Oral Nutritional Supplement Effect on HDL Function (NCT04529174) | Clinical Trial Compass
CompletedNot Applicable
Oral Nutritional Supplement Effect on HDL Function
United States53 participantsStarted 2020-08-18
Plain-language summary
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HDL-FX test HDL-FX test
Timeframe: Change from Baseline to End of Study (week 12)
2
HDL mapping
Timeframe: Change from Baselineto End of study (week 12)