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

NCT03372733 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

DRUG

control olive oil (COO)

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

DRUG

palmitoleate-rich oil (PLO)

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

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Marcelo J Amar, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03372733 on ClinicalTrials.gov