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

NCT07570238 | Not Yet Recruiting

• 2 other identifiers: FIB12Eth-SB-26-023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult Male

Keywords

hydration; gum acacia; magnesium

Outcome Measures

Primary Outcomes (1)

• Fluid retention (%)

  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

Secondary Outcomes (16)

• Net fluid balance (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)

  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)

  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)

  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)

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

Study Arms (3)

Water

PLACEBO COMPARATOR

Containing same quality and quantity of lemon flavor than other investigational products ; provided to the participants in a blinded manner

Dietary Supplement: Rehydration beverage

Gum Acacia 8gr/L

EXPERIMENTAL

Containing same quality and quantity of lemon flavor than other investigational products ; provided to the participants in a blinded manner

Dietary Supplement: Rehydration beverage

Gum Acacia 8gr/L + Sea electrolytes 1.2gr/L

EXPERIMENTAL

Containing same quality and quantity of lemon flavor than other investigational products ; provided to the participants in a blinded manner

Dietary Supplement: Rehydration beverage

Interventions

Rehydration beverage DIETARY_SUPPLEMENT

Quantity of beverage to replenish 125% of body water loss during the standardized exercise

Gum Acacia 8gr/L; Gum Acacia 8gr/L + Sea electrolytes 1.2gr/L; Water

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nexira: lead
• Analyze & Realize: collaborator

Study Sites (1)

Analyze & Realize GmbH

Berlin, 10369, Germany

Location

Central Study Contacts

Damien Guillemet, MSc

CONTACT

+33682422169; d.guillemet@nexira.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sponsor and Biostatistician
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Standardized exercise triggers a water loss through sweat which is calculated from body weight differences. The rehydration procedure investigating interventional products in beverage, follows the exercise and must replenish 125% of sweat losses.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)