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NCT Number: NCT07570238

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

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Key information

Conditions

Healthy Adult Male

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Analyze & Realize GmbH

Berlin, 10369, Germany

Location contact

Veronika Bobb

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehydration beverage

Dietary Supplement

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

Primary outcomes

  1. Fluid retention (%)

    Time frame: 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)

Secondary outcomes

  1. Net fluid balance (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

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

  2. Beverage Hydration Index (BHI)

    Time frame: 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)

  3. Bioelectrical impedance vector analysis (BIVA, L)

    Time frame: 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

  4. Bioelectrical impedance vector analysis ratio (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

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

  5. Urine osmolality (mosmol/kg)

    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

  6. Urine Specific Gravity (USG)

    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

  7. Urine volume (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

    (calculated from urine weight and USG)

  8. Electrolytes in urine (mmol/L)

    Time frame: 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

  9. Electrolytes in blood (mmol/L)

    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

    Sodium, Potassium, Chloride, Magnesium, Calcium

  10. Blood Haemoglobin (g/dL)

    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

  11. Blood Haematocrit (%)

    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

  12. Plasma volume (%)

    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

    calculated from Hemoglobin (g/dL) and Hematocrit (%) according to Dill and Costill 1974

  13. Change in body weight (kg)

    Time frame: 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

  14. Body mass restored (%)

    Time frame: 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

  15. Thirst perception (VAS)

    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

    100mm scale

  16. Gastro-Intetsainl symptoms (VAS)

    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

    100mm scale ; Nausea, Cramps, Bloating, Borborygmi, Flatus

  17. Global evaluation of tolerability (4 scales ; very good to poor)

    Time frame: At 240 minutes

    From participant, from investigator

Study contacts

Contact information is provided by the study sponsor or research team.

Damien Guillemet, MSc

CONTACT

[email protected]

+33682422169

Sponsors and collaborators

Lead sponsor

Nexira

Industry

Collaborators

  • Analyze & Realize

Registry information

Official study title

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

Acronym: NEX/008624

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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