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MEPO: Biomarkers of Meats and Potatoes Intake

Sponsor
Professor Lars Ove Dragsted (Other)
Overall Status
Completed
CT.gov ID
NCT04548362
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
3.4
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Meat arm
  • Other: Starchy foods arm
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Subjects were randomised to four meals with meats and starchy foods in such a way that all volunteers had each meat and each starchy food once and so that all combinations of meats and starchy foods were equally common. Each volunteer was also randomised to the sequence of the meals.Subjects were randomised to four meals with meats and starchy foods in such a way that all volunteers had each meat and each starchy food once and so that all combinations of meats and starchy foods were equally common. Each volunteer was also randomised to the sequence of the meals.
Masking:
None (Open Label)
Masking Description:
It is not possible to mask foods and for the explorative analysis of results, masking is not required.
Primary Purpose:
Basic Science
Official Title:
Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study
Actual Study Start Date :
Feb 15, 2016
Actual Primary Completion Date :
May 30, 2016
Actual Study Completion Date :
May 30, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. meat intake biomarkers [0-48 hours]

    To identify intake biomarkers of general meat, red meat and poultry

  2. Potato intake biomarkers [0-48 hours]

    To identify intake biomarkers of general potato, fried potato and white rice

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • healthy
Exclusion Criteria:
  • non-pregnant, no abuse of alcohol or drugs, no chronic medication except p-pills

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lars Dragsted Frederiksberg Denmark 1958

Sponsors and Collaborators

  • Professor Lars Ove Dragsted

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Professor Lars Ove Dragsted, Professor, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT04548362
Other Study ID Numbers:
  • H-150204011H
First Posted:
Sep 14, 2020
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Professor Lars Ove Dragsted, Professor, University of Copenhagen
Biomarkers of food intake
Additional relevant MeSH terms:
Nutrition Disorders

Study Results

No Results Posted as of Apr 28, 2021