HDLNCT04097119
HDL Function Dietary Supplement Safety and QOL
A study testing Dietary supplementation in people with HDL and Health, Subjective, run by Metagenics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- HDL, Health, Subjective
- What is being tested?
- Dietary supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2019to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men: Total HDL of equal to or less than 38 mg / dL in men AND a low HDL-P of less than or equal to 7200 by Spectracell LPP Plus.
- Women: Total HDL equal to or less than 45 mg/dl in women, AND a low HDL-P of less than or equal to 7200 by Spectracell LPP Plus.
- Willingness to maintain current lifestyle (diet and exercise) practices
- Willingness to eat fish no more than twice per week and keep intake stable throughout the study
- Willingness to give written informed consent to participate in the study
- Willingness to follow lifestyle instructions for 24 hours prior to the study visit.
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- No known food allergy or intolerance to the ingredients in the study product (fish, shellfish)
- Not currently taking (washout of at least 30 days required) any other supplements that would interfere with the study results
- Not currently taking (washout of at least 30 days required) any other supplements designed to support HDL.
Who cannot join
- Use of medications classified as narcotics 30 days prior to Screening and for the duration of the study.
- Use of an investigational drug or participation in an investigational study within 30 days prior to Day 1 and for the duration of the study.
- Current use (at least 30 days wash-out required) of any lipid lowering medication which, in the view of the PI, may interfere with the results.
- Known allergy or hypersensitivity to study product.
- No initiation of a new or change of an existing exercise regimen within 15 days prior to Day 1 and for the duration of the study.
- No initiation of a new or change of an existing food plan 30 days prior to Day 1 and for the duration of the study.
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- No current involvement or within 30 days of Day 1 of a significant diet or weight loss program such as Atkin's or other Low-Carb diet programs, very low calorie liquid diet programs (such as Optifast, Medifast and/or HMR) or any diet that has led to a weight loss of 5% of body weight over a period of 10 weeks.
- No serious, unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurologic, immunologic, or hematologic disease.
- Known infection with Human Immunodeficiency Virus (HIV), Tuberculosis or Hepatitis B or C.
- Subjects with a current diagnosis or personal history of:
- Previous myocardial infarction within 5 years, Unstable angina, Previous stroke or transient ischemic attack (TIA) within 5 years, Uncompensated congestive heart failure, Previous percutaneous transluminal coronary angioplasty (PCTA) or stent within 5 years, Previous coronary artery bypass grafts (CABG) within 5 years
- Type 1 diabetes mellitus
- Any significant liver or kidney disease such as cirrhosis or non-alcoholic fatty liver disease, glomerulonephritis, and/or undergoing dialysis treatment. Cr over 2.5 mg/dL.
- Any malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for >5 years).
- Any serious mental illness including depression, manic episodes, post-traumatic disorder, obsessive-compulsive disorder, personality disorders, history of attempted suicide or violence within 12 months prior to Screening and for the duration of the study.
- Any personal history of bipolar disorders, schizophrenia or psychotic behaviors.
- Personal history of seizure disorder other than a single childhood febrile seizure that fully resolved.
- Known presence of raised intraocular pressure or history of narrow angle glaucoma.
- A major medical or surgical event requiring hospitalization within the preceding 3 months
- The presence of any disease which influences digestion and absorption of nutrients
- History of any bariatric surgery procedure
- Consumption of alcohol the evening prior to any study visit
- Use of drugs of abuse (such as marijuana, cocaine, phencyclidine [PCP] and methamphetamine) within 12 months prior to Screening and for the duration of the study.
- History of alcohol abuse or a diagnosis of alcoholism within 12 months prior to Screening and for the duration of the study.
- Inability to comply with study and/or follow-up visits.
- Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance.
- Pregnancy
- Females of child bearing age not on an accepted contraception control method
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Dietary Supplement to Support HDL Function on Safety Markers and Quality of Life
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.
Read the 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
- Being tested
- Dietary supplementation
- Keywords
- HDL function, HDL dysfunction, nutritional supplement, quality of life, dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementationDietary supplement
Subjects receive a specific dietary supplementation designed to support HDL function daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement arm | Other | Subjects to receive a specific dietary supplement Receives: Dietary Supplement: Dietary supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 - week 12
Secondary outcomes (8)
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.
Measured: 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.
Measured: 0 - week 12
Rate of HDL function
A blood test developed by Cleveland Heart Lab that reflects the function of HDL particle
Measured: 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.
Measured: 0 - week 12
Concentration of hsCRP
A blood test that measures high-sensitivity C-reactive protein (hsCRP)
Measured: 0 - week 12
Concentration of MPO
A blood test that measures myeloperoxidase (MPO)
Measured: 0 - week 12
Concentration of HDL-C
A blood test that measures high-density lipoprotein cholesterol (HDL-C) level
Measured: 0 - week 12
Number of HDL-P
A blood test that measures high-density lipoprotein cholesterol (HDL-C) particle number
Measured: 0 - week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start18 Sep 2019
- Primary completion30 Aug 2020
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HDLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metagenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hypertension Institute, Nashville
- Responsible party
- Sponsor
- Investigators
- Mark Houston, MD, Principal investigator, Hypertension Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097119
- Sponsor's protocol ID
- 2019-035-HDL
- Status last verified
- Apr 2022
- First submitted
- 18 Sep 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Dietary Supplement to Support HDL Function on Safety Markers and Quality of Life
- ClinicalTrials.gov ID
- NCT04097119
- Acronym / sponsor ID
- 2019-035-HDL
- Conditions
- HDL, Health, Subjective
- Keywords
- HDL function, HDL dysfunction, nutritional supplement, quality of life, dietary supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Metagenics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hypertension Institute, Nashville
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement arm | Other | Dietary Supplement: Dietary supplementationSubjects to receive a specific dietary supplement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men: Total HDL of equal to or less than 38 mg / dL in men AND a low HDL-P of less than or equal to 7200 by Spectracell LPP Plus.
- Women: Total HDL equal to or less than 45 mg/dl in women, AND a low HDL-P of less than or equal to 7200 by Spectracell LPP Plus.
- Willingness to maintain current lifestyle (diet and exercise) practices
- Willingness to eat fish no more than twice per week and keep intake stable throughout the study
- Willingness to give written informed consent to participate in the study
Key exclusion criteria (28 listed)
- Use of medications classified as narcotics 30 days prior to Screening and for the duration of the study.
- Use of an investigational drug or participation in an investigational study within 30 days prior to Day 1 and for the duration of the study.
- Current use (at least 30 days wash-out required) of any lipid lowering medication which, in the view of the PI, may interfere with the results.
- Known allergy or hypersensitivity to study product.
- No initiation of a new or change of an existing exercise regimen within 15 days prior to Day 1 and for the duration of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplementationSubjects receive a specific dietary supplementation designed to support HDL function daily for 12 weeks | Dietary supplement | Dietary supplement arm |
Primary outcome
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
8 secondary outcomes
Medical Outcomes Study Short Form 36 (MOS SF-36) questionnaire
Time frame: 0 - week 12
Patient-Reported Outcomes Measurement Information System (PROMIS-43) questionnaire
Time frame: 0 - week 12
Rate of HDL function
Time frame: 0 - week 12
Profile (amount) of HDL map
Time frame: 0 - week 12
Concentration of hsCRP
Time frame: 0 - week 12
Concentration of MPO
Time frame: 0 - week 12
Concentration of HDL-C
Time frame: 0 - week 12
Number of HDL-P
Time frame: 0 - week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Houston, MD principal investigator
Hypertension Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplementation in people with HDL and Health, Subjective, run by Metagenics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of participant adverse events during the supplementation period (time frame: 0 - week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.