110 Participants Needed

Omega-7 Rich Oil for Cardiovascular Health

JL
Overseen ByJoy Lynne V Freeman
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

While there is no direct evidence for Omega-7 Rich Oil, omega-3 fatty acids, which are similar, have been shown to improve heart health by lowering bad cholesterol, reducing inflammation, and improving blood vessel function.12345

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

MJ

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

I am using effective birth control and am not breastfeeding.
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 100mg/dL
See 1 more

Exclusion Criteria

My weight has changed by more than 20% in the last 3 months.
I have a condition affecting how my intestines absorb fat.
I am expected to undergo surgery during the study.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

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

16-20 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Control Olive Oil (COO)
  • Palmitoleate-Rich Oil (PLO)
Trial Overview The trial is testing the effects of palmitoleic acid-rich oil (Omega-7) on metabolism and satiety compared to olive oil. Over six months, participants will take gel capsules daily, have health checks, provide blood samples, and keep a food/exercise journal.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Subjects randomized to the control olive oil arm will take the equivalent to 3g of control /day in two divided doses (4 capsules a day) for 8 +/- 2 weeks and cross-over to the palmitoleate-rich oil arm will take the equivalent to 3g of control /day in two divided doses (4 capsules a day) for 8 +/- 2 weeks and cross-over to the control olive oil
Group II: Group 1Experimental Treatment1 Intervention
Subjects randomized to the control olive oil arm will take the equivalent to 3g of control /day in two divided doses (4 capsules a day) for 8 +/- 2weeks and cross-over to the palmitoleate-rich oil

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3,987
Recruited
47,860,000+

Findings from Research

Omega-3 polyunsaturated fatty acids, particularly eicosapentaenoic and docosahexaenoic acids, are crucial for cardiovascular health, supported by substantial evidence from clinical trials.
These fatty acids provide cardioprotective benefits through various mechanisms, including improving lipid profiles, lowering blood pressure, enhancing vascular function, and reducing inflammation.
Omega-3 fatty acids: role in cardiovascular health and disease.Engler, MM., Engler, MB.[2019]
Recent clinical trials indicate that high-dose eicosapentaenoic acid (EPA) may reduce cardiovascular risk, while formulations containing both EPA and docosahexaenoic acid (DHA) or lower doses of omega-3 fatty acids do not show similar benefits.
The variability in cardiovascular outcomes based on the composition and dosage of omega-3 fatty acids suggests that careful consideration is needed in their use for cardiovascular prevention strategies.
The fish-oil paradox.Nicholls, SJ., Nelson, AJ.[2021]
In a study involving 36 hypercholesterolemic participants, both high-oleic rapeseed oil (HOCO) and flaxseed oil (FXCO) significantly reduced LDL-cholesterol levels compared to a typical Western diet, with FXCO showing a greater reduction of 15.1%.
The combination of flaxseed oil not only lowered cholesterol levels but also reduced inflammatory markers like E-selectin, suggesting that FXCO may provide additional cardiovascular benefits beyond lipid-lowering effects.
High-oleic rapeseed (canola) and flaxseed oils modulate serum lipids and inflammatory biomarkers in hypercholesterolaemic subjects.Gillingham, LG., Gustafson, JA., Han, SY., et al.[2018]

References

Omega-3 fatty acids: role in cardiovascular health and disease. [2019]
The fish-oil paradox. [2021]
High-oleic rapeseed (canola) and flaxseed oils modulate serum lipids and inflammatory biomarkers in hypercholesterolaemic subjects. [2018]
Omega-3 fatty acids ameliorate atherosclerosis by favorably altering monocyte subsets and limiting monocyte recruitment to aortic lesions. [2021]
[Omega-3 polyunsaturated fatty acids in the prevention of atherosclerosis]. [2013]
Analysis of Omega-3 Fatty Acid Content in Fish Oil Products. [2022]
Omega-6 and omega-3 fatty acids: partners in prevention. [2022]
Beyond the Mediterranean diet: the role of omega-3 Fatty acids in the prevention of coronary heart disease. [2019]
Supplementation with saury oil, a fish oil high in omega-11 monounsaturated fatty acids, improves plasma lipids in healthy subjects. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Dietary fish intake and plasma phospholipid n-3 polyunsaturated fatty acid concentrations in men and women in the European Prospective Investigation into Cancer-Norfolk United Kingdom cohort. [2023]
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