薬理と治療

Abstract

Objective　This study aimed to evaluate the efficacy of Every Support–ORS plus(EORS+)on the absorption and excretion of water and electrolytes in a human dehydration model induced by heat stress in a sauna. Methods　A randomized, open label, two–period crossover comparative trial was conducted involving healthy male participants subjected to heat–stress–induced dehydration via sauna use. Participants consumed either EORS+ or placebo in an amount equivalent to their estimated water loss, as calculated from weight reduction after sauna stress. The primary endpoint was the change in body weight observed over 4 hours post–ingestion. Secondary endpoints included blood and urinary biomarkers, as well as other symptoms, monitored over the same 4–hours period. Results　Twenty–two healthy male participants were enrolled in this study. After 4 hours, the reduction in body weight was 0.45 kg following ingestion of EORS+, compared to 0.61 kg with mineral water(MW), resulting in a between–group difference of 0.14 kg(95% CI　0.06–0.21, P=0.001). Additionally, EORS+ was associated with higher levels of serum sodium(Difference 　1.21 mEq/L, 95% CI　0.73–1.70, P<0.001), chloride(Difference　1.16 mEq/L, 95% CI 0.57–1.74, P<0.001), osmotic pressure(Difference　1.39 mOsm/kg, 95% CI　0.29–2.48, P=0.014), and water balance(Difference　87.72 g, 95% CI　2.53–172.91, P=0.044)at 4 hours post–ingestion. Furthermore, participants who consumed EORS+ demonstrated an earlier recovery in blood biomarkers following sauna–induced dehydration. Scores for subjective symptoms did not differ significantly between the groups. No adverse events related to the test solution were reported in this trial. Conclusions　The findings suggest that EORS+ facilitates early recovery from dehydration induced by sauna–related heat stress in healthy adults by supporting efficient rehydration and electrolyte replenishment.(UMIN ID: UMIN000054399)(Jpn Pharmacol Ther 2025;53:473‒88)