- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05600530
Validity and Reproducibility of Dietary Assessment Against Objective Measures (VALID)
October 5, 2023 updated by: Inge Tetens
Validity and Reproducibility of A Self-administered Web-based 24-hour Dietary Assessment Tool Among Danish Adults Against Objective Measures
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Healthy volunteers (age 35-70 yrs; BMI 22-32) will be recruited for the study.
Informed consent will be obtained and participants will complete a self-administered web-based 7-day 24-hour dietary recall tool (myfood24®).Validity of this dietary registration tool will be assessed by comparing the estimated intake of selected nutrients (protein, energy) and selected food groups (fruit and vegetables, whole grain, coffee, alcoholic beverages) against objective biomarkers obtained from a 24-hour urine sample, through a measurement of resting energy metabolic rate, and from a fasting blood sample, respectively.
Reproducibility will be assessed by comparison of the results from two self-administered web-based 7-day 24-hour dietary recalls obtained 4 weeks (± 1 weeks) apart.
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DK
-
Frederiksberg, DK, Denmark, 1958
- University of Copenhagen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Healthy Danish adults
Description
Inclusion criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validation of protein intake
Time Frame: 7 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validation of energy intake
Time Frame: 7 days
|
Agreement between mean energy intake per day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and resting metabolic rate (measured by ventilated hood).
|
7 days
|
|
Validation of vegetable and fruit intake
Time Frame: 7 days
|
Agreement between mean intake of vegetable and fruit per day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and concentration of folate in a fasting blood sample.
|
7 days
|
|
Validation of whole grain intake
Time Frame: 7 days
|
Agreement between intake of whole grain per day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and excretion of alkylresorcinols in a fasting blood sample.
|
7 days
|
|
Validation of alcohol intake
Time Frame: 7 days
|
Agreement between mean alcohol intake pr day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and excretion of ethanol and ethyl conjugates in a 24-hr urine sample.
|
7 days
|
|
Validation of coffee intake
Time Frame: 7 days
|
Agreement between mean coffee intake per day assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) and excretion of trigonelline and cyclo(isoleucylprolyl) in a 24-hr urine sample.
|
7 days
|
|
Reproducibility of dietary registration
Time Frame: Two times 4 weeks (+/- 1 week) apart
|
Agreement between two dietary intake measurements assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) obtained 4 (± 1 week) apart.
|
Two times 4 weeks (+/- 1 week) apart
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Inge Tetens, PhD, Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2022
Primary Completion (Actual)
August 25, 2023
Study Completion (Actual)
August 25, 2023
Study Registration Dates
First Submitted
October 12, 2022
First Submitted That Met QC Criteria
October 26, 2022
First Posted (Actual)
October 31, 2022
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
October 5, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- M243
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.