Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults

• Status: Suspended
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

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 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 products

Females that are not pregnant and are not planning a pregnancy during the length of the study

Design:

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 journal

Compensation will be provided to subjects that complete the study

Check your eligibility for this study by clicking here:

https://www.surveymonkey.com/r/DietaryOmega

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

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 100mg/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.

• Abnormal baseline laboratory values that are considered not clinically significant by the PI will not exclude the subject.