Tokyo, May 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061645) titled 'Whether brain lactate, peripheral blood amino acids, and facial expression changes are involved in the decline of executive function induced by incremental exercise' on May 21.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Niigata University of Health and Welfare
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the nonlinear (U-shaped) relationship between lactate concentration changes in the dorsolateral prefrontal cortex (dlPFC) and executive function during incremental exercise, and to clarify whether these changes are associated with the plasma tryptophan/BCAA ratio and facial expression changes during exercise.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - ncremental exercise using a cycle ergometer. The workload is incremented by 15 W/min until the participant can no longer maintain the prescribed pedaling cadence (volitional exhaustion; typical duration 20 min). Heart rate and arterial oxygen saturation are continuously monitored during exercise, and a low-intensity cool down on the ergometer is performed immediately after.
Interventions/Control_2 - Seated rest on the cycle ergometer for 20 minutes. The same equipment, posture, and time frame as the exercise condition are maintained to control for the effects of time alone without exercise.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Healthy adults aged 18 to 30 years who are students enrolled at Niigata University of Health and Welfare and who provide written informed consent. Participants must have no respiratory abnormalities and no contraindications to MRI examination (e.g., metallic implants, cardiac pacemakers, claustrophobia).
Key exclusion criteria - Individuals with a history of cardiovascular disease, orthopedic conditions requiring exercise restriction, neurological disorders, or any serious internal medical condition currently under treatment; and those who have been advised by a physician to restrict physical exercise.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 21 Day
Anticipated trial start date - 2026 Year 05 Month 21 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070534
Disclaimer: Curated by HT Syndication.