Blood PressureNCT00720655
Effects of Fatty and Lean Fish Intake on Cardiovascular Risk Factors in Subjects With Coronary Heart Disease
A study testing Dietary intervention in people with Blood Pressure and Arrhythmia, run by University of Eastern Finland at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Blood Pressure, Arrhythmia, Inflammation
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2005to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Blood Pressure, Arrhythmia, Inflammation
- Being tested
- Dietary intervention
- Keywords
- coronary heart disease
- Medical subject headings
- Arrhythmias, Cardiac, Inflammation, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Fatty fish at least 4 meals per week.
Dietary interventionOther
Lean fish at least 4 meals per week.
Dietary interventionOther
Control diet with lean meat and chicken.
| Study group | Role | What they receive |
|---|---|---|
| Fatty fish | Experimental | Not described Receives: Other: Dietary intervention |
| Lean Fish | Experimental | Not described Receives: Other: Dietary intervention |
| Control diet | Placebo comparator | Not described Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure
Measured: 8 week
Secondary outcomes (1)
inflammatory markers
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startAug 2005
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720655
- Sponsor's protocol ID
- FISH6417
- Status last verified
- Jan 2014
- First submitted
- 21 Jul 2008
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18665413de 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.
PubMed 19669729Lankinen 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.
PubMed 19390588
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fatty and Lean Fish Intake on Cardiovascular Risk Factors in Subjects With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00720655
- Acronym / sponsor ID
- FISH6417
- Conditions
- Blood Pressure, Arrhythmia, Inflammation
- Keywords
- coronary heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Kuopio University Hospital
- Study start
- Aug 2005
- Primary completion
- Dec 2006 (actual)
- First posted
- 23 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fatty fish | Experimental | Other: Dietary intervention |
| Lean Fish | Experimental | Other: Dietary intervention |
| Control diet | Placebo comparator | Other: Dietary intervention |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- diabetes
- use of other antiarrhythmic medications than beta blockers
- atrial fibrillation
- use of psychotropic medications
- abnormal liver, thyroid or kidney function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionFatty fish at least 4 meals per week. | Other | Fatty fish |
| Dietary interventionLean fish at least 4 meals per week. | Other | Lean Fish |
| Dietary interventionControl diet with lean meat and chicken. | Other | Control diet |
Primary outcome
gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure
Time frame: 8 week
1 secondary outcome
inflammatory markers
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Results publication: PubMed 18665413Erkkila 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.
- Derived from this study: PubMed 19669729de 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.
- Derived from this study: PubMed 19390588Lankinen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Blood Pressure and Arrhythmia, run by University of Eastern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00720655, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.