Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059033) titled 'Effects of test food consumption on sperm motility in healthy adults' on Sept. 9.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
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: Four weeks
Consume one of the following test foods.
1. Flavonoid-containing food A
2. Flavonoid-containing food B
3. Flavonoid-containing food C
Eligibility:
Age-lower limit - 30
years-old
Gender - Male
Key inclusion criteria - 1. Japanese
2. Men
3. Individuals aged 30 or more and less than 60
4. Healthy individuals
5. Individuals who are concerned about infertility
Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
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 who are undergoing medical treatment for ED
7. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
8. Individuals who are taking or using medicines (including herbal medicines) or supplements
9. Individuals who are allergic to medicines or foods related to the test product, particularly to citrus fruits
10. Individuals who regularly take long hot baths or use saunas
11. Individuals who are excessive exercising or training for diet
12. Individuals who have irregular sleeping time or habit due to work such as a late-night shift or irregular lifestyles
Individuals who are smokers or have quit smoking within the last three months before the agreement to participate in this study
14. Individuals who usually drink more than 60 g/day of alcohol
15. Individuals who are taking supplements containing zinc, folic acid, arginine, etc.
16. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
17. Individuals who are judged as ineligible to participate in this study by the physician
Target Size - 30
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 06 Month 24 Day
Date of IRB - 2025 Year 06 Month 24 Day
Anticipated trial start date - 2025 Year 09 Month 09 Day
Last follow-up date - 2025 Year 12 Month 29 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067520
Disclaimer: Curated by HT Syndication.