NCT02381613

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 5, 2015

Last Update Submit

March 5, 2015

Conditions

Keywords

FishHerringMeatBeef

Outcome Measures

Primary Outcomes (1)

  • Omega-3 fatty acids

    Area under the curve between 0 and 7 hours

Secondary Outcomes (6)

  • Plasms insulin

    Area under the curve between 0 and 7 hours

  • Plasma triglycerides

    Area under the curve between 0 and 7 hours

  • Plasma lipoprotein-cholesterol

    Area under the curve between 0 and 7 hours

  • Plasma vitamin D

    Area under the curve between 0 and 7 hours

  • Plasma metabolomic profile

    Area under the curve between 0 and 7 hours

  • +1 more secondary outcomes

Study Arms (3)

Baked beef

ACTIVE COMPARATOR

A meal based on baked beef

Other: Baked beef

Baked herring

EXPERIMENTAL

A meal based on baked herring

Other: Baked herring

Pickled herring

EXPERIMENTAL

A meal based on pickled herring

Other: Pickled herring

Interventions

A meal based on baked beef

Baked beef

A meal based on baked herring

Baked herring

A meal based on pickled herring

Pickled herring

Eligibility Criteria

Age35 Years - 67 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • years
  • BMI \>30 kg/m2
  • Normally eats lunch and dinner

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 6, 2015

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

March 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03