NCT01690312

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

September 10, 2012

Last Update Submit

February 6, 2014

Conditions

Cardiovascular Disease

Keywords

HumansCardiovascular DiseaseStatinsFish OilDHAEPAHigh-DHATriglyceridesTotal cholesterol [TC]LipoproteinsHigh-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 LipoproteinsHigh-sensitivity C-Reactive Protein [hs-CRP]HomocysteineEssential Fatty Acid ProfileApolipoprotein BApolipoprotein A-1GlucoseInsulinFastedPost-Prandial

Outcome Measures

Primary Outcomes (1)

  • Triglyceride [TG]

    Fasted and postprandial samples will be drawn (hourly up to 6 hours).

    0 and 4 weeks

Secondary Outcomes (14)

  • Glucose

    0 and 4 weeks

  • Insulin

    0 and 4 weeks

  • Total cholesterol [TC]

    0 and 4 weeks

  • High-density lipoprotein [HDL]

    0 and 4 weeks

  • Low-density lipoprotein [LDL]

    0 and 4 weeks

  • +9 more secondary outcomes

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

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 \[3080 mg of DHA+EPA\].

1 (Dietary Supplement - Fish Oil)
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.

2 (Placebo)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrasource Diagnostics Inc.

Guelph, Ontario, N1G 0B4, Canada

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHuntington Disease-Like 2Insulin Resistance

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Alison Duncan, Ph.D., R.D.

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 21, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

CA(1)