Biomarkers of Meats and Potatoes Intake (MEPO)

April 26, 2021 updated by: Professor Lars Ove Dragsted

Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study

This cross-over meal study is a four-way intervention with 12 volunteers randomized at the same time to four meals with fried meats (beef, pork, chicken and amino-acid matched non-meat control) and to four meals with potato products (boiled, chips, fries, and a control with boiled white rice) to search for biomarkers of intake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a two-dimensional, cross-over meal study, 12 healthy volunteers consumed in a randomized sequence four test meals: chicken, pork, beef, and a control made of egg white and pea. At the same time they were independently randomized to four starchy foods to be consumed together with the meats: boiled potatoes, fried potatoes, potato crisps or boiled white rice. Fasting and postprandial urine samples were collected to cover 48 h after each meal and samples were profiled by untargeted LC-ESI-qTOF-MS metabolomics. The profiles following the meal challenges were explored by univariate and multivariate analyses and single and combined markers of intake identified chemically by MS/MS fragmentation experiments and statistically by ROC curves and error rates as well as FDR statistics.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 1958
        • Lars Dragsted

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • non-pregnant, no abuse of alcohol or drugs, no chronic medication except p-pills

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meat meals
This arm contains a 4-way cross-over intervention study with meats
Other: Meat arm
Randomised sequence of pork, beef, chicken meat, and an egg white/pea combination
Experimental: Starchy meals
This arm contains a 4-way cross-over intervention study with
Other: Starchy foods arm
Randomised sequence of boiled potato, fried potato, potato crisps, and boiled white rice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
meat intake biomarkers
Time Frame: 0-48 hours
To identify intake biomarkers of general meat, red meat and poultry
0-48 hours
Potato intake biomarkers
Time Frame: 0-48 hours
To identify intake biomarkers of general potato, fried potato and white rice
0-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Lars Ove Dragsted

Investigators

  • Study Director: Catalina Cuparencu, PhD, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2016

Primary Completion (Actual)

May 30, 2016

Study Completion (Actual)

May 30, 2016

Study Registration Dates

First Submitted

September 7, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-150204011H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Adding samples to CUBE (www.cube.ku.dk), supporting information to the ERDA sharing system, and sample database and study data to the DASH-IN database for data sharing.

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

after contact with PI; only anonymized information will be provided.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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