NCT05600530

Brief Summary

A cross-sectional study with repeated measurements among healthy Danish adults to assess the validity and reproducibility of a self-administered 7-day web-based dietary assessment tool, myfood24® tested against objective biomarkers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

October 12, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 12, 2022

Last Update Submit

October 5, 2023

Conditions

Validation Study

Outcome Measures

Primary Outcomes (1)

  • Validation of protein intake

    Agreement between mean protein intake per day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and nitrogen excretion in a 24-hr urine sample (urea corrected for creatine).

    7 days

Secondary Outcomes (6)

  • Validation of energy intake

    7 days

  • Validation of vegetable and fruit intake

    7 days

  • Validation of whole grain intake

    7 days

  • Validation of alcohol intake

    7 days

  • Validation of coffee intake

    7 days

  • +1 more secondary outcomes

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Danish adults

You may qualify if:

  • Apparently healthy adults between 35 and 70 years old
  • Body mass index (BMI) between 22-32 kg/m2
  • Weight stable defined as gain or loss of \< 2.5% body weight during the past 3 months;
  • Willingness to maintain current dietary and physical activity habits throughout the study period.
  • Have high-speed internet access;
  • Able to speak, read and write Danish;
  • Willing to visit the Department of Nutrition, Exercise, and Sports (NEXS).

You may not qualify if:

  • Clinically diagnosed chronic disease,
  • use of corticosteroids or other medication that would potentially affect the nutrient metabolism or excretion of biomarkers of interest,
  • presence of food allergy or intolerance that requires a special diet,
  • pregnancy and lactation,
  • excess physical activity (\>5h/week of high intensity),
  • current participation in another trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Frederiksberg, DK, 1958, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood samples to measure biomarker excretion

Study Officials

  • Inge Tetens, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 31, 2022

Study Start

October 31, 2022

Primary Completion

August 25, 2023

Study Completion

August 25, 2023

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

DK(1)