Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062740) titled 'Mental fatigue stress test following ingestion of inositol-containing tablets' on Aug. 31.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Tsuno Rice Fine Chemicals Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate differences in feelings of fatigue among healthy subjects when performing a task after taking inositol or a placebo tablet.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Take one tablet containing 500 mg of inositol derived from rice bran
Interventions/Control_2 - Take one tablet containing starch hydrolysate
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Healthy individuals in their 20s through 40s.
2. Healthy individuals with no chronic physical illnesses, as confirmed through a medical interview.
3. Individuals who have not consumed any food products with fatigue-recovery effects.
4. Individuals who have received a thorough explanation of the purpose and content of this trial, possess the capacity to give informed consent, have volunteered to participate after fully understanding the details, and are able to provide written consent to participate in this trial.
5. Individuals who are able to come to the facility on the designated test date and undergo the examination.
6. Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria - 1. Individuals currently suffering from any medical condition and undergoing drug treatment.
2. Individuals with severe symptoms caused by a medical condition, such as motor or respiratory disorders.
3. Individuals who are unable to refrain from taking over-the-counter supplements containing inositol during the study period.
4. Individuals with allergies (to medications or products related to the study materials).
5. Individuals who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
6. Individuals who are currently taking, or have taken within the past month, medications advertised to alleviate mental fatigue.
7. Individuals taking potent medications (as determined by the principal investigator).
8. Any other individuals whom the principal investigator deems unsuitable for participation in this trial.
Target Size - 16
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 25 Day
Date of IRB - 2026 Year 08 Month 25 Day
Anticipated trial start date - 2026 Year 08 Month 31 Day
Last follow-up date - 2026 Year 09 Month 11 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071792
Disclaimer: Curated by HT Syndication.
