Effekter av drycksvolym, glycerolkoncentration och natriumkoncentration på vätskebalans hos friska euhydratiserade män och kvinnor i vila
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
- Övrig: Placebo beverage, kiwi-strawberry flavor
- Övrig: Electrolyte solution without glycerol beverage 1
- Övrig: Electrolyte solution without glycerol beverage 2
- Övrig: Electrolyte solution without glycerol beverage 3
- Övrig: Electrolyte solution with glycerol beverage 1
- Övrig: Electrolyte solution with glycerol beverage 2
- Övrig: Electrolyte solution with glycerol beverage 3
- Övrig: Base with glycerol, no electrolytes beverage 1
- Övrig: Base with glycerol, no electrolytes beverage 2
- Övrig: Base with glycerol, no electrolytes beverage 3
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Florida
-
Bradenton, Florida, Förenta staterna, 34210
- IMG Academy/GSSI Bradenton Gatorade Sports Science Institute
-
St. Petersburg, Florida, Förenta staterna, 33705
- GCP Research
-
-
New York
-
Valhalla, New York, Förenta staterna, 10595
- Gatorade Sports Science Institute
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: 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 |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fluid balance
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Urine mass
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: Screening visit
|
Current status (e.g., contraception, regular periods or not, etc.) |
Screening visit
|
|
Adverse Events
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Lindsay Baker, PhD, PepsiCo R&D/Gatorade and Sports Science Institute
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PEP-2420
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