Effect of Gum Acacia and Electrolytes on Hydration After an Exercise-indued Dehydration (NEX/008624)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Male
• Intervention / Treatment: Dietary supplement: Rehydration beverage

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damien Guillemet, MSc; Phone Number: +33682422169; Email: d.guillemet@nexira.com

Study Locations

• Germany
  • Berlin, Germany, 10369
    • Analyze & Realize GmbH
    • Contact: Veronika Bobb; Email: vbobb@a-r.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Water; Provided to the participants in a blinded manner	Dietary supplement: Rehydration beverage; On site prepared beverage to replenish 125% of body water loss during the standardized exercise
Experimental: Gum Acacia (InaveaTM pure acacia) 8gr/L; Provided to the participants in a blinded manner	Dietary supplement: Rehydration beverage; On site prepared beverage to replenish 125% of body water loss during the standardized exercise
Experimental: Gum Acacia (InaveaTM pure acacia) 8gr/L + Sea electrolytes (SimagTM 15) 1.2gr/L; Provided to the participants in a blinded manner	Dietary supplement: Rehydration beverage; On site prepared beverage to replenish 125% of body water loss during the standardized exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net fluid balance (ml)	Net fluid balance = cumulative beverage intake (mL) - cumulative urine volume (mL) - total body sweat loss during standardized exercise (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)	BHI = cumulative urine after intake of the verum beverage / cumulative urine after intake of the placebo (water)	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)	Impedancemetry ; Total body water, Extracellular water (ECW), Intracellular water (ICW), Ratio for ICW/ECW	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
Urine volume (mL)	(calculated from urine weight and 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
Blood Haemoglobin (g/dL)		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 (%)		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 (%)	calculated from Hemoglobin (g/dL) and Hematocrit (%) according to Dill and Costill 1974	Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Change in body weight (kg)	from the end of standardized exercise	At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Body mass restored (%)	from start of standardized exercise	At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Thirst perception (VAS)	100mm scale	Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Gastro-Intetsainl symptoms (VAS)	100mm scale ; Nausea, Cramps, Bloating, Borborygmi, Flatus	Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Global evaluation of tolerability (4 scales ; very good to poor)	From participant, from investigator	At 240 minutes
Bioelectrical impedance vector analysis ratio (ICW/ECW)	Impedancemetry ; Intracellular water (ICW) / Extracellular water (ECW)	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)	Sodium, Potassium, Chloride, Magnesium, Calcium	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)	Sodium, Potassium, Chloride, Magnesium, Calcium	Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes

Collaborators and Investigators

• Sponsor: Nexira
• Collaborators: Analyze & Realize

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: magnesium; gum acacia; hydration
• Other Study ID Numbers: FIB12; Eth-SB-26-023 (Other Identifier: Ethik-Kommission der Ärztekammer Berlin (Germany))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No