About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Crossover
Treatments tested in this trial
control olive oil (COO)
Drug2 capsules, 2 times a day after meals in a total of 4 capsules a day
palmitoleate-rich oil (PLO)
Drug2 capsules, 2 times a day after meals in a total of 4 capsules a day
Treatment groups
Trial outcomes
Primary outcomes
changes in the LDL-cholesterol levels
The primary outcome measures of this study will be changes in the LDL-cholesterol levels. Secondary outcome measurements will be changes in TC, TG, HDL-C, and other lipids, lipoprotein particle number, HDL functional test (i.e. efflux study) composition and size, changes in appetite and/or satiety. Each subject will serve as their own control.
Secondary outcomes
changes in TC, TG, HDL-C, and other lipids, lipoprotein particle number, HDL functional test (i.e. efflux study) composition and size, changes in appetite and/or satiety
Sponsors and contacts
Click on the lead sponsor to view all of their trials.