Healthy Adult MaleNEX/008624NCT07570238
Effect of Gum Acacia and Electrolytes on Hydration After an Exercise-indued Dehydration
A study testing Rehydration beverage in people with Healthy Adult Male, run by Nexira at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- Rehydration beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- May 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-25
- Regular physical training on a recreational level
- Resting pulse rate <100; resting blood pressure <140 mmHg/<100 mmHg
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Analyze & Realize GmbH
Berlin, 10369
Veronika Bobb, vbobb@a-r.com
About this study
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
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
- Being tested
- Rehydration beverage
- Keywords
- hydration, gum acacia, magnesium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehydration beverageDietary supplement
On site prepared beverage to replenish 125% of body water loss during the standardized exercise
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | Provided to the participants in a blinded manner Receives: Dietary Supplement: Rehydration beverage |
| Gum Acacia (InaveaTM pure acacia) 8gr/L | Experimental | Provided to the participants in a blinded manner Receives: Dietary Supplement: Rehydration beverage |
| Gum Acacia (InaveaTM pure acacia) 8gr/L + Sea electrolytes (SimagTM 15) 1.2gr/L | Experimental | Provided to the participants in a blinded manner Receives: Dietary Supplement: Rehydration beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid retention (%)
Percentage of fluid retained from start of rehydration phase (weight of beverage intake ; cumulative urine weight)
Measured: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Secondary outcomes (17)
Net fluid balance (ml)
Net fluid balance = cumulative beverage intake (mL) - cumulative urine volume (mL) - total body sweat loss during standardized exercise (mL)
Measured: 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)
Measured: 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
Measured: 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)
Impedancemetry ; Intracellular water (ICW) / Extracellular water (ECW)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Sodium, Potassium, Chloride, Magnesium, Calcium
Measured: 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
Measured: 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)
Measured: 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 (%)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nexira
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570238
- Sponsor's protocol ID
- FIB12
- Other IDs
- Eth-SB-26-023
- Acronym
- NEX/008624
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07570238
- Acronym / sponsor ID
- NEX/008624 / FIB12
- Conditions
- Healthy Adult Male
- Keywords
- hydration, gum acacia, magnesium
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- NexiraIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Dietary Supplement: Rehydration beverageProvided to the participants in a blinded manner |
| Gum Acacia (InaveaTM pure acacia) 8gr/L | Experimental | Dietary Supplement: Rehydration beverageProvided to the participants in a blinded manner |
| Gum Acacia (InaveaTM pure acacia) 8gr/L + Sea electrolytes (SimagTM 15) 1.2gr/L | Experimental | Dietary Supplement: Rehydration beverageProvided to the participants in a blinded manner |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18-25
- Regular physical training on a recreational level
- Resting pulse rate <100; resting blood pressure <140 mmHg/<100 mmHg
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehydration beverageOn site prepared beverage to replenish 125% of body water loss during the standardized exercise | Dietary supplement | Gum Acacia (InaveaTM pure acacia) 8gr/L, Gum Acacia (InaveaTM pure acacia) 8gr/L + Sea electrolytes (SimagTM 15) 1.2gr/L, Water |
Primary outcome
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)
17 secondary outcomes
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
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
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
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
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
Global evaluation of tolerability (4 scales ; very good to poor)
Time frame: At 240 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehydration beverage in people with Healthy Adult Male, run by Nexira at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien Guillemet, MSc (+33682422169, d.guillemet@nexira.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid retention (%) (time frame: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.