Влияние объема напитков, концентрации глицерина и концентрации натрия на баланс жидкости у здоровых мужчин и женщин с эугидратированным
The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination.
The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes on fluid balance in healthy, euhydrated men and women.
Обзор исследования
Статус
Условия
Вмешательство/лечение
- Другой: Placebo beverage, kiwi-strawberry flavor
- Другой: Electrolyte solution without glycerol beverage 1
- Другой: Electrolyte solution without glycerol beverage 2
- Другой: Electrolyte solution without glycerol beverage 3
- Другой: Electrolyte solution with glycerol beverage 1
- Другой: Electrolyte solution with glycerol beverage 2
- Другой: Electrolyte solution with glycerol beverage 3
- Другой: Base with glycerol, no electrolytes beverage 1
- Другой: Base with glycerol, no electrolytes beverage 2
- Другой: Base with glycerol, no electrolytes beverage 3
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Florida
-
Bradenton, Florida, Соединенные Штаты, 34210
- IMG Academy/GSSI Bradenton Gatorade Sports Science Institute
-
St. Petersburg, Florida, Соединенные Штаты, 33705
- GCP Research
-
-
New York
-
Valhalla, New York, Соединенные Штаты, 10595
- Gatorade Sports Science Institute
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Subject is male or female
- If female, subject is not pregnant
- Subject is 18-50 years of age, inclusive
- Subject is at least recreationally active (engaged in light to moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)
- Subject does not smoke (or has quit for at least 6 months)
- Subject is not taking medication that may interfere with the study (e.g., diuretics)
- Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases)
- Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
- Subject is willing to fast overnight (~8-12 hours)
- Subject is willing to refrain from vigorous exercise for 24 hours
- Subject is willing to eat the exact same food the day prior to each visit to the laboratory
- Provision of written consent to participate
Exclusion Criteria:
- Subject has participated in a clinical trial within the past 30 days
- Subject has participated in any PepsiCo trial within past 6 months
- Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
- Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Плацебо Компаратор: Placebo beverage
Base beverage, no electrolytes, no glycerol |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose |
|
Экспериментальный: Electrolyte solution without glycerol beverage 1
Higher electrolytes lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: Electrolyte solution without glycerol beverage 2
Lower electrolytes mid-volume |
6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: Electrolyte solution without glycerol beverage 3
Higher electrolytes higher volume |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: Electrolyte solution with glycerol beverage 1
Lower electrolytes, lower glycerol, lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: Electrolyte solution with glycerol beverage 2
Higher electrolytes, higher glycerol, lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: Electrolyte solution with glycerol beverage 3
Higher electrolytes, higher glycerol, higher volume |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: Base with glycerol beverage 1
No electrolytes, higher glycerol, lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: Base with glycerol beverage 2
No electrolytes, lower glycerol, mid-volume |
6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: Base with glycerol beverage 3
No electrolytes, higher glycerol, higher volume |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Fluid balance
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
Calculated as change in body mass kg and % |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Urine mass
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(g) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Urine specific gravity
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(au) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Urine osmolality
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(mosmol/kg) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Whole blood hematocrit
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(%) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Whole blood hemoglobin concentration
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(g/dl) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum sodium concentration
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum potassium concentration
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum chloride concentration (mmol/L)
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum glucose concentration
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mg/dl) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum glycerol concentration
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum copeptin concentration
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(pmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum osmolality
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mosmol/kg) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Blood pressure
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(systolic/diastolic) (mmHg) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Heart rate
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(bpm) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Subjective measures of gastrointestinal discomfort and headache (VAS)
Временное ограничение: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
Rated on a 100 point scale from none to severe for headache, lightheaded, stomach upset, nausea, burping, stomach bloating, abdominal discomfort, stomach fullness, vomiting, diarrhea). |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Menstrual categorization
Временное ограничение: Screening visit
|
Current status (e.g., contraception, regular periods or not, etc.) |
Screening visit
|
|
Adverse Events
Временное ограничение: From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6)
|
Documented changes in health and symptoms |
From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6)
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Lindsay Baker, PhD, PepsiCo R&D/Gatorade and Sports Science Institute
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- PEP-2420
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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