NCT06485960

Brief 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 objective biomarkers and reference methods.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 20, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 9, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 10, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

June 20, 2024

Last Update Submit

December 3, 2025

Conditions

Keywords

Dietary assessmentValidationExperience Samplingdigital healthdigital biomarkersdoubly-labeled waterESM

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    2 weeks

  • Daily energy expenditure derived from the doubly-labeled water method

    Daily energy expenditure (kcal/day) measured by the doubly-labeled water method

    2 weeks

  • Daily dietary protein intake based on urinary nitrogen analysis

    Daily dietary protein intake based on urinary nitrogen analysis

    2 weeks

Secondary Outcomes (5)

  • Dietary intake based on Experience Sampling Dietary Assessment Method

    2 weeks

  • Dietary intake based on 24-hour dietary recalls

    2 weeks

  • Serum Beta-carotenoid concentration

    4 weeks

  • Erythrocyte membrane fatty acid composition

    4 weeks

  • Plasma polyphenol concentration

    4 weeks

Other Outcomes (2)

  • Timing of glucose peaks

    2 weeks

  • Timing of eating-related motion

    2 weeks

Study Arms (1)

YONAS 1

ESDAM validation

Other: ESDAM validation

Interventions

* 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)

YONAS 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adult volunteers

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating women
  • Not following a specific diet for medical reasons (i.e. coeliac disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

Study Officials

  • Christophe Matthys, PhD

    KU Leuven/UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe Matthys, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor dr.

Study Record Dates

First Submitted

June 20, 2024

First Posted

July 3, 2024

Study Start

October 9, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

December 10, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations