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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720655
• Other study ID #: FISH6417
• Status: Completed
• Phase: N/A
• First received: July 21, 2008
• Last updated: January 21, 2014
• Start date: August 2005

Study information

• Verified date: January 2014
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia
• Blood Pressure
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Inflammation
• Myocardial Ischemia

Intervention

Other:
• Dietary intervention
Fatty fish at least 4 meals per week.
• Dietary intervention
Lean fish at least 4 meals per week.
• Dietary intervention
Control diet with lean meat and chicken.

Locations

Country	Name	City	State
Finland	University of Kuopio	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
University of Eastern Finland	Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Erkkilä 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure		8 week	No
Secondary	inflammatory markers		8 week	No