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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04548362
Other study ID # H-150204011H
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2016
Est. completion date May 30, 2016

Study information

Verified date April 2021
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date May 30, 2016
Est. primary completion date May 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - healthy Exclusion Criteria: - non-pregnant, no abuse of alcohol or drugs, no chronic medication except p-pills

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Meat arm
Randomised sequence of pork, beef, chicken meat, and an egg white/pea combination
Starchy foods arm
Randomised sequence of boiled potato, fried potato, potato crisps, and boiled white rice

Locations

Country Name City State
Denmark Lars Dragsted Frederiksberg

Sponsors (1)

Lead Sponsor Collaborator
Professor Lars Ove Dragsted

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Cuparencu C, Rinnan Å, 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. — View Citation

Zhou X, Ulaszewska MM, Cuparencu C, De Gobba C, Vázquez-Manjarrez N, Gürdeniz 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary meat intake biomarkers To identify intake biomarkers of general meat, red meat and poultry 0-48 hours
Primary Potato intake biomarkers To identify intake biomarkers of general potato, fried potato and white rice 0-48 hours
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