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Dietary Omega-7 Palmitoleic Acid-Rich Oil for Lipoprotein Metabolism and Satiety

This study is looking into how an oil rich in omega-7 palmitoleic acid (PLO) affects your body's metabolism and feelings of fullness. Researchers want to see if PLO can improve heart health by changing levels of cholesterol, specifically LDL-cholesterol (often called "bad" cholesterol). You could be eligible if you are a healthy adult, aged 18 to 99, with no history of heart disease. The study will compare PLO to control olive oil (COO). Success for this study would mean seeing a positive change in LDL-cholesterol levels after 24 weeks. The current status of this study is unclear.

Study design
This interventional study plans to enroll 110 participants. It compares two interventions: control olive oil (COO) and palmitoleate-rich oil (PLO).
What's involved
You would take 2 capsules of either COO or PLO, twice a day after meals, for a total of 4 capsules daily. The primary endpoint is measured at 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, changes in LDL-cholesterol levels, is measured at 24 weeks.

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NCT03372733

Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults

Recruiting
PHASE2Ages 18–99InterventionalBasic science
National Heart, Lung, and Blood Institute (NHLBI)
~110 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:control olive oil (COO)palmitoleate-rich oil (PLO)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
changes in the LDL-cholesterol levels
Measured over 24 weeks

Conditions

Cardiovascular Disease

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Marcelo J Amar, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)

Who to contact

Joy Lynne V Freeman
[email protected]
(301) 480-7632
Email the study team

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Eligibility criteria

Inclusion

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.
Subjects with triglyceride levels above 100 mg/dL

Exclusion

Pregnancy, planned pregnancy (within the study period), or women currently breastfeeding.
Subjects 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
Subjects with weight changes greater than 20% over the past 3 months.
Subjects planning a significant change in diet or exercise levels.
Subjects 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.
Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.
Subjects 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.
Subjects 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 inhibitors.
Subjects being treated with tamoxifen, estrogens, or progestins that have not been stable for \>4 weeks.
Subjects 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.
Subjects requiring regular transfusions for any reason.
Subjects 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.

What this trial measures

  • changes in the LDL-cholesterol levels24 weeks

    The primary outcome measures of this study will be changes in the LDL-cholesterol levels. Secondary outcome measurements will be changes in TC, TG, HDL-C, and other lipids, lipoprotein particle number, HDL functional test (i.e. efflux study) composition and size, changes in appetite and/or satiety. Each subject will serve as their own control.