Cardiovascular DiseasesNCT00432952
Acute Single Meal Effects of Trout on Cardiovascular Risk Markers and Plasma Proteome
A study of Cardiovascular Diseases and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The acute effects of farmed rainbow trout, fed by various feeds versus a control meal with poultry meat on cardiovascular risk markers and plasma protein expression are investigated. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Metabolic Syndrome
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Jan 2009
- 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 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non regular smokers
- Body Mass Index (18.5-30 kg/m2)
- Able to eat fish
Who cannot join
- Exercise >10 h/week
- Chronical diseases (eg. cardiovascular and diabetes)
- Regular medication
- Fish oil supplementation
- Blood donation 2 month prior or during participation
- Above maximum recommended alcohol intake
- Blood pressure >160/100 mm Hg
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Human Nutrition, University of Copenhagen
Frederiksberg C, 1958
About this study
The acute effects of farmed rainbow trout, fed by various feeds versus a control meal with poultry meat on cardiovascular risk markers and plasma protein expression are investigated.
The hypotheses of the study are that if the feed are changed from a marine origin to primarily a vegetable origin the content of long chain n-3 poly unsaturated fatty acids (n-3 PUFA) will decrease in the meat and thus possibly result in a decreased effect on health. Furthermore, the feed of the trouts are also expected to give rise to differences in the human plasma protein profile and fatty acid composition after consumption, which could be associated with physiological effects.
Read the detailed description
In a controlled, single blinded human single meal study the acute effects of farmed rainbow trout, fed by various feeds versus a control meal with poultry meat on cardiovascular risk markers and plasma protein expression are investigated. 6 healthy men, age 40-70, will be randomized to trout fed on only vegetable, only marine and a mix of different compositions of vegetable and marine feeds. Outcome variables are blood pressure, pulse wave analyse, pulse wave velocity, plasma protein profile, and plasma triglycerides.
The hypotheses of the study are that if the feed are changed from a marine origin to primarily a vegetable origin the content of long chain n-3 poly unsaturated fatty acids (n-3 PUFA) will decrease in the meat and thus possibly result in a decreased effect on health. Furthermore, the feed of the trouts are also expected to give rise to differences in the human plasma protein profile and fatty acid composition after consumption, which could be associated with physiological effects.
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome
- Being tested
- Intake of rainbow trout from different feeding conditions versus a control poultry meal
- Keywords
- Cardiovascular Heart Disease
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intake of rainbow trout from different feeding conditions versus a control poultry mealBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma protein expression
Blood Pressure
Pulse Wave Analysis
Pulse wave Velocity
Secondary outcomes (1)
Plasma Triglycerides
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2007
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 6 participants
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Institute of Fisheries Research
- Investigators
- Lotte Lauritzen, Ph.D, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432952
- Sponsor's protocol ID
- M186
- Status last verified
- Aug 2008
- First submitted
- 7 Feb 2007
- Last updated
- 13 Aug 2008
- Results posted
- No
Publications
Rentsch ML, Lametsch R, Bugel S, Jessen F, Lauritzen L. The effects of eating marine- or vegetable-fed farmed trout on the human plasma proteome profiles of healthy men. Br J Nutr. 2015 Feb 28;113(4):699-707. doi: 10.1017/S0007114514004152. Epub 2015 Jan 27.
PubMed 25622825
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Single Meal Effects of Trout on Cardiovascular Risk Markers and Plasma Proteome
- ClinicalTrials.gov ID
- NCT00432952
- Acronym / sponsor ID
- M186
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome
- Keywords
- Cardiovascular Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Danish Institute of Fisheries Research
- Study start
- Jan 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jan 2009 (estimated)
- First posted
- 8 Feb 2007 (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 acute effects of farmed rainbow trout, fed by various feeds versus a control meal with poultry meat on cardiovascular risk markers and plasma protein expression are investigated.
The hypotheses of the study are that if the feed are changed from a marine origin to primarily a vegetable origin the content of long chain n-3 poly unsaturated fatty acids (n-3 PUFA) will decrease in the meat and thus possibly result in a decreased effect on health. Furthermore, the feed of the trouts are also expected to give rise to differences in the human plasma protein profile and fatty acid composition after consumption, which could be associated with physiological effects.
Detailed description
In a controlled, single blinded human single meal study the acute effects of farmed rainbow trout, fed by various feeds versus a control meal with poultry meat on cardiovascular risk markers and plasma protein expression are investigated. 6 healthy men, age 40-70, will be randomized to trout fed on only vegetable, only marine and a mix of different compositions of vegetable and marine feeds. Outcome variables are blood pressure, pulse wave analyse, pulse wave velocity, plasma protein profile, and plasma triglycerides.
The hypotheses of the study are that if the feed are changed from a marine origin to primarily a vegetable origin the content of long chain n-3 poly unsaturated fatty acids (n-3 PUFA) will decrease in the meat and thus possibly result in a decreased effect on health. Furthermore, the feed of the trouts are also expected to give rise to differences in the human plasma protein profile and fatty acid composition after consumption, which could be associated with physiological effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non regular smokers
- Body Mass Index (18.5-30 kg/m2)
- Able to eat fish
Key exclusion criteria (7 listed)
- Exercise >10 h/week
- Chronical diseases (eg. cardiovascular and diabetes)
- Regular medication
- Fish oil supplementation
- Blood donation 2 month prior or during participation
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 |
|---|---|---|
| Intake of rainbow trout from different feeding conditions versus a control poultry meal | Behavioural | – |
Primary outcome
plasma protein expression
Blood Pressure
Pulse Wave Analysis
Pulse wave Velocity
1 secondary outcome
Plasma Triglycerides
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2008.
- Derived from this study: PubMed 25622825Rentsch ML, Lametsch R, Bugel S, Jessen F, Lauritzen L. The effects of eating marine- or vegetable-fed farmed trout on the human plasma proteome profiles of healthy men. Br J Nutr. 2015 Feb 28;113(4):699-707. doi: 10.1017/S0007114514004152. Epub 2015 Jan 27.
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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.
Lotte Lauritzen, Ph.D principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiovascular Diseases and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Aug 2008. 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 Denmark. 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. 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?
Results are not available in the source record.
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?
plasma protein expression. The study lists 4 primary outcomes in all. 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 NCT00432952, which also lists 1 linked publication.
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 13 Aug 2008.