Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT01690312
Status:
COMPLETED
Last Update Posted:
2014-02-07
First Post:
2012-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy
Sponsor:
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 150038 | OTHER | Health Canada | View |