Biomarkers of Meats and Potatoes Intake (MEPO)
Primary Purpose
Nutrition Disorders
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Meat arm
Starchy foods arm
Sponsored by
About this trial
This is an interventional basic science trial for Nutrition Disorders focused on measuring Biomarkers of food intake
Eligibility Criteria
Inclusion Criteria:
- healthy
Exclusion Criteria:
- non-pregnant, no abuse of alcohol or drugs, no chronic medication except p-pills
Sites / Locations
- Lars Dragsted
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Meat meals
Starchy meals
Arm Description
This arm contains a 4-way cross-over intervention study with meats
This arm contains a 4-way cross-over intervention study with
Outcomes
Primary Outcome Measures
meat intake biomarkers
To identify intake biomarkers of general meat, red meat and poultry
Potato intake biomarkers
To identify intake biomarkers of general potato, fried potato and white rice
Secondary Outcome Measures
Full Information
NCT ID
NCT04548362
First Posted
September 7, 2020
Last Updated
April 26, 2021
Sponsor
Professor Lars Ove Dragsted
1. Study Identification
Unique Protocol Identification Number
NCT04548362
Brief Title
Biomarkers of Meats and Potatoes Intake
Acronym
MEPO
Official Title
Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
May 30, 2016 (Actual)
Study Completion Date
May 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Professor Lars Ove Dragsted
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders
Keywords
Biomarkers of food intake
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
None (Open Label)
Masking Description
It is not possible to mask foods and for the explorative analysis of results, masking is not required.
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meat meals
Arm Type
Experimental
Arm Description
This arm contains a 4-way cross-over intervention study with meats
Arm Title
Starchy meals
Arm Type
Experimental
Arm Description
This arm contains a 4-way cross-over intervention study with
Intervention Type
Other
Intervention Name(s)
Meat arm
Intervention Description
Randomised sequence of pork, beef, chicken meat, and an egg white/pea combination
Intervention Type
Other
Intervention Name(s)
Starchy foods arm
Intervention Description
Randomised sequence of boiled potato, fried potato, potato crisps, and boiled white rice
Primary Outcome Measure Information:
Title
meat intake biomarkers
Description
To identify intake biomarkers of general meat, red meat and poultry
Time Frame
0-48 hours
Title
Potato intake biomarkers
Description
To identify intake biomarkers of general potato, fried potato and white rice
Time Frame
0-48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy
Exclusion Criteria:
non-pregnant, no abuse of alcohol or drugs, no chronic medication except p-pills
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catalina Cuparencu, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Lars Dragsted
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
32338001
Citation
Zhou X, Ulaszewska MM, Cuparencu C, De Gobba C, Vazquez-Manjarrez N, Gurdeniz G, Chen J, Mattivi F, Dragsted LO. Urine Metabolome Profiling Reveals Imprints of Food Heating Processes after Dietary Intervention with Differently Cooked Potatoes. J Agric Food Chem. 2020 Jun 3;68(22):6122-6131. doi: 10.1021/acs.jafc.0c01136. Epub 2020 May 8.
Results Reference
background
PubMed Identifier
31141834
Citation
Cuparencu C, Rinnan A, Dragsted LO. Combined Markers to Assess Meat Intake-Human Metabolomic Studies of Discovery and Validation. Mol Nutr Food Res. 2019 Sep;63(17):e1900106. doi: 10.1002/mnfr.201900106. Epub 2019 Jun 13.
Results Reference
result
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Biomarkers of Meats and Potatoes Intake
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