Healthy individuals
Conditions
Interventions
Presence of verbal encouragement - Washout - Absence of verbal encouragement
Abesence of verbal encouragement - Washout - Presence of verbal encouragement
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Primary Outcome Measures Changes in the following omics profiles based on the presence or absence of verbal encouragement (VE): - Blood: Proteome, metabolome, microRNA, synchrotron radiation-based particle and elemental analysis - Feces: Microbiome - Skin: Gas component profile 2) Safety Evaluation Frequency of adverse events occurring during the verbal encouragement (VE) intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Secondary Outcome Measures Changes in psychological questionnaire scores based on the presence or absence of verbal encouragement (VE): - PANAS, POMS2, SHS, GSES, FRS, Mind-body questionnaire 2) Exploratory Outcome Measures Changes in cognitive function based on the presence or absence of verbal encouragement (VE) | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed