NCT04097119

HDL Function Dietary Supplement Safety and QOL

Impact of a Dietary Supplement to Support HDL Function on Safety Markers and Quality of Life

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Metagenics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• HDL
• Health, Subjective

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary supplementation	Subjects receive a specific dietary supplementation designed to support HDL function daily for 12 weeks

Timeline

• Start date: 2019-09-18
• Primary completion: 2020-08-30
• Completion: 2022-12-30
• First posted: 2019-09-20
• Last updated: 2022-04-06

Locations

1 site across 1 country: United States