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
Dietary intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Blood Pressure focused on measuring coronary heart disease
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
Sites / Locations
- University of Kuopio
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
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
No
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
No
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
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