HDL Function Dietary Supplement Safety and QOL
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|ClinicalTrials.gov Identifier: NCT04097119|
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|HDL Health, Subjective||Dietary Supplement: Dietary supplementation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of a Dietary Supplement to Support HDL Function on Safety Markers and Quality of Life|
|Actual Study Start Date :||September 18, 2019|
|Estimated Primary Completion Date :||January 30, 2020|
|Estimated Study Completion Date :||March 30, 2020|
Dietary supplement arm
Subjects to receive a specific dietary supplement
Dietary Supplement: Dietary supplementation
Subjects receive a specific dietary supplementation designed to support HDL function daily for 12 weeks
- Frequency of participant adverse events during the supplementation period [ Time Frame: 0 - week 12 ]Tolerability of oral intake of the supplement will primarily be evaluated by determining the frequency of adverse events during the supplementation period
- Medical Outcomes Study Short Form 36 (MOS SF-36) questionnaire [ Time Frame: 0 - week 12 ]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.
- Patient-Reported Outcomes Measurement Information System (PROMIS-43) questionnaire [ Time Frame: 0 - week 12 ]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.
- Rate of HDL function [ Time Frame: 0 - week 12 ]A blood test developed by Cleveland Heart Lab that reflects the function of HDL particle
- Profile (amount) of HDL map [ Time Frame: 0 - week 12 ]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.
- Concentration of hsCRP [ Time Frame: 0 - week 12 ]A blood test that measures high-sensitivity C-reactive protein (hsCRP)
- Concentration of MPO [ Time Frame: 0 - week 12 ]A blood test that measures myeloperoxidase (MPO)
- Concentration of HDL-C [ Time Frame: 0 - week 12 ]A blood test that measures high-density lipoprotein cholesterol (HDL-C) level
- Number of HDL-P [ Time Frame: 0 - week 12 ]A blood test that measures high-density lipoprotein cholesterol (HDL-C) particle number
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097119
|Contact: Annalouise O'Connor, PhDfirstname.lastname@example.org|
|Contact: Ilona Larson, PhDemail@example.com|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37205|
|Contact: Mark Houston, MD 615-297-5551|
|Principal Investigator:||Mark Houston, MD||Hypertension Institute|