Tokyo, June 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062002) titled 'Effects of test food consumption on male menopause and sperm quality in healthy adults: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on June 22.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Toyo Sugar Refining Co., Ltd.

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

Objective: Narrative objectives1 - To verify the effects of test food consumption on sperm motility in healthy adults. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 8 weeks Test product: Product containing Administration: Consume one tablet three times daily (breakfast, lunch, and dinner, in total three tablets a day) with water. *If a take is missed, it should be consumed as soon as remembered. The daily take should be consumed within the same day and should not be carried over to the following day. Interventions/Control_2 - Duration: 8 weeks Test product: Product not containing Administration: Consume one tablet three times daily (breakfast, lunch, and dinner, in total three tablets a day) with water. *If a take is missed, it should be consumed as soon as remembered. The daily take should be consumed within the same day and should not be carried over to the following day.

Eligibility: Age-lower limit - 40 years-old

Gender - Male Key inclusion criteria - 1. Japanese

2. Men

3. Individuals aged 40 or more and less than 60

4. Healthy individuals

5. Individuals who are concerned about infertility

6. Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck Depression Inventory-II (BDI-II) at Scr

7. Individuals whose blood concentration of total testosterone is 250 ng/dL or more at Scr

8. Individuals whose blood concentration of free testosterone is 7.5 pg/mL or more at Scr

9. Individuals whose AMS score is between 27 and 49 at Scr

10. Individuals whose psychological factors of the AMS is bad at Scr Key exclusion criteria - 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are diagnosed with azoospermia

5. Individuals who are diagnosed with erectile dysfunction (ED)

6. Individuals undergoing treatment for ED

7. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

8. Individuals who are taking or using medications (including herbal medicines) or supplements

9. Individuals who are allergic to medications or foods related to the test product, particularly those allergic to citrus fruit

10. Individuals who regularly take long hot baths or use saunas

11. Individuals who are excessive exercising or training for diet

12. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles

13. Individuals who currently smoke or began smoking cessation within three months before providing informed consent

14. Individuals who habitually drink >= 60 g/day of alcohol

15. Individuals who are taking supplements containing zinc, folic acid, arginine, etc.

16. Individuals who are deemed unsuitable for participation in this study by the principal investigator Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 13 Day Date of IRB - 2026 Year 05 Month 13 Day Anticipated trial start date - 2026 Year 06 Month 22 Day Last follow-up date - 2026 Year 11 Month 02 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070948

Disclaimer: Curated by HT Syndication.