Introduction: LN18178 is a standardized, synergistic combination of Punica granatum fruit rind and Theobroma cacao seed extracts, which has been reported to increase serum testosterone levels in young and aging males. Methods: The present 84-day randomized, double-blind, placebo-controlled study assessed the efficacy of LN18178 on the sexual function of aging male volunteers (age: 40-70 years; serum total testosterone: ≥ 300 ng/dL). The subjects with mild to moderate erectile dysfunction [5-item version of the International Index of Erectile Function (IIEF-5) scores 17-25] and low sexual desire (score < 3 on items 11 and 12 of IIEF) participated in this investigation. One hundred and twenty men were randomly allocated into either the LN18178 or placebo group (n=60); they took either 400 mg of LN18178 or a matched placebo capsule daily with breakfast. Results: Post-trial, the LN18178-supplemented participants reported significant (P < 0.05) improvements in total and domain scores of the Derogatis Interview for Sexual Functioning-Self Reporting Male (DISF-SR-M) questionnaire, as well as substantial improvements in IIEF-5 (International Index of Erectile Function-5) and erection hardness scores (EHS). Comparative analysis also revealed significant improvements in the multi-dimensional fatigue inventory (MFI) and general health survey (GHS) scores. LN18178 supplementation substantially (P < 0.05) increased the six-minute walk distance and hand-grip strength compared to placebo. The participants' hemato-biochemical parameters, urinalysis, and vitals were within the normal range. Conclusion: LN18178 enhances sexual function, libido and improves psychological well-being, as well as neuromotor function and general well-being in aging males. LN18178 supplementation is safe and well tolerated by the participants.
Keywords: Comprehensive safety; Derogatis Interview for Sexual Functioning-Male (DISF-SR-M); International Index of Erectile Function (IIEF); Punica granatum; Testosterone; Theobroma cacao.
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