CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
control fish oil +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03043365
NCT03043365Phase 2Completed

Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted Feb 6, 2017·Updated Aug 12, 2020

In Brief

A Phase 2 clinical trial evaluating control fish oil and LCMUFA-rich saury oil for Lipoprotein Metabolism and 2 related conditions. Completed, enrolled 37 participants across 1 site.

Detailed Summary

Background: Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3 fatty acid is the most known fish oil available in the market. LCMUFA (long-chain monounsaturated fatty acids) is also a fish oil but it is derived from fish that consumes a diet rich in omega-11 fatty acid. Researchers want to study omega-11 fatty acid enriched fish oil and understand its effect on cardiovascular health. Objective: To understand the effects of LCMUFA from fish oil on cardiovascular health. Eligibility: Healthy volunteers ages 18 and older with no history of cardiovascular disease Design: Participants will be screened with: * Medical history * Physical exam * Fasting blood and urine tests * Optional stool sample * Questions about their diet, exercise, and the types of medicines and dietary supplements they take * 7-day food diary * Cardio-Ankle Vascular Index (CAVI): Blood pressure is taken in the arms and legs. The heart is monitored. * After the screening visit, participants will take 4 gel capsules, 3 times a day after meals, for 8-10 weeks. * Electrocardiogram (EKG) Participants will have 3 additional visits. All include repeats of the screening tests. Visit 2 is 8 weeks after the screening visit. Participants will stop taking the capsules for 8 weeks after this visit. Visit 3 is at least 16 weeks after starting the supplement. Participants will take 4 capsules, 3 times a day after meals, for 8 weeks after this visit. Visit 4 is 8 weeks after starting the second supplement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 6, 2017
Enrollment StartJun 15, 2017
Primary CompletionMay 29, 2019
Study CompletionNov 21, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.4 years ago

Interventions

control fish oildrug

4 capsules, 3 times a day after meals

LCMUFA-rich saury oildrug

4 capsules, 3 times a day after meals