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

This study has been completed.
Sponsor:
Collaborators:
Biodroga Inc.
University of Guelph
Information provided by (Responsible Party):
Nutrasource Diagnostics Inc.
ClinicalTrials.gov Identifier:
NCT01690312
First received: September 10, 2012
Last updated: February 6, 2014
Last verified: February 2014
  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:


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
Study Completion Date: February 2014
Primary Completion Date: December 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Nutrasource Diagnostics Inc.
Guelph, Ontario, Canada, N1G 0B4
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: February 6, 2014
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 July 26, 2014