Efectos del volumen de bebidas, la concentración de glicerol y la concentración de sodio en el equilibrio de líquidos en hombres y mujeres euhidratados saludables en reposo
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Otro: Placebo beverage, kiwi-strawberry flavor
- Otro: Electrolyte solution without glycerol beverage 1
- Otro: Electrolyte solution without glycerol beverage 2
- Otro: Electrolyte solution without glycerol beverage 3
- Otro: Electrolyte solution with glycerol beverage 1
- Otro: Electrolyte solution with glycerol beverage 2
- Otro: Electrolyte solution with glycerol beverage 3
- Otro: Base with glycerol, no electrolytes beverage 1
- Otro: Base with glycerol, no electrolytes beverage 2
- Otro: Base with glycerol, no electrolytes beverage 3
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Bradenton, Florida, Estados Unidos, 34210
- IMG Academy/GSSI Bradenton Gatorade Sports Science Institute
-
St. Petersburg, Florida, Estados Unidos, 33705
- GCP Research
-
-
New York
-
Valhalla, New York, Estados Unidos, 10595
- Gatorade Sports Science Institute
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: 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 |
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fluid balance
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Urine mass
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Screening visit
|
Current status (e.g., contraception, regular periods or not, etc.) |
Screening visit
|
|
Adverse Events
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lindsay Baker, PhD, PepsiCo R&D/Gatorade and Sports Science Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PEP-2420
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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