HDLNCT04529174
Oral Nutritional Supplement Effect on HDL Function
A study testing CardioLux™HDL in people with HDL, run by Metagenics, Inc. at 1 site in United States.
Trial summary
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P) Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- HDL
- What is being tested?
- CardioLux™HDL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2020to 30 Dec 2023
- 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
- 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.
Who cannot join
- Pregnant females
- Females of childbearing age not on an accepted contraception control method
- Previous myocardial infarction within 5 years
- Unstable angina
- Previous stroke or TIA within 5 years
- Uncompensated congestive heart failure
Show all 12Show fewer
- Previous PCTA or stent within 5 years
- Previous CABG within 5 years
- Patients on statins, fibrates, or other lipid lowering medications or any supplement known to affect serum lipids.
- Known or previous cancer within 5 years
- Type 1 diabetes mellitus
- Kidney disease as defined by serum creatinine over 2.5 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Oral Nutritional Supplement for Effect on Total High-Density Lipoprotein (HDL) Cholesterol, HDL Functionality, Particle Size and Number
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
- Conditions
- HDL
- Being tested
- CardioLux™HDL, Placebo
- Keywords
- HDL cholesterol, HDL function, HDL particle, Dietary supplement, Nutraceutical
- Medical subject headings
- Huntington Disease-Like 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioLux™HDLDietary supplement
Enrollment will occur according to the inclusion/ exclusion criteria and after the review and signing of the Informed Consent form. Clinical testing will be performed at baseline and each visit (2, 3).
Measurement of height, weight with body composition analysis, body mass index, waist circumference, and vital signs (blood pressure, heart rate) will be measured.
Review of medical history and current medications by clinician; and collection of fasting blood for testing of the complete blood count (CBC), comprehensive metabolic profile (CMP), as well as a urine pregnancy test in females of child-bearing potential.
Visits: Baseline (Visit 1), Week 6 (Visit 2) and Week 12 (Visit 3/End of Study)
PlaceboDietary supplement
Enrollment will occur according to inclusion /exclusion criteria and after the review and signing of the Informed Consent form. Clinical testing will be performed at baseline and each visit (2, 3).
Measurement of height, weight with body composition analysis, body mass index, waist circumference, and vital signs (blood pressure, heart rate) will be measured.
Review of medical history and current medications by clinician; and collection of fasting blood for testing of the complete blood count (CBC), comprehensive metabolic profile (CMP), as well as a urine pregnancy test in females of child-bearing potential.
Visits: Baseline (Visit 1), Week 6 (Visit 2) and Week 12 (Visit 3/End of Study)
| Study group | Role | What they receive |
|---|---|---|
| Active HDL supplement | Active comparator | 25 subjects (ages 18-85 years old) will receive an active HDL supplement (CardioLux™HDL). They will take 2 capsules twice a day with food for 12 weeks. Total daily dosing is four (4) capsules. Receives: Dietary Supplement: CardioLux™HDL |
| Placebo | Placebo comparator | 25 randomly selected subjects (ages 18-85 years old) will receive a matching Placebo. They will take 2 capsules twice each day with food for 12 weeks. Total daily dosing is four (4) capsules. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL-FX test HDL-FX test
Reverse Cholesterol Transport (RCT)(CEC) with Cleveland Heart Lab (CHL)
Measured: Change from Baseline to End of Study (week 12)
HDL mapping
HDL mapping with Boston Heart Lab (BHL)
Measured: Change from Baselineto End of study (week 12)
Secondary outcomes (3)
Myloperoxidase (MPO)
measured with Quest Lab test
Measured: Change from Baseline to End of Study (week 12)
LP-PLA-2 test
Measured with Quest Lab test
Measured: Change from Baseline to End of Study (week 12)
Dietary Intake
24 hour recall
Measured: Change from Baseline to End of Study (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start18 Aug 2020
- Primary completion30 Apr 2021
- Study completion30 Dec 2023
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind Placebo controlled trial. Dietary
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metagenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Houston, MD, Principal investigator, Hypertension Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529174
- Sponsor's protocol ID
- HTI-003
- Status last verified
- Mar 2024
- First submitted
- 21 Aug 2020
- Last updated
- 15 Mar 2024
- Results posted
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Oral Nutritional Supplement for Effect on Total High-Density Lipoprotein (HDL) Cholesterol, HDL Functionality, Particle Size and Number
- ClinicalTrials.gov ID
- NCT04529174
- Acronym / sponsor ID
- HTI-003
- Conditions
- HDL
- Keywords
- HDL cholesterol, HDL function, HDL particle, Dietary supplement, Nutraceutical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Metagenics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 27 Aug 2020 (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.
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized double-blind Placebo controlled trial. Dietary
| Arm | Type | Receives |
|---|---|---|
| Active HDL supplement | Active comparator | Dietary Supplement: CardioLux™HDL25 subjects (ages 18-85 years old) will receive an active HDL supplement (CardioLux™HDL). They will take 2 capsules twice a day with food for 12 weeks. Total daily dosing is four (4) capsules. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo25 randomly selected subjects (ages 18-85 years old) will receive a matching Placebo. They will take 2 capsules twice each day with food for 12 weeks. Total daily dosing is four (4) capsules. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- Pregnant females
- Females of childbearing age not on an accepted contraception control method
- Previous myocardial infarction within 5 years
- Unstable angina
- Previous stroke or TIA within 5 years
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 |
|---|---|---|
| CardioLux™HDLEnrollment will occur according to the inclusion/ exclusion criteria and after the review and signing of the Informed Consent form. Clinical testing will be performed at baseline and each visit (2, 3). Measurement of height, weight with body composition analysis, body mass index, waist circumference, and vital signs (blood pressure, heart rate) will be measured. Review of medical history and current medications by clinician; and collection of fasting blood for testing of the complete blood count (CBC), comprehensive metabolic profile (CMP), as well as a urine pregnancy test in females of child-bearing potential. Visits: Baseline (Visit 1), Week 6 (Visit 2) and Week 12 (Visit 3/End of Study) | Dietary supplement | Active HDL supplement |
| PlaceboEnrollment will occur according to inclusion /exclusion criteria and after the review and signing of the Informed Consent form. Clinical testing will be performed at baseline and each visit (2, 3). Measurement of height, weight with body composition analysis, body mass index, waist circumference, and vital signs (blood pressure, heart rate) will be measured. Review of medical history and current medications by clinician; and collection of fasting blood for testing of the complete blood count (CBC), comprehensive metabolic profile (CMP), as well as a urine pregnancy test in females of child-bearing potential. Visits: Baseline (Visit 1), Week 6 (Visit 2) and Week 12 (Visit 3/End of Study) | Dietary supplement | Placebo |
Primary outcome
HDL-FX test HDL-FX test
Time frame: Change from Baseline to End of Study (week 12)
Reverse Cholesterol Transport (RCT)(CEC) with Cleveland Heart Lab (CHL)
HDL mapping
Time frame: Change from Baselineto End of study (week 12)
HDL mapping with Boston Heart Lab (BHL)
3 secondary outcomes
Myloperoxidase (MPO)
Time frame: Change from Baseline to End of Study (week 12)
LP-PLA-2 test
Time frame: Change from Baseline to End of Study (week 12)
Dietary Intake
Time frame: Change from Baseline to End of Study (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- 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 CardioLux™HDL in people with HDL, 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 15 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HDL-FX test HDL-FX test (time frame: Change from Baseline to End of Study (week 12)). The study lists 2 primary outcomes in all. 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 15 Mar 2024.