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

  • STATUS
    Recruiting
Updated on 23 November 2020
fatty acids
fish oil

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 30 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. 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
    • Appetite and satiety test. Participants will fast the night before, then answer questions about appetite and feeling full. They will get a light breakfast and then a light lunch.
    • 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

Please visit our Patient Recruitment Page for more information.

 

Description

Serum cholesterol is transported by lipoproteins, such as VLDL, LDL and HDL, which vary in their relationship to cardiovascular disease risk. LDL, for example, is proatherogenic, whereas HDL is cardio-protective. Palmitoleic acid (cis-C16:1 n-7), an omega-7 fatty acid with 16 carbons in length with a single double bound in the n-7 position, have been shown in mice and human to decrease proatherogenic lipoproteins, such as LDL, and reduce cardiovascular risk factors.

This study will test the hypothesis that palmitoleate supplementation in humans will favorably alter the lipoprotein lipid profile in regard to cardiovascular disease risk. We will also assess other parameters related to lipoprotein composition and function, as well as other biomarkers related to coagulation and inflammation, which have previously been shown to be possibly affected by supplementation with omega-7 fatty acid. In addition, previous animal studies have indicated the palmitoleate induced satiety and suppressed bodyweight gain, possibly through enhancement of the release of satiety hormones. In this clinical trial, we, therefore will also examine the effect of concentrated palmitoleate on satiety.

This clinical research project is designed as a pilot, randomized, double-blinded, crossover study that will investigate the effect of concentrated oil enriched with palmitoleate on lipoprotein metabolism and satiety. Subjects will either receive control olive oil enriched in oleic acid, a longer-chain monounsaturated fatty acid (cis-C18:1 n-9), or a concentrate oil supplement produced from pollock fish (rich in palmitoleate) for approximately 8-10 weeks, with a wash out period of 8-10 weeks between the two arms of the study.

The study consists of 4 outpatient visits when laboratory or research samples and CAVI tests will be performed. A 7-day food diary, pill count, and red cell membrane fatty acid levels will be monitored to assess compliance. The effect of the supplement on satiety will be assessed at each visit.

 

Please visit our Patient Recruitment Page for more information.

Details
Condition Cardiovascular Disease
Clinical Study IdentifierTX218181
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

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

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 with BMI equal or below 25 kg/m(2) and/or triglyceride levels equal or below 100 mg/dL at any point
Subjects already consuming more than 2 g per day of MUFA, PUFA or other forms of fatty acid supplement if determined by the inverstigator 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 investigator accessment
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
Subjects being treated with tamoxifen, estrogens, or progestins that have not been stable for >4 weeks
Subjects initiating new medications or patients on multiple medications may also be excluded according to investigator discretion
Anticipated surgery during the study period
Liver enzymes (AST or ALT) levels above 3x upper limit of normal
Blood donation in the last 2 weeks or planned blood donation during the study
Subjects requiring regular transfusions for any reason
Subjects may also be excluded for any reason that may compromise their safety or the accuracy of research data
Abnormal baseline laboratory values that are considered not clinically significant by the PI will not exclude the subject
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