Seaberry ursolic acid improves daytime frequency and urgency of urination in healthy Japanese subjects: A randomized, placebo-controlled, double-blind trial
DOI:
https://doi.org/10.31989/ffhd.v15i6.1631Abstract
Background and objective: The fruit of seaberry (Hippophae rhamnoides), which exerts anti-hypertensive, hypoglycemic, anti-obesity, and immunomodulatory effects, contains triterpenoids, namely ursolic acid. We previously reported that seaberry-derived ursolic acid suppressed urination frequency and anxiety related to urination in Japanese subjects; however, some subjects were patients with mild overactive bladder (OAB). Therefore, we conducted a clinical trial on the effects of ursolic acid supplementation on urination frequency and urination scores in healthy Japanese subjects.
Methods: Eighty out of 256 registered volunteers were enrolled in the present study. This was a randomized, placebo-controlled, double-blind study. All subjects were randomly allocated by the stratified block randomization method into the ursolic acid group (n=40) or placebo group (n=40). Tablets containing ursolic acid (0.2 mg/day) or placebo were administered for 8 weeks between January and March 2024. A voiding diary and the core lower urinary tract symptom score (CLSS) were the primary outcomes. The secondary outcomes were the OAB and King’s Health Questionnaire (KHQ). A safety analysis measured blood, urine, and other body parameters.
Results: The per-protocol set comprised 35 subjects in the ursolic acid group and 32 in the placebo group. Daytime urination frequency significantly decreased after 3 weeks of ursolic acid supplementation, and a significant correlation between the number of daytime urinations and time was detected in the ursolic acid group. No significant differences were observed in other scores or parameters in the safety analysis.
Conclusions: The intake of ursolic acid (0.2 mg/day) reduced daytime urination frequency and urgency. Therefore, seaberry ursolic acid can potentially manage urgent urination in healthy subjects.
Novelty: This study presents the novel finding that a low-dose (0.2 mg/day) ursolic acid supplementation derived from seaberry significantly reduces daytime urination frequency after 3 weeks and the urgency of urination in a randomized, placebo-controlled, double-blind clinical trial conducted explicitly on healthy Japanese adults.
Trial Registration: UMIN-CTR: UMIN000052848
Foundation: Oryza Oil & Fat Chemical Co., Ltd.
Keywords: ursolic acid; seaberry; urination; overactive bladder; core lower urinary tract symptom score; King’s health questionnaire; bioactive compounds
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