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Postprandial Differences After Herring and Beef

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ClinicalTrials.gov Identifier: NCT02381613
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
Oy Foodfiles Ltd
Information provided by (Responsible Party):
Chalmers University of Technology

Tracking Information
First Submitted Date  ICMJE March 5, 2015
First Posted Date  ICMJE March 6, 2015
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
Omega-3 fatty acids [ Time Frame: Area under the curve between 0 and 7 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postprandial Differences After Herring and Beef
Official Title  ICMJE Postprandial Plasma Nutrient Differences Between Baked Beef, Baked Herring and Pickled Herring.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE
  • Other: Baked beef
    A meal based on baked beef
  • Other: Baked herring
    A meal based on baked herring
  • Other: Pickled herring
    A meal based on pickled herring
Study Arms  ICMJE
  • Active Comparator: Baked beef
    A meal based on baked beef
    Intervention: Other: Baked beef
  • Experimental: Baked herring
    A meal based on baked herring
    Intervention: Other: Baked herring
  • Experimental: Pickled herring
    A meal based on pickled herring
    Intervention: Other: Pickled herring
Publications * Ross AB, Svelander C, Undeland I, Pinto R, Sandberg AS. Herring and Beef Meals Lead to Differences in Plasma 2-Aminoadipic Acid, β-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2015)
17
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 67 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02381613
Other Study ID Numbers  ICMJE CSP U-12-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chalmers University of Technology
Study Sponsor  ICMJE Chalmers University of Technology
Collaborators  ICMJE Oy Foodfiles Ltd
Investigators  ICMJE Not Provided
PRS Account Chalmers University of Technology
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP