Tokyo, July 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058514) titled 'Effects of test food on conditioning in athletes: a single-group study' on July 19.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Taiyo Kagaku Co., Ltd
Condition:
Condition - Healthy athletes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluate the effects on physical and mental condition after consuming the test food in athletes.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consume the test food for a certain period of time.
Eligibility:
Age-lower limit - 15
years-old
Gender - Male and Female
Key inclusion criteria - 1.Healthy athletes who are aged between 15 and 30 years at the time of informed consent.
2.Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose, and made the written agreement.
Key exclusion criteria - Subjects --
1.who are judged by the principal investigator to be ineligible to participate in this study with regard to their health condition.
2.with current or history of serious illnesses.
3.judged by the principal investigator to be unsuitable for this study.
Target Size - 45
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 05 Month 26 Day
Date of IRB - 2025 Year 05 Month 28 Day
Anticipated trial start date - 2025 Year 07 Month 19 Day
Last follow-up date - 2026 Year 04 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066902
Disclaimer: Curated by HT Syndication.
