Clinical trial NCT06485960: Validation of the Experience Sampling Dietary Assessment Method
Official title: Validation of the Experience Sampling Dietary Assessment Method (ESDAM)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Validation Study
Keywords: Dietary assessment
Validation
Experience Sampling
digital health
digital biomarkers
doubly-labeled water
ESM
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers

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 a. 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) together with continuous glucose monitoring.

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)

Primary outcomes:
measure: Daily dietary energy intake based on the Experience Sampling Dietary Assessment Method
timeFrame: 2 weeks
measure: Daily dietary protein intake based on the Experience Sampling Dietary Assessment Method
timeFrame: 2 weeks
measure: Daily energy expenditure derived from the doubly-labeled water method
timeFrame: 2 weeks
measure: Daily dietary protein intake based on urinary nitrogen analysis
timeFrame: 2 weeks
Secondary outcomes:
measure: Dietary intake based on Experience Sampling Dietary Assessment Method
timeFrame: 2 weeks
measure: Dietary intake based on 24-hour dietary recalls
timeFrame: 2 weeks
measure: Serum Beta-carotenoid concentration
timeFrame: 4 weeks
measure: Erythrocyte membrane fatty acid composition
timeFrame: 4 weeks
Other outcomes:
measure: Timing of glucose peaks
timeFrame: 2 weeks
Locations:
Study officials:
affiliation: KU Leuven/UZ Leuven
name: Christophe Matthys, PhD
role: PRINCIPAL_INVESTIGATOR
References: