Lipoprotein MetabolismPhase 2NCT03043365
Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults
A Phase 2 study testing LCMUFA-rich saury oil in people with Lipoprotein Metabolism and PCSK9, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipoprotein Metabolism, PCSK9, Proteomics
- What is being tested?
- LCMUFA-rich saury oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 21 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants 18 years of age or above.
- Subject must be healthy, with no known history of cardiovascular disease.
- Pre-menopausal or women of childbearing potential must be non-lactating and using an effective form of birth control during the course of the study.
- Subject understands protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.
Who cannot join
- Pregnancy, planned pregnancy (within the study period) or women currently breastfeeding.
- Subjects with weight changes greater than 20% over the past 3 months.
- Subjects planning a significant change in diet or exercise levels.
- Subjects already consuming more than 1.5 g per day of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) in any form.
- Known sensitivity or allergy to fish, shellfish or omega-3 fatty acids supplements
- Subjects with known bleeding disorders (for example, Hemophilia)
Show all 26Show fewer
- Subjects previously diagnosed with atrial fibrillation
- Subjects with clinically diagnosed hepatic disease (including but not limited to auto immune disease, hepatitis and cirrhosis)
- Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other conditions that could affect intestinal fat absorption
- Subjects with any acute and life-threatening condition, such as prior sudden cardiac arrest, acute myocardial infarction (last three months), stroke, embolism
- Liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) levels above 3x upper limit of normal
- Subjects with a thyroid-stimulating hormone (TSH) greater than 1.5x upper limits of normal (ULN) or clinical evidence of hypo or hyperthyroidism
- Subjects taking supplements or medications that affect lipoproteins for at least the past 8 weeks, such as fish oil supplements, bile-acid sequestrants, plant sterol supplements, fibrates, statins or Niacin.
- Subjects with hemoglobin <10g/dL
- Subject with platelet counts <60x103/microliter
- Subjects with uncontrolled hypertension (resting blood pressure > 160 mmHg systolic and /or > 100 mm Hg diastolic)
- Subject with uncontrolled diabetes (hemoglobin A1c (HbA1c) greater than or equal to 10)
- Subjects who consume excessive alcohol (binge drinking on 5 or more days in the past month)
- Subject participating in other clinical studies and/or receiving other investigational drug products prior to randomization
- Subject taking PCSK9 inhibitors within 8 weeks prior to enrollment
- Subjects being treated with tamoxifen, estrogens, or progestins that have not been stable for >4 weeks.
- Subjects initiating new medications or patients on multiple medications may also be excluded according to investigator discretion
- Anticipated surgery during the study period
- Blood donation in the last 2 weeks or planned blood donation during the study
- Subjects requiring regular transfusions for any reason
- Subjects may also be excluded for any reason that may compromise their safety or the accuracy of research data.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Serum cholesterol is transported by lipoproteins, such as very low-density lipoprotein (VLDL), low-density lipoproteins (LDL) and high-density lipoproteins (HDL), which vary in their relationship to cardiovascular disease risk. LDL, for example, is proatherogenic, whereas HDL is cardio-protective. Long-chain monounsaturated fatty acids (LCMUFA), fatty acids over 18 carbons in length with a single double bond, have been shown in mice to decrease proatherogenic lipoproteins, such as LDL, and reduce atherosclerosis. This study will test the hypothesis that LCMUFA supplementation in humans will favorably alter the lipoprotein lipid profile in regard to cardiovascular disease risk. In addition, we will assess other parameters related to lipoprotein composition and function, as well as other biomarkers related to coagulation and inflammation, which have previously been shown to be affected by supplementation with omega-3 fatty acids.
This clinical research project is designed as a pilot, randomized, double-blinded, crossover study that will investigate the effect of a fish oil enriched with LCMUFA on lipoprotein metabolism. Subjects will receive control fish oil enriched in oleic acid, a monounsaturated fatty acid (C18:1), or a fish oil supplement produced from Saury fish (rich in LCMUFA) for approximately 8-10 weeks, with a wash out period of 8-10 weeks between the two arms of the study. The study consists of 4 outpatient visits when laboratory or research samples and CAVI tests will be performed. A 7-day food diary, pill count, and red cell membrane fatty acid levels will be monitored to assess compliance.
- Conditions
- Lipoprotein Metabolism, PCSK9, Proteomics
- Being tested
- control fish oil, LCMUFA-rich saury oil
- Keywords
- Fish Oils, Long Chain Monounsaturated Fatty Acids (LCMUFA), Lipoproteins, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control fish oilDrug
Also called DHA, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), EPA (fish oils), fish oils, marine oils, N3 fatty acids, omega 3 polyunsaturated fatty acid (PUFA), polyunsaturated fatty acids,, PUFA, W3 fatty acids
4 capsules, 3 times a day after meals
LCMUFA-rich saury oilDrug
Also called long-chain monounsaturated fatty acids
4 capsules, 3 times a day after meals
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Control Fish Oil first, then Saury Oil | Experimental | Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the LCMUFA-rich saury oil capsule arm Receives: Drug: control fish oil |
| Arm 2: Saury Oil first, then Control Fish Oil | Experimental | Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm Receives: Drug: LCMUFA-rich saury oil |
| Washout Period | No intervention | 8 week washout period to occur between week 8 and week 16. No study supplement taken by subject at this time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes From Baseline in Lipid Profile at 8 Weeks
The primary outcome measures of this study will be the change from baseline to end of intervention period (8 weeks) in the lipid profile (total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)) for the control and research supplement groups.
Measured: baseline and 8 weeks
Secondary outcomes (2)
Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)
Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size. Secondary outcome will measure the following: Small dense low density lipoprotein (sdLDL); Low-Density Lipoprotein Triglycerides (LDL-TG); Apolipoprotein E-containing high-density lipoprotein (ApoE-HDL); apolipoprotein A-I (ApoA-I); Apolipoprotein B (ApoB).
Measured: baseline and 8 weeks
Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)
Secondary outcome measurements will be changes in proteomics, lipoprotein particle number, high-density lipoprotein (HDL) functional test (i.e. efflux study) composition and size.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start15 Jun 2017
- Primary completion29 May 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lipoprotein MetabolismStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marcelo J Amar, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043365
- Sponsor's protocol ID
- 170050
- Other IDs
- 17-H-0050
- Status last verified
- Nov 2019
- First submitted
- 3 Feb 2017
- Last updated
- 12 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults
- ClinicalTrials.gov ID
- NCT03043365
- Acronym / sponsor ID
- 170050
- Conditions
- Lipoprotein Metabolism, PCSK9, Proteomics
- Keywords
- Fish Oils, Long Chain Monounsaturated Fatty Acids (LCMUFA), Lipoproteins, Cardiovascular Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Serum cholesterol is transported by lipoproteins, such as very low-density lipoprotein (VLDL), low-density lipoproteins (LDL) and high-density lipoproteins (HDL), which vary in their relationship to cardiovascular disease risk. LDL, for example, is proatherogenic, whereas HDL is cardio-protective. Long-chain monounsaturated fatty acids (LCMUFA), fatty acids over 18 carbons in length with a single double bond, have been shown in mice to decrease proatherogenic lipoproteins, such as LDL, and reduce atherosclerosis. This study will test the hypothesis that LCMUFA supplementation in humans will favorably alter the lipoprotein lipid profile in regard to cardiovascular disease risk. In addition, we will assess other parameters related to lipoprotein composition and function, as well as other biomarkers related to coagulation and inflammation, which have previously been shown to be affected by supplementation with omega-3 fatty acids.
This clinical research project is designed as a pilot, randomized, double-blinded, crossover study that will investigate the effect of a fish oil enriched with LCMUFA on lipoprotein metabolism. Subjects will receive control fish oil enriched in oleic acid, a monounsaturated fatty acid (C18:1), or a fish oil supplement produced from Saury fish (rich in LCMUFA) for approximately 8-10 weeks, with a wash out period of 8-10 weeks between the two arms of the study. The study consists of 4 outpatient visits when laboratory or research samples and CAVI tests will be performed. A 7-day food diary, pill count, and red cell membrane fatty acid levels will be monitored to assess compliance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Control Fish Oil first, then Saury Oil | Experimental | Drug: control fish oilSubjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the LCMUFA-rich saury oil capsule arm |
| Arm 2: Saury Oil first, then Control Fish Oil | Experimental | Drug: LCMUFA-rich saury oilSubjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm |
| Washout Period | No intervention | –8 week washout period to occur between week 8 and week 16. No study supplement taken by subject at this time. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants 18 years of age or above.
- Subject must be healthy, with no known history of cardiovascular disease.
- Pre-menopausal or women of childbearing potential must be non-lactating and using an effective form of birth control during the course of the study.
- Subject understands protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.
Key exclusion criteria (26 listed)
- Pregnancy, planned pregnancy (within the study period) or women currently breastfeeding.
- Subjects with weight changes greater than 20% over the past 3 months.
- Subjects planning a significant change in diet or exercise levels.
- Subjects already consuming more than 1.5 g per day of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) in any form.
- Known sensitivity or allergy to fish, shellfish or omega-3 fatty acids supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control fish oilAlso: DHA, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), EPA (fish oils), fish oils, marine oils, N3 fatty acids, omega 3 polyunsaturated fatty acid (PUFA), polyunsaturated fatty acids,, PUFA, W3 fatty acids4 capsules, 3 times a day after meals | Drug | Arm 1: Control Fish Oil first, then Saury Oil |
| LCMUFA-rich saury oilAlso: long-chain monounsaturated fatty acids4 capsules, 3 times a day after meals | Drug | Arm 2: Saury Oil first, then Control Fish Oil |
Primary outcome
Changes From Baseline in Lipid Profile at 8 Weeks
Time frame: baseline and 8 weeks
The primary outcome measures of this study will be the change from baseline to end of intervention period (8 weeks) in the lipid profile (total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)) for the control and research supplement groups.
2 secondary outcomes
Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)
Time frame: baseline and 8 weeks
Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)
Time frame: baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo J Amar, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LCMUFA-rich saury oil in people with Lipoprotein Metabolism and PCSK9, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes From Baseline in Lipid Profile at 8 Weeks (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.