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