Back to results

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

Primary Purpose

Blood Pressure, Arrhythmia, Inflammation

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Dietary intervention

About this trial

This is an interventional treatment trial for Blood Pressure focused on measuring coronary heart disease

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kuopio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Fatty fish

Lean Fish

Control diet

Arm Description

Outcomes

Primary Outcome Measures

gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure

Secondary Outcome Measures

inflammatory markers

Full Information

NCT ID

NCT00720655

First Posted

July 21, 2008

Last Updated

January 21, 2014

Sponsor

University of Eastern Finland

Collaborators

Kuopio University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00720655

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Eastern Finland

Collaborators

Kuopio University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Pressure, Arrhythmia, Inflammation

Keywords

coronary heart disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fatty fish

Arm Type

Experimental

Arm Title

Lean Fish

Arm Type

Experimental

Arm Title

Control diet

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Dietary intervention

Intervention Description

Fatty fish at least 4 meals per week.

Intervention Type

Other

Intervention Name(s)

Dietary intervention

Intervention Description

Lean fish at least 4 meals per week.

Intervention Type

Other

Intervention Name(s)

Dietary intervention

Intervention Description

Control diet with lean meat and chicken.

Primary Outcome Measure Information:

Title

gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure

Time Frame

8 week

Secondary Outcome Measure Information:

Title

inflammatory markers

Time Frame

8 week

10. Eligibility

Sex

All

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

University of Kuopio

City

Kuopio

ZIP/Postal Code

70211

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

18665413

Citation

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.

Results Reference

result

PubMed Identifier

19669729

Citation

de Mello VD, Lankinen M, Schwab U, Kolehmainen M, Lehto S, Seppanen-Laakso T, Oresic M, Pulkkinen L, Uusitupa M, Erkkila AT. Link between plasma ceramides, inflammation and insulin resistance: association with serum IL-6 concentration in patients with coronary heart disease. Diabetologia. 2009 Dec;52(12):2612-5. doi: 10.1007/s00125-009-1482-9. Epub 2009 Aug 11.

Results Reference

derived

PubMed Identifier

19390588

Citation

Lankinen M, Schwab U, Erkkila A, Seppanen-Laakso T, Hannila ML, Mussalo H, Lehto S, Uusitupa M, Gylling H, Oresic M. Fatty fish intake decreases lipids related to inflammation and insulin signaling--a lipidomics approach. PLoS One. 2009;4(4):e5258. doi: 10.1371/journal.pone.0005258. Epub 2009 Apr 23.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs