Status:
RECRUITING
Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
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. Many studies suggest that thi...
Detailed Description
Serum cholesterol is transported by lipoproteins, such as VLDL, LDL, and HDL, which vary in their relationship to cardiovascular disease risk. LDL, for example, is proatherogenic, whereas HDL is cardi...
Eligibility Criteria
Inclusion
- INCLUSION 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.
- Subjects with triglyceride levels above 100 mg/dL
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
July 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03372733
Start Date
July 31 2018
End Date
July 31 2026
Last Update
December 8 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892