HypertriglyceridemiaNCT00804427
Effect of Fish Oil on Plasma Triglycerides in Adults
A study testing Fish oil (90% triglycerides), Fish oil (60% triglycerides) and Fish oil (ethyl esters) in people with Hypertriglyceridemia, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of two types of omega-3 fats from fish oil on plasma triglycerides. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Fish oil (90% triglycerides), Fish oil (60% triglycerides) and Fish oil (ethyl esters)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: > or = 18 years
- Ethnicity and race: All ethnic and racial backgrounds welcome
- Fasting blood triglycerides greater than or equal to 150 mg/dL
- Planning to be available for clinic visits for the 12 weeks of study participation
- Ability and willingness to give written informed consent
- No known active psychiatric illness. Exclusion Criteria:*At screening:
Show all 17Show fewer
- Daily intake of dietary supplements containing omega-3 FAs within the past month.
- Fasting blood glucose greater than or equal to 126 mg/dL
- Self reported personal history of:
- Clinically significant atherosclerosis (e.g., CAD, PAD)
- Malignant neoplasm
- Subjects currently receiving the following medications (self report):
- Lipid lowering drugs including statins
- Anti-hypertensive drugs: beta-blockers and thiazides
- Body Mass Index (BMI) greater than or equal to 40.
- Pregnant or Lactating
- Inability to communicate effectively with study personnel
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults
The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of two types of omega-3 fats from fish oil on plasma triglycerides. The two types of fish oil are composed of (1) omega-3 fatty acids in triglyceride form; and (2) as esterified free fatty acids (i.e. ethyl esters). Although these two types of fish oil supplements are available to the public, it remains unclear whether they are equally effective in lowering plasma triglycerides.
Read the detailed description
This study is a double-blinded, parallel design, placebo controlled trial with three active treatment arms to compare the triglyceride (TG) lowering effects of the same dose of EPA and DHA provided in three formulations of supplements that differ in the proportion of omega-3 FA present as ethyl esters vs. triglycerides. The active therapy for each of the three fish oil supplementation arms is 4 g/day of combined EPA and DHA provided as: a) 90% TG formulation, b) 60% TG formulation, or c) ethyl esters (esterified fatty acids)(i.e., 0% TG). The placebo was a soy oil supplement with an identical total fat content. The primary outcome is the 12-week change in TG concentrations in the active groups vs. placebo. Secondary outcomes include LDL particle distribution, defined as either subclasses LDL1, LDL2, LDL3 and LDL4, and LDL subclass phenotype patterns A, B, or A/B.
- Conditions
- Hypertriglyceridemia
- Being tested
- Fish oil (90% triglycerides), Fish oil (60% triglycerides), Fish oil (ethyl esters), Soy oil
- Keywords
- Fish oil, Triglycerides, Low-density Lipoprotein (LDL) cholesterol, Low-density Lipoprotein (LDL) subclass, Low-density Lipoprotein (LDL) particle size, Low-density Lipoprotein (LDL) phenotype
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil (90% triglycerides)Dietary supplement
Fish oil (60% triglycerides)Dietary supplement
Fish oil (ethyl esters)Dietary supplement
Soy oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Fish oil (90% triglycerides) | Experimental | Fish oil (4 grams/day of combined EPA and DHA) as 90% triglyceride formulation, taken in two divided doses with main meals. Receives: Dietary Supplement: Fish oil (90% triglycerides) |
| Fish oil (60% triglycerides) | Experimental | Fish oil (4 grams/day of combined EPA and DHA) as 60% triglyceride formulation, taken in two divided doses with main meals. Receives: Dietary Supplement: Fish oil (60% triglycerides) |
| Fish oil (ethyl esters) | Experimental | Fish oil (4 grams/day of combined EPA and DHA) as ethyl esters formulation (0% triglycerides), taken in two divided doses with main meals. Receives: Dietary Supplement: Fish oil (ethyl esters) |
| Soy oil | Placebo comparator | Soy oil supplement with identical total fat content, taken in two divided doses with main meals. Receives: Dietary Supplement: Soy oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Triglycerides at 3 months
Change was calculated as the value at 3 months minus the value at baseline
Measured: Baseline and 3 months
Secondary outcomes (2)
Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months
Change was calculated as the value at 3 months minus the value at baseline
Measured: Baseline and 3 months
Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months
Change was calculated as the number (and percent) of participants who improved their LDL phenotype pattern at 3 months.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Naturals
- Responsible party
- Principal investigator, Christopher Gardner, Stanford University
- Investigators
- Christopher D Gardner, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804427
- Sponsor's protocol ID
- SU-12042008-1358
- Status last verified
- Feb 2023
- First submitted
- 4 Dec 2008
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oelrich B, Dewell A, Gardner CD. Effect of fish oil supplementation on serum triglycerides, LDL cholesterol and LDL subfractions in hypertriglyceridemic adults. Nutr Metab Cardiovasc Dis. 2013 Apr;23(4):350-7. doi: 10.1016/j.numecd.2011.06.003. Epub 2011 Sep 15.
PubMed 21924882
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults
- ClinicalTrials.gov ID
- NCT00804427
- Acronym / sponsor ID
- SU-12042008-1358
- Conditions
- Hypertriglyceridemia
- Keywords
- Fish oil, Triglycerides, Low-density Lipoprotein (LDL) cholesterol, Low-density Lipoprotein (LDL) subclass, Low-density Lipoprotein (LDL) particle size, Low-density Lipoprotein (LDL) phenotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Nordic Naturals
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of two types of omega-3 fats from fish oil on plasma triglycerides. The two types of fish oil are composed of (1) omega-3 fatty acids in triglyceride form; and (2) as esterified free fatty acids (i.e. ethyl esters). Although these two types of fish oil supplements are available to the public, it remains unclear whether they are equally effective in lowering plasma triglycerides.
Detailed description
This study is a double-blinded, parallel design, placebo controlled trial with three active treatment arms to compare the triglyceride (TG) lowering effects of the same dose of EPA and DHA provided in three formulations of supplements that differ in the proportion of omega-3 FA present as ethyl esters vs. triglycerides. The active therapy for each of the three fish oil supplementation arms is 4 g/day of combined EPA and DHA provided as: a) 90% TG formulation, b) 60% TG formulation, or c) ethyl esters (esterified fatty acids)(i.e., 0% TG). The placebo was a soy oil supplement with an identical total fat content. The primary outcome is the 12-week change in TG concentrations in the active groups vs. placebo. Secondary outcomes include LDL particle distribution, defined as either subclasses LDL1, LDL2, LDL3 and LDL4, and LDL subclass phenotype patterns A, B, or A/B.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fish oil (90% triglycerides) | Experimental | Dietary Supplement: Fish oil (90% triglycerides)Fish oil (4 grams/day of combined EPA and DHA) as 90% triglyceride formulation, taken in two divided doses with main meals. |
| Fish oil (60% triglycerides) | Experimental | Dietary Supplement: Fish oil (60% triglycerides)Fish oil (4 grams/day of combined EPA and DHA) as 60% triglyceride formulation, taken in two divided doses with main meals. |
| Fish oil (ethyl esters) | Experimental | Dietary Supplement: Fish oil (ethyl esters)Fish oil (4 grams/day of combined EPA and DHA) as ethyl esters formulation (0% triglycerides), taken in two divided doses with main meals. |
| Soy oil | Placebo comparator | Dietary Supplement: Soy oilSoy oil supplement with identical total fat content, taken in two divided doses with main meals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age: > or = 18 years
- Ethnicity and race: All ethnic and racial backgrounds welcome
- Fasting blood triglycerides greater than or equal to 150 mg/dL
- Planning to be available for clinic visits for the 12 weeks of study participation
- Ability and willingness to give written informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Fish oil (90% triglycerides) | Dietary supplement | Fish oil (90% triglycerides) |
| Fish oil (60% triglycerides) | Dietary supplement | Fish oil (60% triglycerides) |
| Fish oil (ethyl esters) | Dietary supplement | Fish oil (ethyl esters) |
| Soy oil | Dietary supplement | Soy oil |
Primary outcome
Change from baseline in Triglycerides at 3 months
Time frame: Baseline and 3 months
Change was calculated as the value at 3 months minus the value at baseline
2 secondary outcomes
Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months
Time frame: Baseline and 3 months
Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Results publication: PubMed 21924882Oelrich B, Dewell A, Gardner CD. Effect of fish oil supplementation on serum triglycerides, LDL cholesterol and LDL subfractions in hypertriglyceridemic adults. Nutr Metab Cardiovasc Dis. 2013 Apr;23(4):350-7. doi: 10.1016/j.numecd.2011.06.003. Epub 2011 Sep 15.
- Description of study and summary of resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Christopher D Gardner principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil (90% triglycerides), Fish oil (60% triglycerides) and Fish oil (ethyl esters) in people with Hypertriglyceridemia, run by Stanford University 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 17 inclusion and 0 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 22 Feb 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in Triglycerides at 3 months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804427, which also lists 1 linked publication.
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 22 Feb 2023.