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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT03372733
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cardiovascular Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • control olive oil (COO) — DRUG
    2 capsules, 2 times a day after meals in a total of 4 capsules a day
  • palmitoleate-rich oil (PLO) — DRUG
    2 capsules, 2 times a day after meals in a total of 4 capsules a day

Study Details

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

Key Dates

Start date
Jul 31, 2018
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1
    Subjects randomized to the control olive oil arm will take the equivalent to 3g of control /day in two divided doses (4 capsules a day) for 8 +/- 2weeks and cross-over to the palmitoleate-rich oil
  • Experimental: Group 2
    Subjects randomized to the control olive oil arm will take the equivalent to 3g of control /day in two divided doses (4 capsules a day) for 8 +/- 2 weeks and cross-over to the palmitoleate-rich oil arm will take the equivalent to 3g of control /day in two divided doses (4 capsules a day) for 8 +/- 2 weeks and cross-over to the control olive oil

Primary Outcome Measure

changes in the LDL-cholesterol levels [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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