Effect of Gum Acacia and Electrolytes on Hydration After an Exercise-indued Dehydration (NEX/008624)
11 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
24
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Damien Guillemet, MSc
- Telefoonnummer: +33682422169
- E-mail: d.guillemet@nexira.com
Studie Locaties
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Berlin, Duitsland, 10369
- analyze & realize GmbH
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Contact:
- Veronika Bobb
- E-mail: vbobb@a-r.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Water
Provided to the participants in a blinded manner
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On site prepared beverage to replenish 125% of body water loss during the standardized exercise
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Experimenteel: Gum Acacia (InaveaTM pure acacia) 8gr/L
Provided to the participants in a blinded manner
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On site prepared beverage to replenish 125% of body water loss during the standardized exercise
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Experimenteel: Gum Acacia (InaveaTM pure acacia) 8gr/L + Sea electrolytes (SimagTM 15) 1.2gr/L
Provided to the participants in a blinded manner
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On site prepared beverage to replenish 125% of body water loss during the standardized exercise
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Fluid retention (%)
Tijdsspanne: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Percentage of fluid retained from start of rehydration phase (weight of beverage intake ; cumulative urine weight)
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At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Net fluid balance (ml)
Tijdsspanne: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Net fluid balance = cumulative beverage intake (mL) - cumulative urine volume (mL) - total body sweat loss during standardized exercise (mL)
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Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Beverage Hydration Index (BHI)
Tijdsspanne: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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BHI = cumulative urine after intake of the verum beverage / cumulative urine after intake of the placebo (water)
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At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Bioelectrical impedance vector analysis (BIVA, L)
Tijdsspanne: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Impedancemetry ; Total body water, Extracellular water (ECW), Intracellular water (ICW), Ratio for ICW/ECW
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At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Urine osmolality (mosmol/kg)
Tijdsspanne: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Urine Specific Gravity (USG)
Tijdsspanne: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Urine volume (mL)
Tijdsspanne: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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(calculated from urine weight and USG)
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Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Blood Haemoglobin (g/dL)
Tijdsspanne: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Blood Haematocrit (%)
Tijdsspanne: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Plasma volume (%)
Tijdsspanne: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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calculated from Hemoglobin (g/dL) and Hematocrit (%) according to Dill and Costill 1974
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Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Change in body weight (kg)
Tijdsspanne: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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from the end of standardized exercise
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At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Body mass restored (%)
Tijdsspanne: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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from start of standardized exercise
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At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Thirst perception (VAS)
Tijdsspanne: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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100mm scale
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Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Gastro-Intetsainl symptoms (VAS)
Tijdsspanne: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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100mm scale ; Nausea, Cramps, Bloating, Borborygmi, Flatus
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Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Global evaluation of tolerability (4 scales ; very good to poor)
Tijdsspanne: At 240 minutes
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From participant, from investigator
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At 240 minutes
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Bioelectrical impedance vector analysis ratio (ICW/ECW)
Tijdsspanne: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Impedancemetry ; Intracellular water (ICW) / Extracellular water (ECW)
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At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Electrolytes in urine (mmol/L)
Tijdsspanne: At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Sodium, Potassium, Chloride, Magnesium, Calcium
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At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Electrolytes in blood (mmol/L)
Tijdsspanne: Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Sodium, Potassium, Chloride, Magnesium, Calcium
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Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 mei 2026
Primaire voltooiing (Geschat)
1 augustus 2026
Studie voltooiing (Geschat)
1 augustus 2026
Studieregistratiedata
Eerst ingediend
29 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2026
Eerst geplaatst (Werkelijk)
6 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
14 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
11 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- FIB12
- Eth-SB-26-023 (Andere identificatie: Ethik-Kommission der Ärztekammer Berlin (Germany))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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