An interventional study of CardioLux™HDL and Placebo in HDL, sponsored by Metagenics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Metagenics, Inc. · Not applicable, Interventional, and Supportive care
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
Metagenics, Inc. is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: CardioLux™HDL
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.
Dietary Supplement: Placebo
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)
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)
HDL-FX test HDL-FX test
Reverse Cholesterol Transport (RCT)(CEC) with Cleveland Heart Lab (CHL)
Time frame: Change from Baseline to End of Study (week 12)
HDL mapping
HDL mapping with Boston Heart Lab (BHL)
Time frame: Change from Baselineto End of study (week 12)
Myloperoxidase (MPO)
measured with Quest Lab test
Time frame: Change from Baseline to End of Study (week 12)
LP-PLA-2 test
Measured with Quest Lab test
Time frame: Change from Baseline to End of Study (week 12)
Dietary Intake
24 hour recall
Time frame: Change from Baseline to End of Study (week 12)
Weight
measured in pounds (Lbs)
Time frame: Change from Baseline to End of Study (week 12)
Body Mass Index
measured in kg/m2
Time frame: Change from Baseline to End of Study (week 12)
Waist Circumference
measured in cm
Time frame: Change from Baseline to End of Study (week 12)
Blood pressure (systolic/diastolic)
measured in mm Hg
Time frame: Change from Baseline to End of Study (week 12)
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2020 to primary completion in Apr 2021, 8 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Huntington Disease-Like 2
Metagenics, Inc.