NCT00720655

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2008

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

July 21, 2008

Last Update Submit

January 21, 2014

Conditions

Blood PressureArrhythmiaInflammation

Keywords

coronary heart disease

Outcome Measures

Primary Outcomes (1)

  • gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure

    8 week

Secondary Outcomes (1)

  • inflammatory markers

    8 week

Study Arms (3)

Fatty fish

EXPERIMENTAL
Other: Dietary intervention

Lean Fish

EXPERIMENTAL
Other: Dietary intervention

Control diet

PLACEBO COMPARATOR
Other: Dietary intervention

Interventions

Dietary interventionOTHER

Fatty fish at least 4 meals per week.

Fatty fish

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kuopio

Kuopio, 70211, Finland

Location

Related Publications (3)

  • 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.

    PMID: 18665413RESULT

  • 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.

    PMID: 19669729DERIVED

  • 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.

    PMID: 19390588DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacInflammationCoronary Disease

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaVascular Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 23, 2008

Study Start

August 1, 2005

Primary Completion

December 1, 2006

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

FI(1)