Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults… (NCT01690312) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy
Canada36 participantsStarted 2012-09
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Triglyceride [TG]
Timeframe: 0 and 4 weeks
Trial details
NCT IDNCT01690312
SponsorNutrasource Pharmaceutical and Nutraceutical Services, Inc.