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| ID | Type | Description | Link |
|---|---|---|---|
| Eth-SB-26-023 | Other Identifier | Ethik-Kommission der Ärztekammer Berlin (Germany) |
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| Name | Class |
|---|---|
| Analyze & Realize | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water | Placebo Comparator | Provided to the participants in a blinded manner |
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| Gum Acacia (InaveaTM pure acacia) 8gr/L | Experimental | Provided to the participants in a blinded manner |
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| Gum Acacia (InaveaTM pure acacia) 8gr/L + Sea electrolytes (SimagTM 15) 1.2gr/L | Experimental | Provided to the participants in a blinded manner |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehydration beverage | Dietary Supplement | On site prepared beverage to replenish 125% of body water loss during the standardized exercise |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Damien Guillemet, MSc | Contact | +33682422169 | d.guillemet@nexira.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Analyze & Realize GmbH | Berlin | 10369 | Germany |
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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.
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Sponsor and Biostatistician
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |