Healthy Adult Male
Conditions
Keywords
hydration, gum acacia, magnesium
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.
Interventions
DIETARY_SUPPLEMENTRehydration beverage
On site prepared beverage to replenish 125% of body water loss during the standardized exercise
Sponsors
Nexira
Analyze & Realize
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Sponsor and Biostatistician
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluid retention (%) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Net fluid balance = cumulative beverage intake (mL) - cumulative urine volume (mL) - total body sweat loss during standardized exercise (mL) |
| Beverage Hydration Index (BHI) | 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) |
| 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 | Impedancemetry ; Total body water, Extracellular water (ECW), Intracellular water (ICW), Ratio for ICW/ECW |
| Bioelectrical impedance vector analysis ratio (ICW/ECW) | 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) |
| 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) | 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) |
| Electrolytes in urine (mmol/L) | 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 |
| Electrolytes in blood (mmol/L) | 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 |
| 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 (%) | 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 |
| Change in body weight (kg) | 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 |
| Body mass restored (%) | 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 |
| Thirst perception (VAS) | 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 |
| Gastro-Intetsainl symptoms (VAS) | 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 |
| Global evaluation of tolerability (4 scales ; very good to poor) | At 240 minutes | From participant, from investigator |
Countries
Germany
Contacts
CONTACTDamien Guillemet, MSc
Outcome results
None listed