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NCT03372733 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Cardiovascular Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Recruiting
Registry status
Phase 2
Development phase
110
Enrollment target
1
Study location

NCT03372733 is a Phase 2 study of Cardiovascular Disease that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 110 participants, below the 2,713-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03372733, a Phase 2 study of Cardiovascular Disease, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

RECRUITING
Registry status
Phase 2
Development phase
110 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DRUG control olive oil (COO)
  • DRUG palmitoleate-rich oil (PLO)

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2018-07-31
Est. Completion 2026-07-31
Phase Phase 2

What the Registry Record Tells You About NCT03372733

The ClinicalTrials.gov registry entry for NCT03372733 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,713-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (96% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which control olive oil (COO) is the first listed.

NCT03372733 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT03372733 about?

NCT03372733 is a clinical study titled "Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults". 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. O...

What is the current status of trial NCT03372733?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2018-07-31. Estimated completion is 2026-07-31.

What conditions does trial NCT03372733 study?

This clinical trial studies the following conditions: Cardiovascular Disease.

What interventions are being tested in trial NCT03372733?

The interventions under investigation include: control olive oil (COO) (DRUG), palmitoleate-rich oil (PLO) (DRUG).

Who is sponsoring clinical trial NCT03372733?

This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03372733 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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