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Effekter af drikkevolumen, glycerolkoncentration og natriumkoncentration på væskebalance hos sunde euhydrerede mænd og kvinder i hvile

16. september 2026 opdateret af: PepsiCo Global R&D

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Bradenton, Florida, Forenede Stater, 34210
        • IMG Academy/GSSI Bradenton Gatorade Sports Science Institute
      • St. Petersburg, Florida, Forenede Stater, 33705
        • GCP Research
    • New York
      • Valhalla, New York, Forenede Stater, 10595
        • Gatorade Sports Science Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo beverage

Base beverage, no electrolytes, no glycerol
Andet: 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
Eksperimentel: Electrolyte solution without glycerol beverage 1

Higher electrolytes lower volume
Andet: 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.
Eksperimentel: Electrolyte solution without glycerol beverage 2

Lower electrolytes mid-volume
Andet: 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.
Eksperimentel: Electrolyte solution without glycerol beverage 3

Higher electrolytes higher volume
Andet: 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.
Eksperimentel: Electrolyte solution with glycerol beverage 1

Lower electrolytes, lower glycerol, lower volume
Andet: 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.
Eksperimentel: Electrolyte solution with glycerol beverage 2

Higher electrolytes, higher glycerol, lower volume
Andet: 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.
Eksperimentel: Electrolyte solution with glycerol beverage 3

Higher electrolytes, higher glycerol, higher volume
Andet: 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.
Eksperimentel: Base with glycerol beverage 1

No electrolytes, higher glycerol, lower volume
Andet: 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.
Eksperimentel: Base with glycerol beverage 2

No electrolytes, lower glycerol, mid-volume
Andet: 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.
Eksperimentel: Base with glycerol beverage 3

No electrolytes, higher glycerol, higher volume
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fluid balance
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urine mass
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Screening visit

Current status (e.g., contraception, regular periods or not, etc.)
Screening visit
Adverse Events
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

PepsiCo Global R&D

Efterforskere

  • Ledende efterforsker: Lindsay Baker, PhD, PepsiCo R&D/Gatorade and Sports Science Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. juli 2025

Primær færdiggørelse (Faktiske)

2. december 2025

Studieafslutning (Faktiske)

2. december 2025

Datoer for studieregistrering

Først indsendt

19. februar 2025

Først indsendt, der opfyldte QC-kriterier

28. februar 2025

Først opslået (Faktiske)

3. marts 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PEP-2420

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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