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Набор скоро начнётся NCT07570238

Effect of Gum Acacia and Electrolytes on Hydration After an Exercise-indued Dehydration

Без фазы С лечением Healthy Adult Male

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: Rehydration beverage.
Кому может быть актуально
Состояния в реестре: Healthy Adult Male. Базовые параметры: 18 лет — 40 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
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Официальное название

A Single-blinded, Placebo-controlled, Three-way Crossover Pilot Study, to Assess the Rehydrating Effect of a Nutritional Preparation Containing Gum Acacia Combined With Sea Magnesium After Exercise-induced Dehydration

Обзор

This clinical study is a single-blind, placebo-controlled, three-way cross-over trial evaluating the rehydration efficacy of two nutritional beverages compared to water, after one administration. The investigational products are gum acacia alone, and combined with sea electrolytes as magnesium. Participants, physically active men undergo exercise-induced dehydration followed by controlled rehydration procedure with each product in randomized sequence. The study includes standardized preconditions (diet, hydration, activity control), exercise and rehydration protocols. Gam acacia has the benefit of few preclinic studies in murin models showing significant improvements on electrolytes and water absorption, but its effect on hydration in human has never been evaluated. The combination with sea electrolytes has been developed to optimise and reduce the total concentration of electrolytes into the beverage compared to standard formulations proposed for rehydration in sport application.

Вмешательства

  • Пищевая добавка Rehydration beverage
    On site prepared beverage to replenish 125% of body water loss during the standardized exercise

Первичные конечные точки

  • Fluid retention (%) [Срок оценки: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
Вторичные конечные точки (12)
  • Net fluid balance (ml) [Срок оценки: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Beverage Hydration Index (BHI) [Срок оценки: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Bioelectrical impedance vector analysis (BIVA, L) [Срок оценки: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Bioelectrical impedance vector analysis ratio (ICW/ECW) [Срок оценки: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Urine osmolality (mosmol/kg) [Срок оценки: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Urine Specific Gravity (USG) [Срок оценки: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Urine volume (mL) [Срок оценки: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Electrolytes in urine (mmol/L) [Срок оценки: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Electrolytes in blood (mmol/L) [Срок оценки: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Blood Haemoglobin (g/dL) [Срок оценки: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Blood Haematocrit (%) [Срок оценки: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
  • Plasma volume (%) [Срок оценки: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]

Критерии участия

Критерии включения

  • BMI 18-25
  • Regular physical training on a recreational level
  • Resting pulse rate <100; resting blood pressure <140 mmHg/<100 mmHg

Критерии исключения

  • Participant suffering from acute or recently occurred (in the past 2 weeks) sickness e.g. common cold or gastrointestinal problems
  • Injuries that would limit exercise performance
  • History or presence of cardiovascular, metabolic, endocrine musculoskeletal, autoimmune or renal condition/disorder which per investigator's judgement could interfere with the results of the study or the safety of the participant

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Германия · 1 центр
  • Analyze & Realize GmbH — Berlin

Идентификаторы

NCT: NCT07570238 · FIB12 · Eth-SB-26-023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗