NCT04529174Completed
Oral Nutritional Supplement Effect on HDL Function
Evaluation of an Oral Nutritional Supplement for Effect on Total High-Density Lipoprotein (HDL) Cholesterol, HDL Functionality, Particle Size and Number
Source: ClinicalTrials.gov · Last updated 15 Mar 2024
Brief summary (registry, in English)
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 21 Aug 2020
- Start date
- 18 Aug 2020
- Primary completion date
- 30 Apr 2021
- Lead sponsor
- Metagenics, Inc.
- NCT number
- NCT04529174
What you commit to
- Study type: Interventional
- Participants enrolled: 53
- From 18 Aug 2020 to the primary completion date, 30 Apr 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous myocardial infarction within 5 years
- Previous stroke or TIA within 5 years
- Previous PCTA or stent within 5 years
- Previous CABG within 5 years
Other illness
- Unstable angina
- Uncompensated congestive heart failure
- Known or previous cancer within 5 years
- Type 1 diabetes mellitus
Lab values
- Patients on statins, fibrates, or other lipid lowering medications or any supplement known to affect serum lipids.
- Kidney disease as defined by serum creatinine over 2.5 mg/dL
Age
- Females of childbearing age not on an accepted contraception control method
Other
- Pregnant females
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hypertension Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.