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Information provided by:
Metagenics, Inc.
Last updated:
04/06/2022
Trial identifier:
NCT04529174
DisclaimerStudy Description
Brief summary:
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
Official Title
Glossary term:
Title
The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.
Glossary term:
Evaluation of an Oral Nutritional Supplement for Effect on Total High-Density Lipoprotein (HDL) Cholesterol, HDL Functionality, Particle Size and Number
Type of Study
Glossary term:
Study Type
Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study.
Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Glossary term:
Interventional
Enrollment (Actual)
Glossary term:
Enrollment
The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.
Glossary term:
53
Phase
Glossary term:
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics.
There are five phases:
Early Phase 1 (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
Phase 1: Clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.
Phase 2: Clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Phase 3: Clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Phase 4: Clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.
Not Applicable: Trials without FDA-defined phases, including trials of devices or behavioral interventions.
Glossary term:
Not Applicable
Other Study ID Numbers
Glossary term:
Other study IDs
Identifiers or ID numbers other than the NCT number that are assigned to a clinicalstudy by the study's sponsor, funders, or others. These numbers may include unique identifiers from othertrial registries and National Institutes of Health grant numbers.
Glossary term:
HTI-003
Intervention / Treatment
Glossary term:
Intervention/treatment
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Glossary term:
Dietary Supplement: CardioLux™HDL
Dietary Supplement: Placebo
Study Start (Actual)
Glossary term:
Study start date
The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.
Glossary term:
Aug 18, 2020
Primary Completion (Actual)
Glossary term:
Primary completion date
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.
Glossary term:
Apr 30, 2021
Study Completion (Anticipated)
Glossary term:
Study completion date
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.
Glossary term:
Dec 30, 2022
First Submitted Date
Glossary term:
First submitted
The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
Glossary term:
Aug 21, 2020
First Submitted that Met QC Criteria
Glossary term:
First submitted that met QC criteria
The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
Glossary term:
Aug 25, 2020
First Posted (Actual)
Glossary term:
First posted
The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
Glossary term:
Aug 27, 2020
Last Update Submitted that Met MQ Criteria
Glossary term:
Last update submitted that met QC criteria
The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
Glossary term:
Apr 04, 2022
Last Update Posted (Actual)
Glossary term:
Last update posted
The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date)and the last update posted date.
Glossary term:
Apr 06, 2022
Contacts and Locations
Locations (1)
Hypertension Institute
Nashville, Tennessee, United States, 37205
Contacts and Locations
Locations (1)
Hypertension Institute
Nashville, Tennessee 37205
United States
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. For general information about clinical research, read Guides to Clinical Trials.
Eligibility Criteria
Ages Eligible for Study:
Glossary term:
Age
A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups:
The age groups are:
Child (birth–17)
Adult (18–64)
Older adult (65+)
Glossary term:
18 Years - 85 Years
Accepts Healthy Volunteers:
Glossary term:
Accepts Healthy Volunteers
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.
Glossary term:
No
Sexes Eligible for Study:
Glossary term:
Sex
A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.
Glossary term:
All
Description:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
How is the study designed?
Design Details:
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel Assignment
Interventional Model Description:
Randomized double-blind Placebo controlled trial. Dietary
Number of Arms:
2
Arms and Interventions:
Participant Group / Arm
Glossary term:
Arm
A group or subgroup of participants in a clinical trial that receives a specificintervention/treatment, or no intervention, according to the trial's protocol.
Glossary term:
Intervention / Treatment
Glossary term:
Intervention/treatment
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Glossary term:
Active Comparator: Active HDL supplement
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.
Active Comparator: Active HDL supplement
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
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)
Dietary Supplement: CardioLux™HDL
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)
Placebo Comparator: Placebo
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.
Placebo Comparator: Placebo
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 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
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)
What is the study measuring?
Primary Outcome Measures
Glossary term:
Primary outcome measure
In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Glossary term:
Outcome Measure
HDL-FX test HDL-FX test
Measure Description
Reverse Cholesterol Transport (RCT)(CEC) with Cleveland Heart Lab (CHL)
Timeframe
Change from Baseline to End of Study (week 12)
Outcome Measure
HDL mapping
Measure Description
HDL mapping with Boston Heart Lab (BHL)
Timeframe
Change from Baselineto End of study (week 12)
Outcome Measure
Measure Description
Timeframe
HDL-FX test HDL-FX test
Reverse Cholesterol Transport (RCT)(CEC) with Cleveland Heart Lab (CHL)
Change from Baseline to End of Study (week 12)
HDL mapping
HDL mapping with Boston Heart Lab (BHL)
Change from Baselineto End of study (week 12)
Secondary Outcome Measures
Glossary term:
Secondary outcome measure
In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Glossary term:
Outcome Measure
Myloperoxidase (MPO)
Measure Description
measured with Quest Lab test
Timeframe
Change from Baseline to End of Study (week 12)
Outcome Measure
LP-PLA-2 test
Measure Description
Measured with Quest Lab test
Timeframe
Change from Baseline to End of Study (week 12)
Outcome Measure
Dietary Intake
Measure Description
24 hour recall
Timeframe
Change from Baseline to End of Study (week 12)
Outcome Measure
Measure Description
Timeframe
Myloperoxidase (MPO)
measured with Quest Lab test
Change from Baseline to End of Study (week 12)
LP-PLA-2 test
Measured with Quest Lab test
Change from Baseline to End of Study (week 12)
Dietary Intake
24 hour recall
Change from Baseline to End of Study (week 12)
Sponsor and Collaborators
The Sponsor of a study is the organization or person that is conducting the study. They may provide resources needed to do the investigation.
Sponsor:
Glossary term:
Sponsor
The organization or person who initiates the study and who has authority and control over the study.
Glossary term:
- Metagenics, Inc.
Investigators and Collaborators
Investigators and Collaborators
Investigators:
Glossary term:
Investigator
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
Glossary term:
Central Contacts:
Overall Officials:
- Mark Houston, MD
Collaborators:
Glossary term:
Collaborator
An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Glossary term:
More Information
Publications
Publications of Study Results
General Publications
Publications Automatically Indexed to this Study by ClinicalTrials.Gov Identifier (NCT Number
No publications available
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