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
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 April 17, 2014