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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by University of Eastern Finland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Kuopio University Hospital
Information provided by:
University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT00720655
First received: July 21, 2008
Last updated: January 11, 2013
Last verified: July 2008
History of Changes
  Purpose

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).


Condition Intervention
Blood Pressure
Arrhythmia
Inflammation
 Other: Dietary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Fatty and Lean Fish Intake on Cardiovascular Risk Factors in Subjects With Coronary Heart Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:
  • gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure [ Time Frame: 8 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • inflammatory markers [ Time Frame: 8 week ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2005
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fatty fish Other: Dietary intervention
Fatty fish at least 4 meals per week.
Experimental: Lean Fish Other: Dietary intervention
Lean fish at least 4 meals per week.
Placebo Comparator: Control diet Other: Dietary intervention
Control diet with lean meat and chicken.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720655

Locations
Finland
University of Kuopio
Kuopio, Finland, 70211
Sponsors and Collaborators
University of Eastern Finland
Kuopio University Hospital
  More Information

Publications:
Erkkilä AT, Schwab US, de Mello VDF, Lappalainen T, Mussalo H, Lehto S, Kemi V, Lamberg-Allardt C, Uusitupa MIJ. Effects of fatty and lean fish intake on blood pressure and fatty acid profile of serum lipids in subjects with coronary heart disease. Eur J Nutr (in press)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Arja Erkkilä, University of Kuopio
ClinicalTrials.gov Identifier: NCT00720655     History of Changes
Other Study ID Numbers: FISH6417
Study First Received: July 21, 2008
Last Updated: January 11, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by University of Eastern Finland:
coronary heart disease

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Inflammation
 Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013