Postprandial Differences After Herring and Beef

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

Tracking Information

• First Submitted Date: March 5, 2015
• First Posted Date: March 6, 2015
• Last Update Posted Date: March 6, 2015
• Study Start Date: January 2012
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 5, 2015): Omega-3 fatty acids [ Time Frame: Area under the curve between 0 and 7 hours ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Postprandial Differences After Herring and Beef
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Investigator); Primary Purpose: Basic Science
• Condition: Cardiovascular Disease

Intervention

• 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

• 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, 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 5, 2015): 17
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 35 Years to 67 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02381613
• Other Study ID Numbers: CSP U-12-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Chalmers University of Technology
• Original Responsible Party: Same as current
• Current Study Sponsor: Chalmers University of Technology
• Original Study Sponsor: Same as current
• Collaborators: Oy Foodfiles Ltd
• Investigators: Not Provided
• PRS Account: Chalmers University of Technology
• Verification Date: March 2015