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

NCT ID: NCT00720655

Last Updated: 2014-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Blood Pressure Arrhythmia Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fatty fish

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type OTHER

Fatty fish at least 4 meals per week.

Lean Fish

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type OTHER

Lean fish at least 4 meals per week.

Control diet

Group Type PLACEBO_COMPARATOR

Dietary intervention

Intervention Type OTHER

Control diet with lean meat and chicken.

Interventions

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Dietary intervention

Fatty fish at least 4 meals per week.

Intervention Type OTHER

Dietary intervention

Lean fish at least 4 meals per week.

Intervention Type OTHER

Dietary intervention

Control diet with lean meat and chicken.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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University of Kuopio

Locations

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University of Kuopio

Kuopio, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type RESULT
PMID: 18665413 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19669729 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19390588 (View on PubMed)

Other Identifiers

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FISH6417

Identifier Type: -

Identifier Source: org_study_id

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