Validation of the Experience Sampling Dietary Assessment Method (YONAS)

December 3, 2025 updated by: Christophe Matthys, KU Leuven

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Recruiting
        • KU Leuven
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christophe Matthys, Professor

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy adult volunteers

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
YONAS 1
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks
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
2 weeks
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
2 weeks
Daily dietary protein intake based on urinary nitrogen analysis
Time Frame: 2 weeks
Daily dietary protein intake based on urinary nitrogen analysis
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary intake based on Experience Sampling Dietary Assessment Method
Time Frame: 2 weeks
Daily nutrient and food group consumption estimated by the Experience Sampling Dietary Assessment Method ESDAM
2 weeks
Dietary intake based on 24-hour dietary recalls
Time Frame: 2 weeks
Energy, nutrient and food group consumption measured by the 24-hour dietary recalls
2 weeks
Serum Beta-carotenoid concentration
Time Frame: 4 weeks
Serum Beta-carotenoids as biomarker of fruit and vegetable consumption
4 weeks
Erythrocyte membrane fatty acid composition
Time Frame: 4 weeks
Erythrocyte membrane fatty acid composition as biomarker of fatty acid consumption
4 weeks
Plasma polyphenol concentration
Time Frame: 4 weeks
Plasma polyphenol concentration as an indication of dietary polyohenol intake
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of glucose peaks
Time Frame: 2 weeks
Timing of glucose peaks registered by Continuous Glucose Monitoring
2 weeks
Timing of eating-related motion
Time Frame: 2 weeks
Timing of eating-related motion monitored by wrist-worn motion sensors
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Christophe Matthys, PhD, KU Leuven/UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 9, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • S68363
  • C3/22/050 (Other Grant/Funding Number: KU Leuven)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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