Tokyo, July 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058479) titled 'Evaluation of the effect of ingesting test food on reducing heat stress' on July 15.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Karada Lab, Inc. (Arkray Group)
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluating the effect of ingesting the test food for 15 to 20 days on heat stress indexes
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ingesting the test food for 15 to 20 days, followed by a washout period and then the placebo food for 15 to 20 days.
Interventions/Control_2 - Ingesting the placebo food for 15 to 20 days, followed by a washout period and then the test food for 15 to 20 days.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - 1) Men aged 20 to 65 at the time of obtaining consent
2) Participants who are exposed to heat stress in their daily work
Key exclusion criteria - 1) Participants who have abnormalities in their regular health checkup results and are deemed unsuitable for participation in the study
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 27 Day
Date of IRB - 2025 Year 07 Month 15 Day
Anticipated trial start date - 2025 Year 07 Month 16 Day
Last follow-up date - 2025 Year 09 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066848
Disclaimer: Curated by HT Syndication.
