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A Clinical Study for Evaluating the Safety of Excessive Consumption of Saw Palmetto Extract
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JPY
Abstract
Aims To conduct an uncontrolled open-label study on healthy subjects to evaluate the safety of excessive consumption of saw palmetto oil at five times the recommended daily limit. Methods Five capsules containing 400 mg saw palmetto oil per capsule were consumed every day for 4 weeks by 22 subjects (11 males and 11 females; age 26-63 years), followed by observations for body weight, BMI, blood pressure╱pulse, clinical examination, and adverse events. Results No significant changes were observed in the body weight and BMI in comparison with the pre-test values among the subjects. However, significant changes were observed for several specific tests within the clinical examinations, including hematology, blood biochemistry, endocrine, and urine test in comparison with the pre-test values, although no changes were considered to be clinically problematic from both clinical and physical examinations as well as no side-effects were observed. Conclusion The safety of excessive consumption of the experimental food was confirmed in this study, as it was observed to induce no side︱effects as well as any other events considered to be problematic in safety evaluation.( UMIN 000033538)
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