Tokyo, Nov. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059136) titled 'Exploratory study on the effects of verbal encouragement on endogenous biomarkers in healthy adult males' on Nov. 22.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - HUMA R&D CORP
Condition:
Condition - Healthy individuals
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To explore the effects of verbal encouragement on endogenous biomarkers in healthy adult males
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Presence of verbal encouragement - Washout - Absence of verbal encouragement
Interventions/Control_2 - Abesence of verbal encouragement - Washout - Presence of verbal encouragement
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Male
Key inclusion criteria - 1) Individuals who have given written consent to participate in this study
2) Males aged 30 to 59 when obtaining the consent
3) Individuals who are able to undergo preliminary/follow-up examinations, cognitive test, consume the prescribed food, answer the various questionnaire, have blood draws and stool collections, and skin gas collection according to the schedule requested by the research personnel
4) Individuals who scored between 30 and less than 70 in the standardized score of the behavioral temperament test during preliminary examination
Key exclusion criteria - 1) Individuals who were deemed ineligible for this study by the principal investigator based on the results of the preliminary examination
2) Individuals with visual, auditory, or motor impairments that interfere with the administration of cognitive function tests
3) Individuals who currently have or previously had gastrointestinal, cardiovascular, endocrine, inflammatory (immunological), neuropsychiatry, or other diseases; individuals who regularly use drugs to treat diseases and are considered unsuitable to participate in this study by the principal investigator; individuals on antibiotics, anti-inflammatory drugs, anti-allergic drugs, steroids, immunosuppressants, etc.; and individuals with a common cold
4) Individuals with smoking habits
5) Individuals who intend to stay abroad overnight between the prescreening and follow-up examinations
6) Individuals with food allergy
7) Individuals who donated blood within 12 weeks prior to the prescreening examination
8) Individuals who are currently participating in another study or are scheduled to participate in one during the study period
9) Individuals who are estimated inappropriate to this study by principal investigator or study director
Target Size - 24
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 09 Month 05 Day
Date of IRB - 2025 Year 09 Month 12 Day
Anticipated trial start date - 2025 Year 09 Month 22 Day
Last follow-up date - 2025 Year 11 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067643
Disclaimer: Curated by HT Syndication.
