UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059726 |
|---|---|
| Receipt number | R000068267 |
| Scientific Title | Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled double-blind crossover study |
| Date of disclosure of the study information | 2026/11/11 |
| Last modified on | 2025/11/10 15:07:37 |
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Basic information
Public title
Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled double-blind crossover study
Acronym
Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled double-blind crossover study
Scientific Title
Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled double-blind crossover study
Scientific Title:Acronym
Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled double-blind crossover study
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the psychological impact of food ingredients in humans, the study on the subjective assessment of psychological impact and objective assessment to support the subjective assessment will be conducted.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological evaluation questionnaire
Key secondary outcomes
1. Physiological indicators that support psychology
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the placebo beverage twice daily (at the start of morning and afternoon work shifts) for 5 days.
Interventions/Control_2
Intake the test beverage twice daily (at the start of morning and afternoon work shifts) for 5 days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male
Key inclusion criteria
1. Aged 20 to under 45 at the time of informed consent.
2. Japanese male
3. BMI of less than 30.0 kg/m2
4. Those who does not smoke (who have not been smoking for the last year)
5. Users of an iPhone with iOS 16 or later, or an Android device with OS 10 or later
6.Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.
Key exclusion criteria
1. Subjects receiving any medication or Chinese medication (except drugs as needed).
2. Subjects with history or current diagnosis of serious heart, liver, kidney, or GI tract diseases.
3. Subjects unable to evaluate flavor/aroma due to pollinosis (spring/grass pollen) or allergic rhinitis (seasonal/perennial).
4. Subjects under doctor-supervised dietary or exercise therapy.
5. Subjects regularly using commercial drugs, quasi-drugs, food for specified health use, or food affecting ANS or sleep (eligible if usage can be stopped after IC and during study).
6. Subjects with incompatible anatomy/condition for heartbeat measurements (e.g., thick body hair, pacemaker).
7. Subjects whose smartwatch measurement may be impaired (e.g., dense body hair on wrist).
8. Subjects who rash from chest electrodes or wrist smartwatch measurement.
9. Subjects with excessive alcohol intake (alcohol equivalent 60 g/day or more)
10. Subjects with excessive caffeine intake (400 mg/day or more).
11. Subjects with significantly irregular eating habits/lifestyles (e.g., shift/night workers).
12. Subjects who participated in another clinical study (other than ASAHI psych eval) within 1 month prior to IC, or who are currently/will be participating during study or within 4 weeks after end.
13. Subjects who experienced significant life stress (e.g., moving, job change, separation) within 3 months prior to IC, or who will have such an event during the study.
14. Subjects unable to abstain from caffeine during the study period (on weekdays).
15. Subjects unable to abstain from alcohol consumption from the day prior to 1st test food intake until the final day of intake.
16. Subjects with drug and/or food allergies.
17. Subjects who are unemployed, cannot work remotely, or whose work environment/duties are unstable during the study.
18. Subjects considered ineligible by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Oikawa |
Organization
Comfo-Garden Clinic, Shokoukai
Division name
President
Zip code
162-0054
Address
3-2, Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
03-3357-0086
comfo-rinshou@synaps.co.jp
Public contact
Name of contact person
| 1st name | Natsu |
| Middle name | |
| Last name | Ikeyama |
Organization
Macromill, Inc.
Division name
Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
03-6716-0700
Homepage URL
ikeyama@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, Ltd
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Tsukiji Futaba Clinic.
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo, Japan
Tel
03-6226-5812
tohru@hikobae.net
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068267
