Validation StudyVALIDNCT05600530
Validity and Reproducibility of Dietary Assessment Against Objective Measures
An observational study of Validation Study, run by Inge Tetens at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Validation Study
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Oct 2022to 25 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Danish adults
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Validation Study
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days
Secondary outcomes (6)
Validation of energy intake
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).
Measured: 7 days
Validation of vegetable and fruit intake
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.
Measured: 7 days
Validation of whole grain intake
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.
Measured: 7 days
Validation of alcohol intake
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.
Measured: 7 days
Validation of coffee intake
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.
Measured: 7 days
Reproducibility of dietary registration
Agreement between two dietary intake measurements assessed by the self-administered 7-day web-based dietary assessment tool (myfood24) obtained 4 (± 1 week) apart.
Measured: Two times 4 weeks (+/- 1 week) apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start31 Oct 2022
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Tetens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inge Tetens, University of Copenhagen
- Investigators
- Inge Tetens, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600530
- Sponsor's protocol ID
- M243
- Acronym
- VALID
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2022
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reproducibility of A Self-administered Web-based 24-hour Dietary Assessment Tool Among Danish Adults Against Objective Measures
- ClinicalTrials.gov ID
- NCT05600530
- Acronym / sponsor ID
- VALID / M243
- Conditions
- Validation Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Inge TetensUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Danish adults
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
6 secondary outcomes
Validation of energy intake
Time frame: 7 days
Validation of vegetable and fruit intake
Time frame: 7 days
Validation of whole grain intake
Time frame: 7 days
Validation of alcohol intake
Time frame: 7 days
Validation of coffee intake
Time frame: 7 days
Reproducibility of dietary registration
Time frame: Two times 4 weeks (+/- 1 week) apart
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inge Tetens, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation Study, run by Inge Tetens at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of protein intake (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.