Tokyo, Nov. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063593) titled 'Effects of Continuous Intake of Inositol-Containing Tablets on Mental Fatigue: A Randomized, double-blind, placebo-controlled, crossover trial' on Nov. 15.

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 - This study involves healthy participants who continuously take either inositol-containing tablets or placebo tablets, and evaluates differences in feelings of mental fatigue when subjected to a mental fatigue stressor. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Take one tablet containing 500 mg of rice bran-derived inositol once a day for one week. Interventions/Control_2 - Take one tablet containing starch hydrolysate once a day for one week.

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 11 Month 10 Day Date of IRB - 2026 Year 11 Month 10 Day Anticipated trial start date - 2026 Year 11 Month 16 Day Last follow-up date - 2026 Year 12 Month 11 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072766

Disclaimer: Curated by HT Syndication.