Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy - Full Text View

Purpose

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.

Condition	Intervention
Cardiovascular Disease	Dietary Supplement: Fish Oil Dietary Supplement: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Diabetes Medicines Dietary Supplements Statins

Drug Information available for: Fish oil

U.S. FDA Resources

Further study details as provided by Nutrasource Diagnostics Inc.:

Primary Outcome Measures:

Triglyceride [TG] [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
Fasted and postprandial samples will be drawn (hourly up to 6 hours).

Secondary Outcome Measures:

Glucose [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
Insulin [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
Total cholesterol [TC] [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
High-density lipoprotein [HDL] [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
Low-density lipoprotein [LDL] [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
Very low-density lipoprotein [VLDL] [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
Lipoprotein A [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
Intermediate-density lipoprotein [IDL] [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
Remnant Lipoproteins [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
High-sensitivity C-Reactive Protein [hs-CRP] [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
Homocysteine [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
Essential Fatty Acid Profile [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
Apolipoprotein B [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.
Apolipoprotein A-1 [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
A fasted blood sample will be taken.

Estimated Enrollment:	36
Study Start Date:	September 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 (Dietary Supplement - Fish Oil) 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.	Dietary Supplement: Fish Oil 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].
Experimental: 2 (Placebo) 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.	Dietary Supplement: Placebo 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.

Arms

Assigned Interventions

Experimental: 1 (Dietary Supplement - Fish Oil)

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.

Dietary Supplement: Fish Oil

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].

Experimental: 2 (Placebo)

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.

Dietary Supplement: Placebo

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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]
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690312

Contacts

Contact: Krista Coventry, M.Sc.	519 341-3363	kcoventry@nutrasource.ca
Contact: Carla Cockerline, M.Sc.	519 341-3362	ccockerline@nutrasource.ca

Locations

Canada, Ontario
Nutrasource Diagnostics Inc.	Recruiting
Guelph, Ontario, Canada, N1G 0B4
Contact: Krista Coventry, M.Sc. 519 341-3363 kcoventry@nutrasource.ca
Contact: Carla Cockerline, M.Sc. 519 341-3362 ccockerline@nutrasource.ca
Principal Investigator: Alison Duncan, Ph.D, R.D.
Sub-Investigator: Krista Coventry, M.Sc.

Sponsors and Collaborators

Nutrasource Diagnostics Inc.

Biodroga Inc.

University of Guelph

Investigators

Principal Investigator:

Alison Duncan, Ph.D., R.D.

University of Guelph

More Information

No publications provided

Responsible Party:	Nutrasource Diagnostics Inc.
ClinicalTrials.gov Identifier:	NCT01690312 History of Changes
Other Study ID Numbers:	11-09-002, 150038
Study First Received:	September 10, 2012
Last Updated:	September 18, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Nutrasource Diagnostics Inc.:

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
Apolipoprotein A-1
Glucose
Insulin
Fasted
Post-Prandial

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013