- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06485960
Validation of the Experience Sampling Dietary Assessment Method (YONAS)
Validation of the Experience Sampling Dietary Assessment Method (ESDAM)
Study Overview
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christophe Matthys, PhD
- Phone Number: +32 16 34 26 55
- Email: christophe.matthys@uzleuven.be
Study Locations
-
-
Vlaams Brabant
-
Leuven, Vlaams Brabant, Belgium, 3000
- Recruiting
- KU Leuven
-
Contact:
- Christophe Matthys, Professor
- Phone Number: +3216347205
- Email: christophe.matthys@uzleuven.be
-
Contact:
- Joanna M Eksteen, MSc
- Phone Number: +3216347205
- Email: jo.eksteen@kuleuven.be
-
Principal Investigator:
- Christophe Matthys, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
YONAS 1
ESDAM validation
|
|
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
Sponsor
Investigators
- Principal Investigator: Christophe Matthys, PhD, KU Leuven/UZ Leuven
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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