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Not yet recruiting NCT07570238

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

No phase Interventional Healthy Adult Male

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rehydration beverage.
Who it may be relevant to
Registry conditions: Healthy Adult Male. Basic parameters: 18 years — 40 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • Fluid retention (%) [Time frame: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes]
Secondary outcome measures (12)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

Germany · 1 center
  • Analyze & Realize GmbH — Berlin

Identifiers

NCT: NCT07570238 · FIB12 · Eth-SB-26-023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗