Actively Recruiting

Phase 2
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT03372733

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

Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-04-13

110

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female participants 18 years of age or above
  • Healthy with no known history of cardiovascular disease
  • Post-menopausal or women of childbearing potential must be non-lactating and using effective birth control during the study
  • Understands the study protocol and provides written informed consent
  • Triglyceride levels above 100 mg/dL
Not Eligible

You will not qualify if you...

  • Pregnant, planning pregnancy during the study, or currently breastfeeding
  • Allergy or known sensitivity to fish, omega-3 or omega-7 ethyl esters, or any component of study drugs
  • Weight changes greater than 20% over the past 3 months
  • Planning significant changes in diet or exercise
  • Currently taking more than 2 g per day of MUFA, PUFA, or other fatty acid supplements that may interfere with the study
  • Conditions affecting intestinal fat absorption such as chronic diarrhea or gastric bypass
  • Acute or life-threatening conditions like recent cardiac arrest, myocardial infarction, stroke, or embolism
  • Taking medications or supplements affecting lipoproteins in the past 8 weeks
  • Treatment with tamoxifen, estrogens, or progestins not stable for more than 4 weeks
  • Initiating new medications or on multiple medications at investigator discretion
  • Anticipated surgery during the study
  • Elevated liver enzymes above 3 times the upper limit of normal
  • Blood donation in the last 2 weeks or planned during the study
  • Regular transfusions for any reason
  • Any other condition or situation that may compromise safety or data accuracy or noncompliance with protocol directions
  • Abnormal baseline lab values considered clinically insignificant by the investigator will not exclude participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

J

Joy Lynne V Freeman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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