Validation StudyYONASNCT06485960
Validation of the Experience Sampling Dietary Assessment Method
An observational study of Validation Study, run by KU Leuven at 1 site in Belgium.
Trial summary
A new dietary assessment method was developed based on the Experience Sampling Methodology. In order to use this newly developed Experience Sampling Dietary Assessment Method (ESDAM) in research and clinical practice as a valid and reliable method to measure dietary intake the ESDAM needs to be validated against… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Validation Study
- What is being tested?
- ESDAM validation
- How many people
- 115 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Oct 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers
Who may be able to join
- Signed informed consent
- Having a smartphone and being capable of using the smartphone and apps
- Having a freezer at home
- Sufficient knowledge of the Dutch language to understand and participate in the study
- Having a stable body weight (body weight not changed by 5% last 3 months)
- Not aiming to gain or lose weight during the study period
Who cannot join
- Pregnant or lactating women
- Not following a specific diet for medical reasons (i.e. coeliac disease)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven, Vlaams Brabant, 3000
Christophe Matthys, Professor, +3216347205, christophe.matthys@uzleuven.be
Joanna M Eksteen, MSc, +3216347205, jo.eksteen@kuleuven.be
About this study
Official title: Validation of the Experience Sampling Dietary Assessment Method (ESDAM)
A new dietary assessment method was developed based on the Experience Sampling Methodology. In order to use this newly developed Experience Sampling Dietary Assessment Method (ESDAM) in research and clinical practice as a valid and reliable method to measure dietary intake the ESDAM needs to be validated against objective biomarkers and reference methods.
Read the detailed description
The purpose of this research project is to advance nutritional research by delivering an improved, accurate, feasible and reliable method to assess dietary intake. Our newly developed approach to collate dietary intake based on experience sampling methodology (ESM) will serve this purpose.
Therefore, this research aims to validate the newly developed Experience Sampling Dietary Assessment Method (ESDAM) by assessing construct validity compared to blood and urine biomarkers representing dietary intake. This will eventually result in the newly developed dietary assessment method being evidence-based and validated and, thus, ready-to-use as a reliable method for research and clinical practice.
Therefore, the ESDAM will be validated against repeated 24-hour dietary recalls, the doubly-labelled water method, urinary nitrogen and blood biomarkers. The study has a duration of four weeks. The first two weeks will be used to collect baseline data including socio-demographic, biometric data and three 24-hour recalls to assess dietary intake. During the last two weeks the Experience Sampling Dietary Assessment Method will be evaluated against urine biomarkers (Doubly-labeled water and urinary nitrogen), blood biomarkers (erythrocyte membrane fatty acid composition, beta-carotenoids, polyphenols) together with continuous glucose monitoring and two wrist-worn motion sensor devices to track eating- related movements.
- Conditions
- Validation Study
- Being tested
- ESDAM validation
- Keywords
- Dietary assessment, Validation, Experience Sampling, digital health, digital biomarkers, doubly-labeled water, ESM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESDAM validationOther
- 3* 24-Hour Dietary Recalls
- Experience Sampling Dietary Assessment Method (mobile application)
- Continuous Blood Glucose Monitoring
- Wrist- worn motion sensors
- Doubly-labeled water administration
- Blood drawings (Erythrocyte Membrane Fatty Acid composition, Carotenoids, polyphenols)
- Urine sampling (Doubly-labeled water, urinary nitrogen)
| Study group | Role | What they receive |
|---|---|---|
| YONAS 1 | ESDAM validation Receives: Other: ESDAM validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily dietary energy intake based on the Experience Sampling Dietary Assessment Method
Daily dietary energy intake estimated by the Experience Sampling Dietary Assessment Method (ESDAM) compared to the Doubly-labeled Water Method
Measured: 2 weeks
Daily dietary protein intake based on the Experience Sampling Dietary Assessment Method
Daily dietary protein intake estimated by the Experience Sampling Dietary Assessment Method (ESDAM) compared to urinary nitrogen
Measured: 2 weeks
Daily energy expenditure derived from the doubly-labeled water method
Daily energy expenditure (kcal/day) measured by the doubly-labeled water method
Measured: 2 weeks
Daily dietary protein intake based on urinary nitrogen analysis
Daily dietary protein intake based on urinary nitrogen analysis
Measured: 2 weeks
Secondary outcomes (5)
Dietary intake based on Experience Sampling Dietary Assessment Method
Daily nutrient and food group consumption estimated by the Experience Sampling Dietary Assessment Method ESDAM
Measured: 2 weeks
Dietary intake based on 24-hour dietary recalls
Energy, nutrient and food group consumption measured by the 24-hour dietary recalls
Measured: 2 weeks
Serum Beta-carotenoid concentration
Serum Beta-carotenoids as biomarker of fruit and vegetable consumption
Measured: 4 weeks
Erythrocyte membrane fatty acid composition
Erythrocyte membrane fatty acid composition as biomarker of fatty acid consumption
Measured: 4 weeks
Plasma polyphenol concentration
Plasma polyphenol concentration as an indication of dietary polyohenol intake
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start9 Oct 2025
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Matthys, KU Leuven
- Investigators
- Christophe Matthys, PhD, Principal investigator, KU Leuven/UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485960
- Sponsor's protocol ID
- S68363
- Other IDs
- C3/22/050
- Acronym
- YONAS
- Status last verified
- Aug 2025
- First submitted
- 20 Jun 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verbeke J, Verbeke K, Van der Schueren B, Vangoitsenhoven R, Matthys C. Protocol of the validation of the experience sampling-based dietary assessment method (ESDAM) against doubly labeled water, urinary protein, and biomarkers. Nutr J. 2025 Nov 5;24(1):169. doi: 10.1186/s12937-025-01232-3.
PubMed 41194100
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Experience Sampling Dietary Assessment Method (ESDAM)
- ClinicalTrials.gov ID
- NCT06485960
- Acronym / sponsor ID
- YONAS / S68363
- Conditions
- Validation Study
- Keywords
- Dietary assessment, Validation, Experience Sampling, digital health, digital biomarkers, doubly-labeled water, ESM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 3 Jul 2024 (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 new dietary assessment method was developed based on the Experience Sampling Methodology. In order to use this newly developed Experience Sampling Dietary Assessment Method (ESDAM) in research and clinical practice as a valid and reliable method to measure dietary intake the ESDAM needs to be validated against objective biomarkers and reference methods.
Detailed description
The purpose of this research project is to advance nutritional research by delivering an improved, accurate, feasible and reliable method to assess dietary intake. Our newly developed approach to collate dietary intake based on experience sampling methodology (ESM) will serve this purpose.
Therefore, this research aims to validate the newly developed Experience Sampling Dietary Assessment Method (ESDAM) by assessing construct validity compared to blood and urine biomarkers representing dietary intake. This will eventually result in the newly developed dietary assessment method being evidence-based and validated and, thus, ready-to-use as a reliable method for research and clinical practice.
Therefore, the ESDAM will be validated against repeated 24-hour dietary recalls, the doubly-labelled water method, urinary nitrogen and blood biomarkers. The study has a duration of four weeks. The first two weeks will be used to collect baseline data including socio-demographic, biometric data and three 24-hour recalls to assess dietary intake. During the last two weeks the Experience Sampling Dietary Assessment Method will be evaluated against urine biomarkers (Doubly-labeled water and urinary nitrogen), blood biomarkers (erythrocyte membrane fatty acid composition, beta-carotenoids, polyphenols) together with continuous glucose monitoring and two wrist-worn motion sensor devices to track eating- related movements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YONAS 1 | – | Other: ESDAM validationESDAM validation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers
Key inclusion criteria (6 listed)
- Signed informed consent
- Having a smartphone and being capable of using the smartphone and apps
- Having a freezer at home
- Sufficient knowledge of the Dutch language to understand and participate in the study
- Having a stable body weight (body weight not changed by 5% last 3 months)
Key exclusion criteria (2 listed)
- Pregnant or lactating women
- Not following a specific diet for medical reasons (i.e. coeliac disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESDAM validation* 3* 24-Hour Dietary Recalls * Experience Sampling Dietary Assessment Method (mobile application) * Continuous Blood Glucose Monitoring * Wrist- worn motion sensors * Doubly-labeled water administration * Blood drawings (Erythrocyte Membrane Fatty Acid composition, Carotenoids, polyphenols) * Urine sampling (Doubly-labeled water, urinary nitrogen) | Other | YONAS 1 |
Primary outcome
Daily dietary energy intake based on the Experience Sampling Dietary Assessment Method
Time frame: 2 weeks
Daily dietary energy intake estimated by the Experience Sampling Dietary Assessment Method (ESDAM) compared to the Doubly-labeled Water Method
Daily dietary protein intake based on the Experience Sampling Dietary Assessment Method
Time frame: 2 weeks
Daily dietary protein intake estimated by the Experience Sampling Dietary Assessment Method (ESDAM) compared to urinary nitrogen
Daily energy expenditure derived from the doubly-labeled water method
Time frame: 2 weeks
Daily energy expenditure (kcal/day) measured by the doubly-labeled water method
Daily dietary protein intake based on urinary nitrogen analysis
Time frame: 2 weeks
Daily dietary protein intake based on urinary nitrogen analysis
5 secondary outcomes
Dietary intake based on Experience Sampling Dietary Assessment Method
Time frame: 2 weeks
Dietary intake based on 24-hour dietary recalls
Time frame: 2 weeks
Serum Beta-carotenoid concentration
Time frame: 4 weeks
Erythrocyte membrane fatty acid composition
Time frame: 4 weeks
Plasma polyphenol concentration
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 41194100Verbeke J, Verbeke K, Van der Schueren B, Vangoitsenhoven R, Matthys C. Protocol of the validation of the experience sampling-based dietary assessment method (ESDAM) against doubly labeled water, urinary protein, and biomarkers. Nutr J. 2025 Nov 5;24(1):169. doi: 10.1186/s12937-025-01232-3.
- Individual participant dataSharing planned: No
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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.
Christophe Matthys, PhD principal investigator
KU Leuven/UZ Leuven
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 KU Leuven at 1 site in Belgium.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Dec 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Matthys, PhD (+32 16 34 26 55, christophe.matthys@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily dietary energy intake based on the Experience Sampling Dietary Assessment Method (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485960, which also lists 1 linked publication.
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 10 Dec 2025.