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Effect of Gum Acacia and Electrolytes on Hydration After an Exercise-indued Dehydration (NEX/008624)

11 maggio 2026 aggiornato da: Nexira

A Single-blinded, Placebo-controlled, Three-way Crossover Pilot Study, to Assess the Rehydrating Effect of a Nutritional Preparation Containing Gum Acacia Combined With Sea Magnesium After Exercise-induced Dehydration

This clinical study is a single-blind, placebo-controlled, three-way cross-over trial evaluating the rehydration efficacy of two nutritional beverages compared to water, after one administration. The investigational products are gum acacia alone, and combined with sea electrolytes as magnesium. Participants, physically active men undergo exercise-induced dehydration followed by controlled rehydration procedure with each product in randomized sequence. The study includes standardized preconditions (diet, hydration, activity control), exercise and rehydration protocols.

Gam acacia has the benefit of few preclinic studies in murin models showing significant improvements on electrolytes and water absorption, but its effect on hydration in human has never been evaluated.

The combination with sea electrolytes has been developed to optimise and reduce the total concentration of electrolytes into the beverage compared to standard formulations proposed for rehydration in sport application.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

24

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.

Contatto studio

Luoghi di studio

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

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • BMI 18-25
  • Regular physical training on a recreational level
  • Resting pulse rate <100; resting blood pressure <140 mmHg/<100 mmHg

Exclusion Criteria:

  • Participant suffering from acute or recently occurred (in the past 2 weeks) sickness e.g. common cold or gastrointestinal problems
  • Injuries that would limit exercise performance
  • History or presence of cardiovascular, metabolic, endocrine musculoskeletal, autoimmune or renal condition/disorder which per investigator's judgement could interfere with the results of the study or the safety of the participant

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: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Water
Provided to the participants in a blinded manner
Integratore alimentare: Rehydration beverage
On site prepared beverage to replenish 125% of body water loss during the standardized exercise
Sperimentale: Gum Acacia (InaveaTM pure acacia) 8gr/L
Provided to the participants in a blinded manner
Integratore alimentare: Rehydration beverage
On site prepared beverage to replenish 125% of body water loss during the standardized exercise
Sperimentale: Gum Acacia (InaveaTM pure acacia) 8gr/L + Sea electrolytes (SimagTM 15) 1.2gr/L
Provided to the participants in a blinded manner
Integratore alimentare: Rehydration beverage
On site prepared beverage to replenish 125% of body water loss during the standardized exercise

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fluid retention (%)
Lasso di tempo: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Percentage of fluid retained from start of rehydration phase (weight of beverage intake ; cumulative urine weight)
At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Net fluid balance (ml)
Lasso di tempo: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Net fluid balance = cumulative beverage intake (mL) - cumulative urine volume (mL) - total body sweat loss during standardized exercise (mL)
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Beverage Hydration Index (BHI)
Lasso di tempo: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
BHI = cumulative urine after intake of the verum beverage / cumulative urine after intake of the placebo (water)
At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Bioelectrical impedance vector analysis (BIVA, L)
Lasso di tempo: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Impedancemetry ; Total body water, Extracellular water (ECW), Intracellular water (ICW), Ratio for ICW/ECW
At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Urine osmolality (mosmol/kg)
Lasso di tempo: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Urine Specific Gravity (USG)
Lasso di tempo: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Urine volume (mL)
Lasso di tempo: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
(calculated from urine weight and USG)
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Blood Haemoglobin (g/dL)
Lasso di tempo: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Blood Haematocrit (%)
Lasso di tempo: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Plasma volume (%)
Lasso di tempo: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
calculated from Hemoglobin (g/dL) and Hematocrit (%) according to Dill and Costill 1974
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Change in body weight (kg)
Lasso di tempo: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
from the end of standardized exercise
At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Body mass restored (%)
Lasso di tempo: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
from start of standardized exercise
At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Thirst perception (VAS)
Lasso di tempo: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
100mm scale
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Gastro-Intetsainl symptoms (VAS)
Lasso di tempo: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
100mm scale ; Nausea, Cramps, Bloating, Borborygmi, Flatus
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Global evaluation of tolerability (4 scales ; very good to poor)
Lasso di tempo: At 240 minutes
From participant, from investigator
At 240 minutes
Bioelectrical impedance vector analysis ratio (ICW/ECW)
Lasso di tempo: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Impedancemetry ; Intracellular water (ICW) / Extracellular water (ECW)
At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Electrolytes in urine (mmol/L)
Lasso di tempo: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Sodium, Potassium, Chloride, Magnesium, Calcium
At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Electrolytes in blood (mmol/L)
Lasso di tempo: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Sodium, Potassium, Chloride, Magnesium, Calcium
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes

Collaboratori e investigatori

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

Sponsor

Nexira

Collaboratori

Analyze & Realize

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 (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 agosto 2026

Completamento dello studio (Stimato)

1 agosto 2026

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • FIB12
  • Eth-SB-26-023 (Altro identificatore: Ethik-Kommission der Ärztekammer Berlin (Germany))

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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