- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02381613
Postprandial Differences After Herring and Beef
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male
- 35-67 years
- BMI >30 kg/m2
- Normally eats lunch and dinner
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Baked beef
A meal based on baked beef
|
A meal based on baked beef
|
Experimental: Baked herring
A meal based on baked herring
|
A meal based on baked herring
|
Experimental: Pickled herring
A meal based on pickled herring
|
A meal based on pickled herring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Omega-3 fatty acids
Time Frame: Area under the curve between 0 and 7 hours
|
Area under the curve between 0 and 7 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasms insulin
Time Frame: Area under the curve between 0 and 7 hours
|
Area under the curve between 0 and 7 hours
|
Plasma triglycerides
Time Frame: Area under the curve between 0 and 7 hours
|
Area under the curve between 0 and 7 hours
|
Plasma lipoprotein-cholesterol
Time Frame: Area under the curve between 0 and 7 hours
|
Area under the curve between 0 and 7 hours
|
Plasma vitamin D
Time Frame: Area under the curve between 0 and 7 hours
|
Area under the curve between 0 and 7 hours
|
Plasma metabolomic profile
Time Frame: Area under the curve between 0 and 7 hours
|
Area under the curve between 0 and 7 hours
|
Urinary metabolomics
Time Frame: Area under the curve between 0 and 7 hours
|
Area under the curve between 0 and 7 hours
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSP U-12-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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