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

NCT03372733 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 18001918-H-0019
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cardiovascular Disease

Keywords

Omega-7; Palmitoleic Acid; Monounsaturated Fatty Acids; Lipoproteins; Satiety

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (1)

• 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

  24 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: control olive oil (COO)

Group 2

EXPERIMENTAL

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

Drug: palmitoleate-rich oil (PLO)

Interventions

control olive oil (COO) DRUG

2 capsules, 2 times a day after meals in a total of 4 capsules a day

Group 1

palmitoleate-rich oil (PLO) DRUG

2 capsules, 2 times a day after meals in a total of 4 capsules a day

Group 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects with triglyceride levels above 100 mg/dL

You may not qualify if:

• 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 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.
• 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 assessment.
• 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 or for not complying with protocol directions.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page
• https://www.surveymonkey.com/r/DietaryOmega

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Marcelo J Amar, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joy Lynne V Freeman

CONTACT

(301) 480-7632; joylynne.freeman@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 14, 2017
• Study Start: July 31, 2018
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04-08

Locations

US (1)