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Effect of Gum Acacia and Electrolytes on Hydration After an Exercise-indued Dehydration

ConditionHealthy Adult Male
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-40
SponsorNexira

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI 18-25

Regular physical training on a recreational level

Resting pulse rate <100; resting blood pressure <140 mmHg/<100 mmHg

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Rehydration beverage

    Dietary supplement

    On site prepared beverage to replenish 125% of body water loss during the standardized exercise

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: WaterPlacebo comparator 1 intervention
Group B: Gum Acacia (InaveaTM pure acacia) 8gr/LExperimental treatment 1 intervention
Group C: Gum Acacia (InaveaTM pure acacia) 8gr/L + Sea electrolytes (SimagTM 15) 1.2gr/LExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Fluid retention (%)

Percentage of fluid retained from start of rehydration phase (weight of beverage intake ; cumulative urine weight)

Time frame
At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes

Secondary outcomes

1

Net fluid balance (ml)

Net fluid balance = cumulative beverage intake (mL) - cumulative urine volume (mL) - total body sweat loss during standardized exercise (mL)

Time frame
Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
2

Beverage Hydration Index (BHI)

BHI = cumulative urine after intake of the verum beverage / cumulative urine after intake of the placebo (water)

Time frame
At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
3

Bioelectrical impedance vector analysis (BIVA, L)

Impedancemetry ; Total body water, Extracellular water (ECW), Intracellular water (ICW), Ratio for ICW/ECW

Time frame
At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
4

Bioelectrical impedance vector analysis ratio (ICW/ECW)

Impedancemetry ; Intracellular water (ICW) / Extracellular water (ECW)

Time frame
At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nexira

Lead sponsor

Analyze & Realize

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: