Biomarkers of Meats and Potatoes Intake

NCT ID: NCT04548362

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-15

Study Completion Date

2016-05-30

Brief Summary

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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

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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.

Conditions

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Nutrition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

It is not possible to mask foods and for the explorative analysis of results, masking is not required.

Study Groups

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Meat meals

This arm contains a 4-way cross-over intervention study with meats

Group Type EXPERIMENTAL

Meat arm

Intervention Type OTHER

Randomised sequence of pork, beef, chicken meat, and an egg white/pea combination

Starchy meals

This arm contains a 4-way cross-over intervention study with

Group Type EXPERIMENTAL

Starchy foods arm

Intervention Type OTHER

Randomised sequence of boiled potato, fried potato, potato crisps, and boiled white rice

Interventions

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Meat arm

Randomised sequence of pork, beef, chicken meat, and an egg white/pea combination

Intervention Type OTHER

Starchy foods arm

Randomised sequence of boiled potato, fried potato, potato crisps, and boiled white rice

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy

Exclusion Criteria

* non-pregnant, no abuse of alcohol or drugs, no chronic medication except p-pills
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Professor Lars Ove Dragsted

OTHER

Sponsor Role lead

Responsible Party

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Professor Lars Ove Dragsted

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Catalina Cuparencu, PhD

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

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Lars Dragsted

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 32338001 (View on PubMed)

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.

Reference Type RESULT
PMID: 31141834 (View on PubMed)

Other Identifiers

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H-150204011H

Identifier Type: -

Identifier Source: org_study_id

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