Effects of Fatty and Lean Fish Intake on Cardiovascular R... | NCT00720655

Studies
Effects of Fatty and Lean Fish Intake on Cardiovascular Risk Factors in Subjects With Coronary Heart Disease

NCT00720655

Sponsor

University of Eastern Finland

Status

Completed

Last Update Posted

Jan 22, 2014Estimated

Enrollment

33Actual

Phase

Not Applicable

Conditions

Blood Pressure
Arrhythmia
Inflammation

Interventions

Dietary intervention
Dietary intervention
Dietary intervention

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Dec 2006Actual

Completion Date

Not provided

First Submitted Date

Jul 21, 2008

First Submission Date that Met QC Criteria

Jul 22, 2008

First Posted Date

Jul 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2014

Last Update Posted Date

Jan 22, 2014Estimated

Name	Class
Kuopio University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to examine the effects of fatty fish and white (lean) fish on cardiovascular disease risk factor levels in subjects with established coronary heart disease using multiple medications. The main end points are blood pressure, serum lipids, inflammatory markers, arrhythmias and gene expression in peripheral mononuclear cells. The study design was a controlled, parallel study lasting 8 weeks with three diet groups: fatty fish, white fish and control group (lean pork, beef or chicken).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Fatty fish	Experimental	Other: Dietary intervention
Lean Fish	Experimental	Other: Dietary intervention
Control diet	Placebo Comparator	Other: Dietary intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary intervention	Other	Fatty fish at least 4 meals per week.	Fatty fish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure		8 week

Secondary Outcomes

Measure	Description	Time Frame
inflammatory markers		8 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

myocardial infarction or unstable ischemic attack
use of beta blockers
normal sinus rhythm
fasting serum triglyceride less or equal to 3.5 mmol/l
fasting serum cholesterol less or equal to 8 mmol/l
BMI 18.5-30 kg/m2
fasting plasma glucose less or equal to 7 mmol/l

Exclusion Criteria:

diabetes
use of other antiarrhythmic medications than beta blockers
atrial fibrillation
use of psychotropic medications
abnormal liver, thyroid or kidney function
inflammatory bowel disease
excessive use of alcohol
use of fish oil supplements or high habitual intake of fish

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Kuopio		Kuopio		70211	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18665413	Result	Erkkila AT, Schwab US, de Mello VD, Lappalainen T, Mussalo H, Lehto S, Kemi V, Lamberg-Allardt C, Uusitupa MI. Effects of fatty and lean fish intake on blood pressure in subjects with coronary heart disease using multiple medications. Eur J Nutr. 2008 Sep;47(6):319-28. doi: 10.1007/s00394-008-0728-5. Epub 2008 Jul 29.
19669729	Derived

ID	Term
D001145	Arrhythmias, Cardiac
D007249	Inflammation
D003327	Coronary Disease

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics