Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-08 @ 1:35 AM
Study NCT ID:
NCT06485960
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2024-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Experience Sampling Dietary Assessment Method
Sponsor:
KU Leuven
Organization:
Study Overview
Official Title:
Validation of the Experience Sampling Dietary Assessment Method (ESDAM)
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YONAS
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| C3/22/050 | OTHER_GRANT | KU Leuven | View |