NCT04548362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2016

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

September 7, 2020

Last Update Submit

April 26, 2021

Conditions

Keywords

Biomarkers of food intake

Outcome Measures

Primary Outcomes (2)

  • meat intake biomarkers

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

    0-48 hours

  • Potato intake biomarkers

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

    0-48 hours

Study Arms (2)

Meat meals

EXPERIMENTAL

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

Other: Meat arm

Starchy meals

EXPERIMENTAL

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

Other: Starchy foods arm

Interventions

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

Meat meals

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

Starchy meals

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lars Dragsted

Frederiksberg, 1958, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 32338001BACKGROUND
  • 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.

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Catalina Cuparencu, PhD

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
It is not possible to mask foods and for the explorative analysis of results, masking is not required.
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

February 15, 2016

Primary Completion

May 30, 2016

Study Completion

May 30, 2016

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
1 year
Access Criteria
after contact with PI; only anonymized information will be provided.

Locations