Cardiovascular DiseaseNCT02381613
Postprandial Differences After Herring and Beef
A study testing Baked beef, Baked herring and Pickled herring in people with Cardiovascular Disease, run by Chalmers University of Technology.
Trial summary
While observational studies often find that diets rich in fish reduce the risk of disease, and that diets including a high intake of red meat are associated with increased risk of cardiovascular disease and cancer, the difference in health effects between red meat and fish are rarely researched in intervention… Read more about this study
- Who is it for?
- Ages 35 to 67 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Baked beef, Baked herring and Pickled herring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2015
- 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 35 to 67 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- 35-67 years
- BMI >30 kg/m2
- Normally eats lunch and dinner
Who cannot join
- Smoke or oral tobacco use
- Use of prescription or recreational drugs likely to interfere with primary outcome
- Change in body weight in the month prior to the study
- Abnormal blood biomarker values (assessed by a clinician)
About this study
Official title: Postprandial Plasma Nutrient Differences Between Baked Beef, Baked Herring and Pickled Herring.
While observational studies often find that diets rich in fish reduce the risk of disease, and that diets including a high intake of red meat are associated with increased risk of cardiovascular disease and cancer, the difference in health effects between red meat and fish are rarely researched in intervention studies.
The investigators hypothesise that the post-prandial plasma response of lipids and markers of cardiovascular disease risk will be more favourable after intake of herring compared to beef.
In addition, while pickling herring in a brine/sugar solution is a common form of preparation, little is known if there is a difference in potential health effects based on the preparation of herring. The investigators will compare baked and pickled herring to understand if preparation is potentially an important factor to be considered when looking at intake of fish and health.
- Conditions
- Cardiovascular Disease
- Being tested
- Baked beef, Baked herring, Pickled herring
- Keywords
- Fish, Herring, Meat, Beef
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baked beefOther
A meal based on baked beef
Baked herringOther
A meal based on baked herring
Pickled herringOther
A meal based on pickled herring
| Study group | Role | What they receive |
|---|---|---|
| Baked beef | Active comparator | A meal based on baked beef Receives: Other: Baked beef |
| Baked herring | Experimental | A meal based on baked herring Receives: Other: Baked herring |
| Pickled herring | Experimental | A meal based on pickled herring Receives: Other: Pickled herring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega-3 fatty acids
Measured: Area under the curve between 0 and 7 hours
Secondary outcomes (6)
Plasms insulin
Measured: Area under the curve between 0 and 7 hours
Plasma triglycerides
Measured: Area under the curve between 0 and 7 hours
Plasma lipoprotein-cholesterol
Measured: Area under the curve between 0 and 7 hours
Plasma vitamin D
Measured: Area under the curve between 0 and 7 hours
Plasma metabolomic profile
Measured: Area under the curve between 0 and 7 hours
Urinary metabolomics
Measured: Area under the curve between 0 and 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionMar 2015
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 DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Oy Foodfiles Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381613
- Sponsor's protocol ID
- CSP U-12-001
- Status last verified
- Mar 2015
- First submitted
- 5 Mar 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ross AB, Svelander C, Undeland I, Pinto R, Sandberg AS. Herring and Beef Meals Lead to Differences in Plasma 2-Aminoadipic Acid, beta-Alanine, 4-Hydroxyproline, Cetoleic Acid, and Docosahexaenoic Acid Concentrations in Overweight Men. J Nutr. 2015 Nov;145(11):2456-63. doi: 10.3945/jn.115.214262. Epub 2015 Sep 23.
PubMed 26400963
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Plasma Nutrient Differences Between Baked Beef, Baked Herring and Pickled Herring.
- ClinicalTrials.gov ID
- NCT02381613
- Acronym / sponsor ID
- CSP U-12-001
- Conditions
- Cardiovascular Disease
- Keywords
- Fish, Herring, Meat, Beef
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Oy Foodfiles Ltd
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Mar 2015 (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.
While observational studies often find that diets rich in fish reduce the risk of disease, and that diets including a high intake of red meat are associated with increased risk of cardiovascular disease and cancer, the difference in health effects between red meat and fish are rarely researched in intervention studies.
The investigators hypothesise that the post-prandial plasma response of lipids and markers of cardiovascular disease risk will be more favourable after intake of herring compared to beef.
In addition, while pickling herring in a brine/sugar solution is a common form of preparation, little is known if there is a difference in potential health effects based on the preparation of herring. The investigators will compare baked and pickled herring to understand if preparation is potentially an important factor to be considered when looking at intake of fish and health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baked beef | Active comparator | Other: Baked beefA meal based on baked beef |
| Baked herring | Experimental | Other: Baked herringA meal based on baked herring |
| Pickled herring | Experimental | Other: Pickled herringA meal based on pickled herring |
Who may qualify
- Ages
- 35 to 67 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- 35-67 years
- BMI >30 kg/m2
- Normally eats lunch and dinner
Key exclusion criteria (4 listed)
- Smoke or oral tobacco use
- Use of prescription or recreational drugs likely to interfere with primary outcome
- Change in body weight in the month prior to the study
- Abnormal blood biomarker values (assessed by a clinician)
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 |
|---|---|---|
| Baked beefA meal based on baked beef | Other | Baked beef |
| Baked herringA meal based on baked herring | Other | Baked herring |
| Pickled herringA meal based on pickled herring | Other | Pickled herring |
Primary outcome
Omega-3 fatty acids
Time frame: Area under the curve between 0 and 7 hours
6 secondary outcomes
Plasms insulin
Time frame: Area under the curve between 0 and 7 hours
Plasma triglycerides
Time frame: Area under the curve between 0 and 7 hours
Plasma lipoprotein-cholesterol
Time frame: Area under the curve between 0 and 7 hours
Plasma vitamin D
Time frame: Area under the curve between 0 and 7 hours
Plasma metabolomic profile
Time frame: Area under the curve between 0 and 7 hours
Urinary metabolomics
Time frame: Area under the curve between 0 and 7 hours
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 6 Mar 2015.
- Derived from this study: PubMed 26400963Ross AB, Svelander C, Undeland I, Pinto R, Sandberg AS. Herring and Beef Meals Lead to Differences in Plasma 2-Aminoadipic Acid, beta-Alanine, 4-Hydroxyproline, Cetoleic Acid, and Docosahexaenoic Acid Concentrations in Overweight Men. J Nutr. 2015 Nov;145(11):2456-63. doi: 10.3945/jn.115.214262. Epub 2015 Sep 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.
Questions about this trial
What is this clinical trial studying?
A study testing Baked beef, Baked herring and Pickled herring in people with Cardiovascular Disease, run by Chalmers University of Technology.
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 4 inclusion and 4 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Omega-3 fatty acids (time frame: Area under the curve between 0 and 7 hours). 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 NCT02381613, 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 6 Mar 2015.