RecruitingPhase 2

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

United States110 participantsStarted 2018-07-31

Plain-language 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

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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…

What they're measuring

changes in the LDL-cholesterol levels

Timeframe: 24 weeks

Trial details

NCT IDNCT03372733

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2026-07-31

Contact for this trial

Joy Lynne V Freeman

(301) 480-7632 joylynne.freeman@nih.gov