Oral Nutritional Supplement Effect on HDL Function

Metagenics

Status: Completed

Conditions: HDL

Treatments: Dietary Supplement: CardioLux™HDL; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04529174

HTI-003

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups, including a placebo group

Active HDL supplement

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: CardioLux™HDL

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo