Влияние добавления глицерина к электролитным напиткам на баланс жидкости у здоровых эугидратированных мужчин и женщин в состоянии покоя
The results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention. In addition, inclusion of glycerol resulted in an upward shift in the relationship between sodium concentration and fluid balance. The practical interpretation is that addition of glycerol enables a reduction in sodium concentration compared with a 0% glycerol drink.
In this follow-up study, the investigators hypothesize that 1) fluid balance will be sustained (greater than or not different from baseline) and significantly greater than placebo for 120 min after drinking the test no/low/moderate carbohydrate beverages and 2) fluid balance will not differ between the carbohydrate-electrolyte beverages, but both will be greater than placebo.
Обзор исследования
Статус
Условия
Вмешательство/лечение
- Другой: Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2)
- Другой: 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)
- Другой: 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)
- Другой: 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
- Другой: 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
- Другой: 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)
- Другой: 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)
Подробное описание
This is a two-part study. Subjects will be asked to complete either Part 1 or Part 2 of this study. Subjects can participate in both parts of the study if they are interested and available to complete all trials. However, they will be asked to complete Part 1 before enrolling in Part 2 of the study. Dosing days are separated by 2-15 days.
Objective 1) To compare the effect of consumption of four no/low/moderate carbohydrate drinks with high electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=25
Objective 2) To compare the effect of consumption of two moderate carbohydrate drinks with low electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=70
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
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New York
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Valhalla, New York, Соединенные Штаты, 10595
- PepsiCo R&D, Gatorade Sports Science Institute
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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 (based on self-report)
- 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, As indicated on the general health questionnaire (GHQ), e.g. cardiovascular, renal, or metabolic diseases
- Subject is not allergic to adhesives (e.g., medical tape)
- Subject is not allergic to kiwi-strawberry flavoring
- 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 (light physical activity only)
- Subject is willing to eat the exact same food the day prior to each visit to the laboratory
- Able to speak, write, and read English
- 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: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 0% раствор углеводного электролита с глицериновым напитком (только часть 1)
|
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: 0% раствор углеводного электролита без глицеринового напитка (только часть 1)
|
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: 6% раствор углеводного электролита без глицеринового напитка (только часть 2)
|
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Плацебо Компаратор: Плацебо напиток (части 1 и 2)
|
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. |
|
Экспериментальный: 1% раствор электролита углеводов с напитком глицерина (детали 1 и 2)
|
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: 6% раствор электролита углеводов с напитком глицерина (детали 1 и 2)
|
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
Экспериментальный: 2% углеводный раствор электролита без напитков глицерина (только часть 2)
|
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) 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 (Body Weight)
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Platform scale to the nearest 0.005 kilograms (kg) |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Fluid balance (Percent (%) change in Body Mass)
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Platform scale to the nearest 0.005 kilograms (kg) |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Fluid retention
Временное ограничение: % change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Platform scale to the nearest 0.005 kilograms (kg), unit percent (%) |
% change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Urine mass
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Graduated cylinder on scale to the nearest 0.01 grams |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Urine specific gravity
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
USG digital pen refractometer (Atago), no unit |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Blood sodium
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Fingerstick sampling, unit millimoles per liter (mmol/L), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge) |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Blood glucose
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Fingerstick sampling, unit milligrams per deciliter (mg/dl), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge) |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Percent change in plasma volume
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Fingerstick sampling, calculated from hematocrit and hemoglobin concentration percent (%) |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Serum glycerol concentration
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Fingerstick sampling unit millimoles per liter (mmol/L) using Sigma Aldrich glycerol assay kit |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Serum osmolality
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Fingerstick sampling, unit milliosmoles per kilogram of water (mOsm/Kg H20) |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Saliva osmolality
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Measured directly from the tongue using a handheld MX3 Diagnostics device, unit milliosmoles per kilogram of water (mOsm/kg H2O) |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Blood pressure (systolic/diastolic)
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Automatic sphygmomanometer unit millimeters of mercury (mm/Hg) |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Heart rate
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Heart rate monitor, unit beats per minute (bpm) |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Subjective measure of headache
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
One item on a 100 point visual analog scale anchored from 0=No headache to 100=Severe headache |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Subjective measure of lightheadedness
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
One item on a 100 point visual analog scale anchored from 0=No lightheadedness to 100=Severe lightheadedness |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Subjective measures of gastrointestinal discomfort
Временное ограничение: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
Eight items on a 100 point visual analog scale (stomach upset, nausea, burping, stomach bloating, abdominal discomfort, stomach fullness, vomiting, diarrhea anchored frrom 0= None to 100=Severe |
Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
|
|
Menstrual categorization
Временное ограничение: Assessed at Screening Visit
|
Using Elliott-Sale chart, 2023 to categorize menstrual/hormonal contraceptive status for those who have not yet reached perimenopause/menopause. This is a decision-tree chart, not a scale. |
Assessed at Screening Visit
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Lindsay Baker, PhD, PepsiCo R&D Life Sciences, Sports Science
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
Другие идентификационные номера исследования
- PEP-2412
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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