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Clinical Trials/NCT06485960
NCT06485960
Recruiting
Not Applicable

Validation of the Experience Sampling Dietary Assessment Method (ESDAM)

KU Leuven1 site in 1 country115 target enrollmentOctober 9, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Validation Study
Sponsor
KU Leuven
Enrollment
115
Locations
1
Primary Endpoint
Daily dietary energy intake based on the Experience Sampling Dietary Assessment Method
Status
Recruiting
Last Updated
4 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 9, 2025
End Date
March 1, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Christophe Matthys

Professor dr.

KU Leuven

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Dietary intake based on Experience Sampling Dietary Assessment Method(2 weeks)
  • Serum Beta-carotenoid concentration(4 weeks)
  • Dietary intake based on 24-hour dietary recalls(2 weeks)
  • Erythrocyte membrane fatty acid composition(4 weeks)
  • Plasma polyphenol concentration(4 weeks)

Study Sites (1)

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