[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100314378":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Subjects randomized to the control olive oil arm will take the equivalent to 3g of control \u002Fday in two divided doses (4 capsules a day) for 8 +\u002F- 2weeks and cross-over to the palmitoleate-rich oil",[13],"Drug: control olive oil (COO)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2","Subjects randomized to the control olive oil arm will take the equivalent to 3g of control \u002Fday in two divided doses (4 capsules a day) for 8 +\u002F- 2 weeks and cross-over to the palmitoleate-rich oil arm will take the equivalent to 3g of control \u002Fday in two divided doses (4 capsules a day) for 8 +\u002F- 2 weeks and cross-over to the control olive oil",[18],"Drug: palmitoleate-rich oil (PLO)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","control olive oil (COO)","2 capsules, 2 times a day after meals in a total of 4 capsules a day",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"palmitoleate-rich oil (PLO)",[15],[30],{"name":31,"affiliation":32,"role":33},"Marcelo J Amar, M.D.","National Heart, Lung, and Blood Institute (NHLBI)","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Joy Lynne V Freeman","CONTACT","(301) 480-7632","joylynne.freeman@nih.gov",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-77.10026,38.98067,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":59,"email":60},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","800-411-1222","TTY dial 711","ccopr@nih.gov",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100314378","phase-2-dietary-omega-7-palmitoleic-acid-rich-oil-on-lipoprotein-metabolism-and-satiety-in-adults-100314378",false,"NCT03372733","Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults","Effect of Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults","* INCLUSION CRITERIA:\n* Male and female participants 18 years of age or above.\n* Subject must be healthy, with no known history of cardiovascular disease.\n* 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.\n* Subject understands protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.\n* Subjects with triglyceride levels above 100 mg\u002FdL\n\nEXCLUSION CRITERIA:\n\n* Pregnancy, planned pregnancy (within the study period), or women currently breastfeeding.\n* 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\n* Subjects with weight changes greater than 20% over the past 3 months.\n* Subjects planning a significant change in diet or exercise levels.\n* 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.\n* Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n* 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.\n* 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.\n* Subjects being treated with tamoxifen, estrogens, or progestins that have not been stable for \\>4 weeks.\n* Subjects initiating new medications or patients on multiple medications may also be excluded according to investigator discretion.\n* Anticipated surgery during the study period.\n* Liver enzymes (AST or ALT) levels above 3x upper limit of normal.\n* Blood donation in the last 2 weeks or planned blood donation during the study.\n* Subjects requiring regular transfusions for any reason.\n* 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.\n* Abnormal baseline laboratory values that are considered not clinically significant by the PI will not exclude the subject.",true,"ALL","18 Years","99 Years",{"count":75,"type":76},110,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","Background:\n\nOmega-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.\n\nObjective:\n\nTo study how oil enriched with palmitoleic acid (Omega-7 oil) affects metabolism.\n\nEligibility:\n\nHealthy adults at least 18 years old with no known history of cardiovascular disease.\n\nSubjects not allergic to fish oil and fish products\n\nFemales that are not pregnant and are not planning a pregnancy during the length of the study\n\nDesign:\n\nParticipants will be screened with questions about their health, medical history, and medicines they take.\n\nParticipants will have 4 visits over 24 weeks. The visits may include:\n\n* Blood drawn from a vein in the arm by a needle stick. Sometimes participants will have to fast before the blood draw.\n* Vital signs (blood pressure, heart rate, and temperature) taken\n* Body mass index measured\n* 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.\n* Optional stool samples\n* Pregnancy test\n* A short review of participants physical activity and diet\n* A supply of dietary supplements to take between visits. Participants will take 4 gel capsules a day.\n\nParticipants will keep a food and exercise journal\n\nCompensation will be provided to subjects that complete the study\n\nCheck your eligibility for this study by clicking here: https:\u002F\u002Fwww.surveymonkey.com\u002Fr\u002FDietaryOmega",[82],"Cardiovascular Disease",[84,85,86,87,88],"Omega-7","Palmitoleic Acid","Monounsaturated Fatty Acids","Lipoproteins","Satiety","2026-06-10",{"date":91,"type":92},"2026-06-11","ACTUAL",{"date":94,"type":92},"2018-07-31",{"date":96,"type":76},"2026-07-31",{"name":32,"class":6},1]