Omega-7 Rich Oil for Cardiovascular Health
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants stop taking certain supplements or medications that affect lipoproteins, such as fish oil supplements, statins, and others, for at least 8 weeks before joining. If you are on these or similar medications, you may need to stop them to participate.
What data supports the effectiveness of Omega-7 Rich Oil for cardiovascular health?
How is Palmitoleate-Rich Oil (PLO) different from other cardiovascular treatments?
Palmitoleate-Rich Oil (PLO) is unique because it is rich in omega-7 fatty acids, which are less commonly discussed compared to omega-3 and omega-6 fatty acids that are typically found in fish and vegetable oils. This makes PLO a novel option for cardiovascular health, potentially offering benefits through a different mechanism than the more widely studied omega-3 and omega-6 fatty acids.678910
What is the purpose of this trial?
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 this oil is good for heart health. Researchers want to find out more about these potential benefits.Objective:To study how oil enriched with palmitoleic acid (Omega-7 oil) affects metabolism.Eligibility:Healthy adults at least 18 years old with no known history of cardiovascular disease.Subjects not allergic to fish oil and fish productsFemales that are not pregnant and are not planning a pregnancy during the length of the studyDesign:Participants will be screened with questions about their health, medical history, and medicines they take.Participants will have 4 visits over 24 weeks. The visits may include:* Blood drawn from a vein in the arm by a needle stick. Sometimes participants will have to fast before the blood draw.* Vital signs (blood pressure, heart rate, and temperature) taken* Body mass index measured* Cardio-Ankle Vascular Index test may be performed. The stiffness of the participant s arteries will be measured by reading blood pressure in the arms and legs and monitoring the heart.* Optional stool samples* Pregnancy test* A short review of participants physical activity and diet* A supply of dietary supplements to take between visits. Participants will take 4 gel capsules a day.Participants will keep a food and exercise journalCompensation will be provided to subjects that complete the studyCheck your eligibility for this study by clicking here: https://www.surveymonkey.com/r/DietaryOmega
Research Team
Marcelo J Amar, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria
Healthy adults over 18 without cardiovascular disease can join this study. Participants should not be allergic to fish products, pregnant, or planning pregnancy. Women must use birth control if of childbearing potential. Those with stable triglyceride levels above 100mg/dL are eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either control olive oil or palmitoleate-rich oil for 8-10 weeks, followed by a crossover to the other oil for another 8-10 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Control Olive Oil (COO)
- Palmitoleate-Rich Oil (PLO)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor