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Идёт набор NCT06485960

Validation of the Experience Sampling Dietary Assessment Method

— Наблюдательное Validation Study

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ESDAM validation.
Кому может быть актуально
Состояния в реестре: Validation Study. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
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Официальное название

Validation of the Experience Sampling Dietary Assessment Method (ESDAM)

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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)

Первичные конечные точки

  • Daily dietary energy intake based on the Experience Sampling Dietary Assessment Method [Срок оценки: 2 weeks]
  • Daily dietary protein intake based on the Experience Sampling Dietary Assessment Method [Срок оценки: 2 weeks]
  • Daily energy expenditure derived from the doubly-labeled water method [Срок оценки: 2 weeks]
  • Daily dietary protein intake based on urinary nitrogen analysis [Срок оценки: 2 weeks]
Вторичные конечные точки (5)
  • Dietary intake based on Experience Sampling Dietary Assessment Method [Срок оценки: 2 weeks]
  • Dietary intake based on 24-hour dietary recalls [Срок оценки: 2 weeks]
  • Serum Beta-carotenoid concentration [Срок оценки: 4 weeks]
  • Erythrocyte membrane fatty acid composition [Срок оценки: 4 weeks]
  • Plasma polyphenol concentration [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бельгия · 1 центр
  • KU Leuven — Leuven

Публикации

  • Verbeke J, Verbeke K, Van der Schueren B, Vangoitsenhoven R, Matthys C. Protocol of the validation of the experience sampling-based dietary assessment method (ESDAM) against doubly labeled water, urinary protein, and biomarkers. Nutr J. 2025 Nov 5;24(1):169. doi: 10.1186/s12937-025-01232-3. PMID 41194100

Идентификаторы

NCT: NCT06485960 · S68363 · C3/22/050

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗