Omega-7 Rich Oil for Cardiovascular Health

Overseen By Joy Lynne V Freeman

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Must not be taking: Fish oil, Statins, Niacin, others

Disqualifiers: Cardiovascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 16-20 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a special oil rich in omega-7 fatty acids, particularly palmitoleic acid, affects metabolism and potentially benefits heart health. Participants will take either a palmitoleic-rich oil (Palmitoleate-Rich Oil, PLO) or a control olive oil in capsule form, switching between them halfway through the study. The trial seeks healthy adults with no history of heart disease who aren't allergic to fish oil or fish products. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important heart health research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that palmitoleic acid, a type of omega-7 fatty acid, is generally safe and may benefit heart health. Studies have found that oils high in omega-7, such as those rich in palmitoleic acid, do not increase heart disease risk when included in a balanced diet. Participants in previous studies have tolerated these oils well, with few side effects reported. Since this trial is in Phase 2, earlier studies have already assessed safety, indicating that palmitoleic acid is likely well-tolerated by healthy adults. However, as with any treatment, rare side effects might occur, so ongoing monitoring during the trial remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cardiovascular health?

Researchers are excited about Palmitoleate-Rich Oil (PLO) for cardiovascular health because it offers a unique approach by harnessing the power of omega-7 fatty acids, specifically palmitoleic acid. Unlike traditional treatments that often focus on lowering cholesterol or blood pressure, PLO targets inflammation and insulin sensitivity, which are key contributors to heart disease. This novel mechanism could provide additional benefits and a new avenue for patients who may not fully respond to standard therapies like statins. Additionally, PLO is derived from a natural source, giving it an edge for those seeking alternative or complementary treatments.

What evidence suggests that this trial's treatments could be effective for cardiovascular health?

Research shows that palmitoleic acid, a type of omega-7 fatty acid, may benefit heart health. In animal studies, diets high in palmitoleic acid significantly reduced fat buildup in arteries and improved fat metabolism. For example, one NIH study found that omega-7 oil reduced arterial fat buildup by 45% and lowered high blood fat levels by 30% in mice. These findings suggest that palmitoleic acid might help keep arteries clear and support a healthier heart. While most evidence comes from animal studies, these results are promising for potential heart health benefits in humans. Participants in this trial will receive either Palmitoleate-Rich Oil (PLO) or Control Olive Oil (COO) to further investigate these potential benefits in humans. ^{3 5 6 7 8}

Who Is on the Research Team?

Marcelo J Amar, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

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

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

I am using effective birth control and am not breastfeeding.

Exclusion Criteria

I have a condition affecting how my intestines absorb fat.

My weight has changed by more than 20% in the last 3 months.

Liver enzymes (AST or ALT) levels above 3x upper limit of normal

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Omega-3 polyunsaturated fatty acids (n-3 PUFAs), found in fish oils and certain plants, play a significant role in preventing coronary heart disease, with evidence from randomized secondary prevention trials showing comparable risk reductions to those achieved with lipid-lowering medications.

The cardioprotective effects of n-3 PUFAs may be due to mechanisms such as antiarrhythmic and antithrombotic properties, highlighting their potential as a beneficial dietary intervention for heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond the Mediterranean diet: the role of omega-3 Fatty acids in the prevention of coronary heart disease. Harper, CR., Jacobson, TA.[2019]

In a study of 4949 men and women aged 40-79, different dietary methods for assessing fish and fish-oil intake showed no significant differences in their relation to plasma n-3 PUFA levels, indicating that these methods are equally valid.

Women had significantly higher plasma n-3 PUFA concentrations than men, and those consuming fish oil had 20% higher levels than non-consumers, suggesting that sex and fish oil consumption are important factors in n-3 PUFA levels, which only partially explain variations in cardiovascular health outcomes.

NCBI (Pubmed)

pubmed.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. Welch, AA., Bingham, SA., Ive, J., et al.[2023]

The American Heart Association recommends increasing the intake of long-chain omega-3 fatty acids to about 500 mg per day for cardiovascular health, emphasizing their benefits in reducing cardiac risk.

Contrary to popular belief, the AHA advises maintaining or even increasing omega-6 fatty acid intake, suggesting that both omega-3 and omega-6 fatty acids are important for the prevention and treatment of coronary heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-6 and omega-3 fatty acids: partners in prevention. Harris, W.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fish-oil paradox. Nicholls, SJ., Nelson, AJ.[2021]

Out of 493 fish oil products analyzed, only 2 (0.9%) provided the recommended 2,000 mg of EPA and DHA per serving, indicating that most products do not contain sufficient amounts for cardiovascular benefits.

The average EPA and DHA content per serving was 697 mg, requiring an average of 5 servings to reach the beneficial dose, highlighting the need for guidance from healthcare professionals to ensure effective use of fish oil supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Omega-3 Fatty Acid Content in Fish Oil Products. Ward, ED., Thomasson, K., Fischer, KR.[2022]

A first-in-human trial with 30 healthy adults showed that saury fish oil, rich in omega-11 long-chain monounsaturated fatty acids, is safe and significantly lowers LDL particle counts by 12% compared to control oil.

Saury oil also positively affects cardiovascular health by increasing HDL particle size and improving triglyceride levels, while the control oil was associated with an increase in LDL cholesterol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation with saury oil, a fish oil high in omega-11 monounsaturated fatty acids, improves plasma lipids in healthy subjects. Yang, ZH., Amar, M., Sorokin, AV., et al.[2023]

In a study using low-density lipoprotein receptor knockout and apolipoprotein E(-/-) mice, omega-3 fatty acids from fish oil and echium oil significantly reduced atherosclerosis by 40% to 70% and decreased harmful Ly6C(hi) monocyte levels by about 50%.

Omega-3 fatty acids were shown to alter monocyte subsets and reduce their trafficking into atherosclerotic lesions, indicating a mechanism of action that is independent of plasma cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids ameliorate atherosclerosis by favorably altering monocyte subsets and limiting monocyte recruitment to aortic lesions. Brown, AL., Zhu, X., Rong, S., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids: role in cardiovascular health and disease. Engler, MM., Engler, MB.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Omega-3 polyunsaturated fatty acids, found in fish oil and plant sources, have been shown to significantly lower serum triglycerides and improve heart health without adverse effects, making them a safe option for cardiovascular health.

These fatty acids also provide additional benefits such as lowering blood pressure, enhancing endothelial function, and exhibiting anti-inflammatory properties, which are linked to changes in gene expression that regulate key molecules involved in heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Omega-3 polyunsaturated fatty acids in the prevention of atherosclerosis]. Varga, Z.[2013]

Citations

1. cc.nih.gov cc.nih.gov/recruit/protocols/18_cardiovascular

Effect of Dietary Omega-7 Palmitoleic Acid-Rich Oil on ... Palmitoleic acid is one of the most common omega-7 fatty acids. Many studies suggest that this oil is good for heart health.

2. withpower.com withpower.com/trial/phase-3-cardiovascular-diseases-6-2018-8418d

Omega-7 Rich Oil for Cardiovascular Health 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6584074/

Dietary palmitoleic acid attenuates atherosclerosis ... Dietary supplemented palmitoleate reduces atherosclerosis development in LDLR-KO mice, and was associated with improvement of lipid and glucose metabolism.

4. nutritionaloutlook.com nutritionaloutlook.com/view/omega-7-palmitoleic-acid-reduces-atherosclerosis-development-new-nih-animal-study

Omega-7 palmitoleic acid reduces atherosclerosis ... They noted that “our data showed that [the] palmitoleate-rich diet reduced atherosclerotic plaque areas and hyperlipidemia in LDLR-KO mice, ...

5. nutraingredients-usa.com nutraingredients-usa.com/Article/2019/06/20/NIH-study-supports-potential-of-Omega-7-for-heart-health-and-glucose-metabolism/

NIH study supports potential of Omega-7 for heart health ... The NIH scientists report that supplementation of a standard murine diet with omega-7 oil led to a 45% reduction in atherosclerotic lesions and 30% reductions ...

6. clinicalstudies.info.nih.gov clinicalstudies.info.nih.gov/protocoldetails.aspx?id=18-H-0019&&query=Female

Effect of Dietary Omega-7 Palmitoleic Acid-Rich Oil ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4365303/

Palm oil and the heart: A review - PMC Palm oil consumed as a dietary fat as a part of a healthy balanced diet does not have incremental risk for cardiovascular disease. Little or no additional ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S175646461930444X

A review of biological functions, health benefits, and ... Palmitoleic acid, also known as (9Z)-hexadec-9-enoic acid, is an omega-7 monounsaturated fatty acid that is known to exhibit multiple biological functions.