Dynamic Monitoring of Urinary Electrolytes
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: Urinary electrolyte, fruit diet, nut diet, calcium supplement diet.
- Кому может быть актуально
- Состояния в реестре: Healthy. Базовые параметры: 18 лет — 60 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This interventional device feasibility study evaluates the operational feasibility of a prototype urinary electrolyte monitoring device in healthy adults aged 18 to 60 years. Urine samples will be collected during protocol-defined dietary intervention conditions and free-living conditions to determine whether the prototype device can generate complete urinary sodium, chloride, potassium, magnesium, and calcium measurement results without device malfunction, sample-processing failure, unreadable signal output, or repeat device operation. Dietary intervention conditions are used to provide physiologic variation in urinary electrolyte levels and to create testing conditions for the prototype device. The primary outcome is the valid measurement rate of the prototype device across collected urine samples. Secondary outcomes will summarize changes in urinary electrolyte levels following dietary interventions and within-participant variability under free-living conditions. Participants will provide baseline anthropometric and physiological data, including height, weight, age, and blood pressure, along with baseline fasting morning urine samples. Participants will consume assigned standardized meals or provide urine samples under free-living conditions, depending on study arm assignment. Longitudinal urine samples will be collected at protocol-defined time points, such as post-prandial intervals or other scheduled collection times during the study period.
Вмешательства
- Устройство Urinary electrolyte
Urine is collected and tested on the device. - Пищевая добавка fruit diet
Participants will consume assigned standardized meals including fruit. - Пищевая добавка nut diet
Participants will consume assigned standardized meals including nut. - Пищевая добавка calcium supplement diet
Participants will consume assigned standardized meals including calcium supplements. - Пищевая добавка DASH diet
Participants will consume assigned low salt high fruit meals following DASH diet guidance.
Первичные конечные точки
- Prototype Device Valid Measurement Rate for Urinary Electrolyte Analysis [Срок оценки: Up to 2 weeks after study arm assignment.]
Вторичные конечные точки (5)
- Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the high-fruit dietary intervention [Срок оценки: Baseline, 1 hour, 2 hours, 3 hours, and 4 hours after the high-fruit dietary intervention.]
- Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the high-nut dietary intervention [Срок оценки: Baseline, 1 hour, 2 hours, 3 hours, and 4 hours after the high-nut dietary intervention.]
- Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the calcium supplementation dietary intervention [Срок оценки: Baseline, 1 hour, 2 hours, 3 hours, and 4 hours after the calcium supplementation dietary intervention.]
- Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the DASH dietary intervention [Срок оценки: Baseline and daily for up to 2 weeks during the DASH dietary intervention.]
- Within-participant variability in urinary sodium, chloride, potassium, magnesium, and calcium levels under free-living conditions [Срок оценки: Daily for up to 1 week under free-living conditions.]
Критерии участия
Критерии включения
- Adults aged between 18- and 60-year-old
- Willing to join and complete the study
Критерии исключения
- Medical conditions, such as liver, kidney, gastrointestinal, or systemic diseases;
- Drug taking or use within two weeks;
- Pregnant women;
- Lack of access to a smartphone
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Оценка устройства
Центры проведения
Китай · 1 центр
- Westlake University — Ханчжоу
Идентификаторы
NCT: NCT07704450 · 20260114LHS001 · 20260521LHS001