Effects of Omega-7 Oil on Heart Health and Hunger in Adults
Effect of Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults
This study is testing whether omega-7 oil can help healthy adults improve their cholesterol levels and feel fuller, which might lower their risk of heart disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03372733 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of palmitoleic acid-rich oil on lipoprotein metabolism and satiety in healthy adults. Participants will be randomly assigned to receive either the omega-7 oil or a control olive oil over a 24-week period, with assessments including blood tests and vital signs. The study aims to determine if palmitoleic acid can improve cholesterol profiles and influence feelings of fullness, potentially reducing cardiovascular disease risk. The trial is designed as a pilot, randomized, double-blinded, crossover study to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older with no history of cardiovascular disease.
Not a fit: Patients with known allergies to fish or omega-7 products, or those with significant weight fluctuations, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new dietary recommendations for improving heart health and managing weight.
How similar studies have performed: Previous studies have indicated potential benefits of omega-7 fatty acids, but this specific approach is novel and has not been extensively tested in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Marcelo J Amar, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Joy Lynne V Freeman
- Email: joylynne.freeman@nih.gov
- Phone: (301) 480-7632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.