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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02381613
Other study ID # CSP U-12-001
Secondary ID
Status Completed
Phase N/A
First received March 5, 2015
Last updated March 5, 2015
Start date January 2012
Est. completion date March 2015

Study information

Verified date March 2015
Source Chalmers University of Technology
Contact n/a
Is FDA regulated No
Health authority Sweden: Central Ethical Review Board
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date March 2015
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 35 Years to 67 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Baked beef
A meal based on baked beef
Baked herring
A meal based on baked herring
Pickled herring
A meal based on pickled herring

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Chalmers University of Technology Oy Foodfiles Ltd

Outcome

Type Measure Description Time frame Safety issue
Primary Omega-3 fatty acids Area under the curve between 0 and 7 hours No
Secondary Plasms insulin Area under the curve between 0 and 7 hours No
Secondary Plasma triglycerides Area under the curve between 0 and 7 hours No
Secondary Plasma lipoprotein-cholesterol Area under the curve between 0 and 7 hours No
Secondary Plasma vitamin D Area under the curve between 0 and 7 hours No
Secondary Plasma metabolomic profile Area under the curve between 0 and 7 hours No
Secondary Urinary metabolomics Area under the curve between 0 and 7 hours No
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