Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest

Обзор

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.

Вмешательства

• Другое Placebo beverage, kiwi-strawberry flavor
  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
• Другое Electrolyte solution without glycerol beverage 1
  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.
• Другое Electrolyte solution without glycerol beverage 2
  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.
• Другое Electrolyte solution without glycerol beverage 3
  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.
• Другое Electrolyte solution with glycerol beverage 1
  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.
• Другое Electrolyte solution with glycerol beverage 2
  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.
• Другое Electrolyte solution with glycerol beverage 3
  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.
• Другое Base with glycerol, no electrolytes beverage 1
  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.
• Другое Base with glycerol, no electrolytes beverage 2
  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.
• Другое Base with glycerol, no electrolytes beverage 3
  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.

Первичные конечные точки

• Fluid balance [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes]

Вторичные конечные точки (12)

• Urine mass [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes]
• Urine specific gravity [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes]
• Urine osmolality [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes]
• Whole blood hematocrit [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
• Whole blood hemoglobin concentration [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
• Serum sodium concentration [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
• Serum potassium concentration [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
• Serum chloride concentration (mmol/L) [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
• Serum glucose concentration [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
• Serum glycerol concentration [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
• Serum copeptin concentration [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]
• Serum osmolality [Срок оценки: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

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

Четверное слепое

Основная цель

Другое

Центры проведения

США · 3 центра

• IMG Academy/GSSI Bradenton Gatorade Sports Science Institute — Bradenton
• GCP Research — St. Petersburg
• Gatorade Sports Science Institute — Valhalla

Идентификаторы

NCT: NCT06854471 · PEP-2420

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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