Clinical trial NCT00720655: 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
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Arrhythmia
Inflammation
Keywords: coronary heart disease
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Kuopio University Hospital
First posted: 2008-07-23
Enrollment: 33
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure
timeFrame: 8 week
Secondary outcomes:
measure: inflammatory markers
timeFrame: 8 week
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Kuopio
Study officials:
References:
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.
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.
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.