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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: Recruiting Phase 2 study of Cardiovascular Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
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 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2018-07-31 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
What NCT03372733 shows while recruiting
NCT03372733 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cardiovascular Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03372733's enrollment target sits among peer trials
110 74th of 137 higher than 64 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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