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Omega-7 Fatty Acid

Omega-7 Rich Oil for Cardiovascular Health

Phase 2
Recruiting
Led By Marcelo J Amar, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be healthy, with no known history of cardiovascular disease
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial is testing the effects of Omega-7 oil on metabolism. Eligible participants will have 4 visits over 24 weeks, during which they will take dietary supplements and keep a food and exercise journal. Compensation is provided for completing the study.

Who is the study for?
Healthy adults over 18 without cardiovascular disease can join this study. Participants should not be allergic to fish products, pregnant, or planning pregnancy. Women must use birth control if of childbearing potential. Those with stable triglyceride levels above 100mg/dL are eligible.Check my eligibility
What is being tested?
The trial is testing the effects of palmitoleic acid-rich oil (Omega-7) on metabolism and satiety compared to olive oil. Over six months, participants will take gel capsules daily, have health checks, provide blood samples, and keep a food/exercise journal.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to omega fatty acids or reactions in those with fish allergies. However, since it's a nutritional supplement study based on oils generally regarded as safe for consumption, significant side effects are not anticipated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am healthy and have no history of heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
changes in the LDL-cholesterol levels
Secondary outcome measures
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
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
Group II: Group 1Experimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,838 Previous Clinical Trials
47,851,544 Total Patients Enrolled
Marcelo J Amar, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
5 Previous Clinical Trials
272 Total Patients Enrolled

Media Library

Palmitoleate-Rich Oil (PLO) (Omega-7 Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT03372733 — Phase 2
Cardiovascular Disease Research Study Groups: Group 1, Group 2
Cardiovascular Disease Clinical Trial 2023: Palmitoleate-Rich Oil (PLO) Highlights & Side Effects. Trial Name: NCT03372733 — Phase 2
Palmitoleate-Rich Oil (PLO) (Omega-7 Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03372733 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an unprecedented research endeavor?

"Presently, 10 PLO trials are operating in 22 urban centres across four countries. Pronova BioPharma's clinical trial for the drug commenced in 2017 with a total of 174 participants and ultimately achieved Phase 3 approval. Subsequent to that study, 32 other tests have been concluded."

Answered by AI

Have researchers conducted other experiments utilizing palmitoleate-rich oil (PLO)?

"Currently, 10 medical studies are underway to investigate the efficacy of palmitoleate-rich oil (PLO). Three of these active clinical trials have reached Phase 3 while the remaining seven remain in Phases 1 and 2. Most PLO investigations are located within Ciudad De Mexico, but there is a total of 30 research sites throughout Mexico."

Answered by AI

Who are the eligible subjects for this research endeavor?

"To qualify for this clinical trial, applicants must be between 18 and 100 years old with a documented cardiovascular disorder. 70 participants will ultimately join the study."

Answered by AI

Is the current research endeavor offering enrollment to individuals of 45 years and older?

"To be included in this trial, potential participants must range between 18 and 100 years old. Separately, there are 33 studies targeting minors and 385 for seniors."

Answered by AI

Has the FDA sanctioned palmitoleate-rich oil (PLO) for human consumption?

"Despite some evidence of safety, due to the Phase 2 trial status there is a lack of efficacy data for palmitoleate-rich oil (PLO), resulting in it obtaining a score of 2."

Answered by AI

Is the opportunity to participate in this experiment still available for eligible individuals?

"Affirmative. According to the records on clinicaltrials.gov, this research project is still seeking patients to participate in the study which was initially published on July 31st 2018 and was recently amended on November 19th 2022. 70 volunteers are required for this single-site trial."

Answered by AI

What is the participant count for this research initiative?

"Affirmative. Data hosted on clinicaltrials.gov reveals that this medical study, which was initially posted in July of 2018, is presently enrolling participants. Approximately 70 individuals are needed to be sourced from 1 site."

Answered by AI

Who else is applying?

What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults
2018. "Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03372733.
~5 spots leftby Jul 2024
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