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

Cardiovascular Disease Clinical Trial

Official title: Effect of Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults

Status Recruiting

Clinical Trial 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

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

• NCT number: NCT03372733
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Joy Lynne V Freeman
• Phone: (301) 480-7632
• Email: joylynne.freeman@nih.gov
• Status: Recruiting
• Phase: Phase 2
• Start date: July 31, 2018
• Completion date: July 31, 2024