RESUMO
Purpose: An open-label, single-arm study was conducted to evaluate the effectiveness of porcine placental extract (PPE) ingestion to improve late-onset hypogonadism (LOH) syndrome symptoms. In addition, we reported the safety of continuous PPE ingestion in biochemistry tests.Materials and Methods: Test food containing PPE was given daily to healthy male subjects with an Aging Males’ Symptoms (AMS) score of ≥27, who were assessed as having LOH syndrome. AMS score, blood hormone level, and other parameters were measured before the start of PPE ingestion, Week 4, and Week 8. And adverse events that occurred during the ingestion period were accumulated.Results: Excluding one subject who withdrew from the study due to an adverse event unrelated to the test food, 14 subjects were included in the analysis. In terms of AMS score, no improvement was observed at Week 4, whereas a significant improvement was observed at Week 8. AMS scores were further categorized into three subscales (psychological, somatic, and sexual) and analyzed. The results showed a significant improvement from baseline in somatic scores at Week 8. Meanwhile, no significant change in sexual hormone levels was observed. At Week 8, improvements from baseline were observed in renal function and LDL cholesterol level. There were no adverse events related to the test food.Conclusion: The study demonstrated that 8-week PPE ingestion in middle-aged and elderly men can improve LOH syndrome symptoms while having little effect on sexual hormone secretion.