A study investigating the relationship between physical condition and the brain function in healthy adult males

Not Applicable

• Conditions: Healthy subjects

• Registration Number: JPRN-UMIN000042983
• Lead Sponsor: HUMA R&D CORP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-03-26
• Study Start: 2022-03-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1) Subject who has collected 200 mL or more of whole blood within 4 weeks, or 400 mL or more of whole blood within 12 weeks, prior to the first blood collection 2) Subject whose clinical laboratory test values deviate from the normal range and are judged by the principal investigator to be ineligible for this study 3) Subject with any medical history of brain, nerve, psychiatry, circulatory system, endocrine function, or color vision deficiency who is judged by the principal investigator to be ineligible for this study 4) Subject whose rise in sublingual temperature is 1 degree Celsius or more, or less than 0.1 degree Celsius during the thermal load performed at a screening test 5) Subject whose total number of correct answers in Kraepelin test conducted at the screening test exceeds the average value plus-minus 2SD 6) Subject who cannot drink the specified amount of the test food 7) Subject who has used health foods or drugs and the principal investigator has determined that the usage affect the evaluation of the outcomes 8) Subject who is estimated inappropriate to this study by principal investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(Evaluation items) Changes in the result of Uchida Kraepelin test, Stroop test, and Paced Auditory Serial Addition Test (PASAT); changes in body temperature; changes in cerebral blood flow; changes in the result of subjective evaluation questionnaire by Visual Analog Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
(Exploratory evaluation items) Heart rate and heart rate variability, blood glucose level, hematocrit level, and serum osmolality (Safety evaluation) Frequency of adverse events during the study, general physical findings, and vital signs