Cardiovascular DiseaseNCT01690312
Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy
A study testing Fish Oil in people with Cardiovascular Disease, run by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. at 1 site in Canada.
Trial summary
The objective of this study is to determine the acute and chronic [4-week] effects of a high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of cardiovascular disease risk, in adults on Statin therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Feb 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be an adult between the ages of 18 and 70;
- Be a male or a post-menopausal female who has gone a minimum of one year since their last menses;
- Be taking Statin medication at a stable dose for a minimum of four weeks prior to study commencement [and whom have reached a target LDL level];
- Have elevated fasting triglyceride levels [greater than 1.5 mmol/L but less than 5.7 mmol/L];
- Have fasting blood glucose levels below the study cut-off [less than 7.0 mmol/L];
- Have a Body Mass Index (BMI) less than 35.0
- Be taking natural health products BUT agree to cease consumption during the study period and a 4-week pre-study washout prior to study commencement. Study participants will be allowed to consume a daily multivitamin if they have been doing so at a stable dose for a minimum of three months prior to study commencement.
Who cannot join
- Be younger than 18 years of age or older than 70 years of age;
- Be an adult pre- or peri-menopausal female;
- Not have taken Statin medication at a stable dose for a minimum of 4 weeks prior to study commencement;
- Have fasting triglyceride levels outside of study limits[ie/ less than 1.5 mmol/L or greater than 5.7 mmol/L];
- Have elevated fasting blood glucose levels [greater or equal to 7.0 mmol/L];
- Have high blood pressure [greater than 140/100]
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- Have a Body Mass Index (BMI) equal to or greater than 35.0
- Have a pre-existing cardiovascular disease or illness, including angina, myocardial infarction, stroke, intermittent claudication or transient ischemic attack;
- Have a known allergy to fish and/or fish oil, olive oil, soy or Vitamin E;
- Be taking natural health products but are unwilling to cease consumption during the study period and a 4-week pre-study washout prior to study commencement;
- Consume more than two (2) fish meals on a weekly basis
- Consume excessive amounts of alcohol on a weekly basis [more than 10 alcoholic drinks per week];
- Anticipate or have planned surgery during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Assess the Acute and Chronic Effects of a High-DHA Fish Oil on Fasting and Post-Prandial Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy.
The objective of this study is to determine the acute and chronic [4-week] effects of a high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of cardiovascular disease risk, in adults on Statin therapy.
Read the detailed description
This study involves fasted and post-prandial components.
Fasted Study:
Participants will provide fasting blood samples pre-and post-intervention [4-week administration of supplement or placebo] in Treatment Period I. Participants will again provide fasting blood samples pre-and post-intervention [4-week administration of supplement or placebo, opposite to Treatment Period I] during Treatment Period II.
There will be a 4-week washout period during the two Treatment Periods.
Post-prandial study:
Participants will also complete a post-prandial study pre-and post-intervention during each Treatment Period.
- Conditions
- Cardiovascular Disease
- Being tested
- Fish Oil, Placebo
- Keywords
- Humans, Cardiovascular Disease, Statins, Fish Oil, DHA, EPA, High-DHA, Triglycerides, Total cholesterol [TC], Lipoproteins, High-density lipoprotein [HDL2, HDL3], Low-density lipoprotein [LDL1+2+3+4], Lipoprotein A [Lp(a)], Intermediate-density lipoprotein (IDL), Very low-density lipoprotein (VLDL1+2, VLDL3), Remnant Lipoproteins, High-sensitivity C-Reactive Protein [hs-CRP], Homocysteine, Essential Fatty Acid Profile, Apolipoprotein B
- Medical subject headings
- Cardiovascular Diseases, Huntington Disease-Like 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of fish oil [620 mg of DHA and 150 mg of EPA], providing a total daily dosage of 4000 mg of fish oil [3080 mg of DHA+EPA].
PlaceboDietary supplement
On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of olive oil, providing a total daily dosage of 4000 mg of olive oil.
| Study group | Role | What they receive |
|---|---|---|
| 1 (Dietary Supplement - Fish Oil) | Experimental | On Day 1 \& Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed.
On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol. Receives: Dietary Supplement: Fish Oil |
| 2 (Placebo) | Experimental | On Day 1 \& Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed.
On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride [TG]
Fasted and postprandial samples will be drawn (hourly up to 6 hours).
Measured: 0 and 4 weeks
Secondary outcomes (14)
Glucose
Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
Measured: 0 and 4 weeks
Insulin
Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
Measured: 0 and 4 weeks
Total cholesterol [TC]
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
High-density lipoprotein [HDL]
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
Low-density lipoprotein [LDL]
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
Very low-density lipoprotein [VLDL]
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
Lipoprotein A
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
Intermediate-density lipoprotein [IDL]
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
Remnant Lipoproteins
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
High-sensitivity C-Reactive Protein [hs-CRP]
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
Homocysteine
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
Essential Fatty Acid Profile
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
Apolipoprotein B
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
Apolipoprotein A-1
A fasted blood sample will be taken.
Measured: 0 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Sponsor type
- Research network
- Collaborators
- Biodroga Inc., University of Guelph
- Responsible party
- Sponsor
- Investigators
- Alison Duncan, Ph.D., R.D., Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690312
- Sponsor's protocol ID
- 11-09-002
- Other IDs
- 150038
- Status last verified
- Feb 2014
- First submitted
- 10 Sep 2012
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Acute and Chronic Effects of a High-DHA Fish Oil on Fasting and Post-Prandial Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy.
- ClinicalTrials.gov ID
- NCT01690312
- Acronym / sponsor ID
- 11-09-002
- Conditions
- Cardiovascular Disease
- Keywords
- Humans, Cardiovascular Disease, Statins, Fish Oil, DHA, EPA, High-DHA, Triglycerides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.Research network
- Collaborators
- Biodroga Inc., University of Guelph
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Sep 2012 (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 objective of this study is to determine the acute and chronic [4-week] effects of a high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of cardiovascular disease risk, in adults on Statin therapy.
Detailed description
This study involves fasted and post-prandial components.
Fasted Study:
Participants will provide fasting blood samples pre-and post-intervention [4-week administration of supplement or placebo] in Treatment Period I. Participants will again provide fasting blood samples pre-and post-intervention [4-week administration of supplement or placebo, opposite to Treatment Period I] during Treatment Period II.
There will be a 4-week washout period during the two Treatment Periods.
Post-prandial study:
Participants will also complete a post-prandial study pre-and post-intervention during each Treatment Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 (Dietary Supplement - Fish Oil) | Experimental | Dietary Supplement: Fish OilOn Day 1 \& Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed. On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol. |
| 2 (Placebo) | Experimental | Dietary Supplement: PlaceboOn Day 1 \& Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed. On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be an adult between the ages of 18 and 70;
- Be a male or a post-menopausal female who has gone a minimum of one year since their last menses;
- Be taking Statin medication at a stable dose for a minimum of four weeks prior to study commencement [and whom have reached a target LDL level];
- Have elevated fasting triglyceride levels [greater than 1.5 mmol/L but less than 5.7 mmol/L];
- Have fasting blood glucose levels below the study cut-off [less than 7.0 mmol/L];
Key exclusion criteria (13 listed)
- Be younger than 18 years of age or older than 70 years of age;
- Be an adult pre- or peri-menopausal female;
- Not have taken Statin medication at a stable dose for a minimum of 4 weeks prior to study commencement;
- Have fasting triglyceride levels outside of study limits[ie/ less than 1.5 mmol/L or greater than 5.7 mmol/L];
- Have elevated fasting blood glucose levels [greater or equal to 7.0 mmol/L];
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 OilOn Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of fish oil [620 mg of DHA and 150 mg of EPA], providing a total daily dosage of 4000 mg of fish oil [3080 mg of DHA+EPA]. | Dietary supplement | 1 (Dietary Supplement - Fish Oil) |
| PlaceboOn Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of olive oil, providing a total daily dosage of 4000 mg of olive oil. | Dietary supplement | 2 (Placebo) |
Primary outcome
Triglyceride [TG]
Time frame: 0 and 4 weeks
Fasted and postprandial samples will be drawn (hourly up to 6 hours).
14 secondary outcomes
Glucose
Time frame: 0 and 4 weeks
Insulin
Time frame: 0 and 4 weeks
Total cholesterol [TC]
Time frame: 0 and 4 weeks
High-density lipoprotein [HDL]
Time frame: 0 and 4 weeks
Low-density lipoprotein [LDL]
Time frame: 0 and 4 weeks
Very low-density lipoprotein [VLDL]
Time frame: 0 and 4 weeks
Lipoprotein A
Time frame: 0 and 4 weeks
Intermediate-density lipoprotein [IDL]
Time frame: 0 and 4 weeks
Remnant Lipoproteins
Time frame: 0 and 4 weeks
High-sensitivity C-Reactive Protein [hs-CRP]
Time frame: 0 and 4 weeks
Homocysteine
Time frame: 0 and 4 weeks
Essential Fatty Acid Profile
Time frame: 0 and 4 weeks
Apolipoprotein B
Time frame: 0 and 4 weeks
Apolipoprotein A-1
Time frame: 0 and 4 weeks
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 7 Feb 2014.
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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.
Alison Duncan, Ph.D., R.D. principal investigator
University of Guelph
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 in people with Cardiovascular Disease, run by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. at 1 site in Canada.
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 7 inclusion and 13 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 7 Feb 2014. 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 Canada. 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.
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?
Triglyceride [TG] (time frame: 0 and 4 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 7 Feb 2014.