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New treatment option for Cardiovascular Disease
Official title Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults
ClinicalTrials.gov ID: NCT03372733
What this study is testing
What is control olive oil (COO)?
control olive oil (COO) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cardiovascular disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Omega-7 fatty acids are found in the oil extracted from certain fish and nuts like macadamia. Palmitoleic acid is one of the most common omega-7 fatty acids.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99. Healthy volunteers may be eligible.
You may be able to join if
- Male and female participants 18 years of age or above.
- Subject must be healthy, with no known history of cardiovascular disease.
- Post-menopausal or women of childbearing potential must be non-lactating and using an effective form of birth control during the course of the study.
- Subject understands protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.
- people with triglyceride levels above 100 mg/dL
You likely can't join if
- Pregnancy, planned pregnancy (within the study period), or women currently breastfeeding.
- people with allergy or known hypersensitivity to fish, omega-3-acid ethyl esters, omega-7 ethyl esters, other related drugs, or any component of...
- people with weight changes greater than 20% over the past 3 months.
- people planning a significant change in diet or exercise levels.
- people already consuming more than 2 g per day of MUFA, PUFA or other forms of fatty acid supplement if determined by the investigator as having a...
- people with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect...
See the full eligibility criteria
- Male and female participants 18 years of age or above.
- Subject must be healthy, with no known history of cardiovascular disease.
- Post-menopausal or women of childbearing potential must be non-lactating and using an effective form of birth control during the course of the study.
- Subject understands protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.
- people with triglyceride levels above 100 mg/dL
- Pregnancy, planned pregnancy (within the study period), or women currently breastfeeding.
- people with allergy or known hypersensitivity to fish, omega-3-acid ethyl esters, omega-7 ethyl esters, other related drugs, or any component of study drugs
- people with weight changes greater than 20% over the past 3 months.
- people planning a significant change in diet or exercise levels.
- people already consuming more than 2 g per day of MUFA, PUFA or other forms of fatty acid supplement if determined by the investigator as having a potential to interfere in the data quality or patient safety.
- people with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.
- people with any acute and life-threatening condition, such but not limited to as prior sudden cardiac arrest, acute myocardial infarction (last three months), stroke, embolism as per investigator assessment.
- people taking supplements or medications that affect lipoproteins for at least the past 8 weeks, such as fish oil supplements, bile-acid sequestrants, plant sterol supplements, fibrates, statins, Niacin or PCSK9...
- people being treated with tamoxifen, estrogens, or progestins that have not been stable for \>4 weeks.
- people initiating new medications or patients on multiple medications may also be excluded according to investigator discretion.
- Anticipated surgery during the study period.
- Liver enzymes (AST or ALT) levels above 3x upper limit of normal.
- Blood donation in the last 2 weeks or planned blood donation during the study.
- people requiring regular transfusions for any reason.
- people may also be excluded for any reason that may compromise their safety or the accuracy of research data or for not complying with protocol directions.
- Abnormal baseline laboratory values that are considered not clinically significant by the PI will not exclude the subject.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.