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Effetti del volume delle bevande, concentrazione di glicerolo e concentrazione di sodio sull'equilibrio dei fluidi negli uomini e nelle donne sani euidratati a riposo

16 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo beverage

Base beverage, no electrolytes, no glycerol
Altro: 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
Sperimentale: Electrolyte solution without glycerol beverage 1

Higher electrolytes lower volume
Altro: 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.
Sperimentale: Electrolyte solution without glycerol beverage 2

Lower electrolytes mid-volume
Altro: 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.
Sperimentale: Electrolyte solution without glycerol beverage 3

Higher electrolytes higher volume
Altro: 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.
Sperimentale: Electrolyte solution with glycerol beverage 1

Lower electrolytes, lower glycerol, lower volume
Altro: 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.
Sperimentale: Electrolyte solution with glycerol beverage 2

Higher electrolytes, higher glycerol, lower volume
Altro: 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.
Sperimentale: Electrolyte solution with glycerol beverage 3

Higher electrolytes, higher glycerol, higher volume
Altro: 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.
Sperimentale: Base with glycerol beverage 1

No electrolytes, higher glycerol, lower volume
Altro: 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.
Sperimentale: Base with glycerol beverage 2

No electrolytes, lower glycerol, mid-volume
Altro: 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.
Sperimentale: Base with glycerol beverage 3

No electrolytes, higher glycerol, higher volume
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fluid balance
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Urine mass
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Screening visit

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

PepsiCo Global R&D

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 luglio 2025

Completamento primario (Effettivo)

2 dicembre 2025

Completamento dello studio (Effettivo)

2 dicembre 2025

Date di iscrizione allo studio

Primo inviato

19 febbraio 2025

Primo inviato che soddisfa i criteri di controllo qualità

28 febbraio 2025

Primo Inserito (Effettivo)

3 marzo 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PEP-2420

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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