Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063175) titled 'A prospective single-arm pilot study to evaluate the effects of test food intake on semen parameters and to assess safety in healthy adult males' on Oct. 6.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - DAIZUMOTO CLINIC

Condition: Condition - Healthy volunteer Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study will evaluate, in an exploratory manner, the effects of test food intake on sperm motility, basic semen parameters, sperm DNA fragmentation, oxidative stress markers, and blood concentrations of sex hormones in adult males. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will take 3 tablets of the test food once daily after breakfast for 8 weeks with water or lukewarm water.

Eligibility: Age-lower limit - 20 years-old = Gender - Male Key inclusion criteria - 1. Male individuals aged 20 years or older and 50 years or younger at the time of informed consent 2. Individuals who have received sufficient explanation about the purpose and content of this study, understood the explanation, and voluntarily provided written informed consent Key exclusion criteria - 1. Individuals with azoospermia or a sperm motility rate of 0% (complete asthenozoospermia) 2. Individuals with leukocytospermia (defined as 1x10^6 or more leukocytes per mL of semen) or active genitourinary infection 3. Individuals with serious hepatic, renal, cardiac, endocrine, or metabolic disease 4. Individuals with a risk of allergic symptoms related to silkworm (silk), mushrooms, other foods, or drugs 5. Individuals who have continuously used supplements that may affect spermatogenesis (e.g., CoQ10, vitamins, maca, zinc, ginseng, or Cordyceps), Kampo medicines, or hormonal agents within the past 4 weeks 6. Individuals who are currently participating in another clinical trial or have participated in another clinical trial within the past 3 months 7. Individuals who are judged by the principal investigator to be unsuitable for participation in this study Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 06 Day Date of IRB - 2026 Year 08 Month 27 Day Anticipated trial start date - 2026 Year 10 Month 06 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072301

Disclaimer: Curated by HT Syndication.