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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
24
On site prepared beverage to replenish 125% of body water loss during the standardized exercise
Analyze & Realize GmbH
Berlin, Germany
Fluid retention (%)
Percentage of fluid retained from start of rehydration phase (weight of beverage intake ; cumulative urine weight)
Time frame: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Net fluid balance (ml)
Net fluid balance = cumulative beverage intake (mL) - cumulative urine volume (mL) - total body sweat loss during standardized exercise (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)
BHI = cumulative urine after intake of the verum beverage / cumulative urine after intake of the placebo (water)
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)
Impedancemetry ; Total body water, Extracellular water (ECW), Intracellular water (ICW), Ratio for 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
Bioelectrical impedance vector analysis ratio (ICW/ECW)
Impedancemetry ; Intracellular water (ICW) / Extracellular water (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)
(calculated from urine weight and 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
Electrolytes in urine (mmol/L)
Sodium, Potassium, Chloride, Magnesium, Calcium
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)
Sodium, Potassium, Chloride, Magnesium, Calcium
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 (%)
calculated from Hemoglobin (g/dL) and Hematocrit (%) according to Dill and Costill 1974
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)
from the end of standardized exercise
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 (%)
from start of standardized exercise
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)
100mm scale
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)
100mm scale ; Nausea, Cramps, Bloating, Borborygmi, Flatus
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)
From participant, from investigator
Time frame: At 240 minutes
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