Nutritional supplements are routinely purchased by consumers with suboptimal HDL to support their health, lifestyle and overall quality of life. Many such products receive minimal evaluation prior to marketing. This study aims to evaluate a specific nutritional supplement for its safety, tolerance and acceptability as well as the potential for positive impact on quality of life.
High density lipoprotein cholesterol (HDL), often considered the 'good cholesterol,' plays an essential role in reverse cholesterol transport (RCT), and has anti-inflammatory, anti-oxidative, and anti-thrombotic actions in the body. However, studies have shown that higher HDL cholesterol (HDL-C) levels are not always cardioprotective, and that the functionality of the HDL molecule is critical for cardioprotection. The HDL molecule is associated with many proteins (the HDL proteome) such as apolipoprotein A-one (apoA-I) and paraoxonase (PON) which are critical for its function. These proteins can be the target of oxidative damage which negatively impacts HDL functionality. Loss of HDL function leads to impaired RCT and the build of cholesterol within the vasculature with an increased risk of atherosclerotic plaque development. Gain of HDL dysfunction leads to HDL acting as a pro-inflammatory and pro-oxidant molecule, further increasing cardiovascular risk. Several dietary ingredients have been shown to support various aspects of HDL function and the HDL proteome. Examples include pomegranate juice and extract, lycopene, and quercetin. Nutritional supplements are routinely purchased by consumers with suboptimal HDL to support their health, lifestyle and overall quality of life. Many such products receive minimal evaluation prior to marketing. As part of the investigator's commitment to safe and beneficial formulating of nutritional supplements, an evaluation of both the safety, tolerance and acceptability as well as the potential for positive impact on quality of life, this study aims to collect information on relevant outcomes related to quality of life and recovery, with a view to understanding potential for benefit and areas for larger research focus.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
10
Subjects receive a specific dietary supplementation designed to support HDL function daily for 12 weeks
Hypertension Institute
Nashville, Tennessee, United States
Frequency of participant adverse events during the supplementation period
Tolerability of oral intake of the supplement will primarily be evaluated by determining the frequency of adverse events during the supplementation period
Time frame: 0 - week 12
Medical Outcomes Study Short Form 36 (MOS SF-36) questionnaire
The MOS SF-36 is an indicator of overall health status. It has an eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability.
Time frame: 0 - week 12
Patient-Reported Outcomes Measurement Information System (PROMIS-43) questionnaire
Patient-Reported Outcomes Measurement Information System (PROMIS-43) is a qualitative measure of an individual's quality of life. The questions are categorized into seven domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). A T-score in each domain will be generated based on individual's answer. A score of 50 with standard deviation of 10 reflects the general population, from which the individual's score will be compared to determine improvement or lack of.
Time frame: 0 - week 12
Rate of HDL function
A blood test developed by Cleveland Heart Lab that reflects the function of HDL particle
Time frame: 0 - week 12
Profile (amount) of HDL map
A blood test developed by Boston Heart Diagnostics that quantifies the amount of apoA-I in the five most significant HDL subpopulations, resulting in a deeper understanding of a patient's cardiovascular disease risk.
Time frame: 0 - week 12
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Concentration of hsCRP
A blood test that measures high-sensitivity C-reactive protein (hsCRP)
Time frame: 0 - week 12
Concentration of MPO
A blood test that measures myeloperoxidase (MPO)
Time frame: 0 - week 12
Concentration of HDL-C
A blood test that measures high-density lipoprotein cholesterol (HDL-C) level
Time frame: 0 - week 12
Number of HDL-P
A blood test that measures high-density lipoprotein cholesterol (HDL-C) particle number
Time frame: 0 - week 12