m2	Change from Baseline to End of Study (week 12)
Other	Waist Circumference	measured in cm	Change from Baseline to End of Study (week 12)
Other	Blood pressure (systolic/diastolic)	measured in mm Hg	Change from Baseline to End of Study (week 12)
Primary	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)
Primary	HDL mapping	HDL mapping with Boston Heart Lab (BHL)	Change from Baselineto End of study (week 12)
Secondary	Myloperoxidase (MPO)	measured with Quest Lab test	Change from Baseline to End of Study (week 12)
Secondary	LP-PLA-2 test	Measured with Quest Lab test	Change from Baseline to End of Study (week 12)
Secondary	Dietary Intake	24 hour recall	Change from Baseline to End of Study (week 12)