UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055499 |
|---|---|
| Receipt number | R000063396 |
| Scientific Title | Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled single-blind crossover study |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2024/09/13 16:16:57 |
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Basic information
Public title
Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled single-blind crossover study
Acronym
Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled single-blind crossover study
Scientific Title
Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled single-blind crossover study
Scientific Title:Acronym
Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled single-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
2. Questionnaires
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo food AIX-1 will be ingested over a period of 15 minutes.
Interventions/Control_2
Study food AIX-2 will be ingested over a period of 15 minutes.
Interventions/Control_3
Study food AIX-3 will be ingested over a period of 15 minutes.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 20 to under 40 at the time of informed consent.
2. Japanese male and female
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. 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. Taking medication or Chinese medication (except for the dugs as needed)
2. Current of history of serious diseases such as heart, liver, kidney, gastrointestinal tract.
3. Those who has pollinosis (autumn pollen) or allergic rhinitis (seasonal/perennial)
4. Under diet of exercise therapy under the supervision of a doctor
5. Those who regularly uses any commercially available drug and quasi-drug, food for specified health use, food that affects autonomic nervous system, and sleep (however, the person will be eligible if he/she can stop using it during the study period after provision of the informed consent)
6. Subjects with incompatible chest (e.g., thick bodyhair, pacemaker-fitting) for heartbeat measurements.
7. Subjects who break out in a rash from putting electrodes on the chest.
8. Excessive consumption of alcohol (alcohol equivalent 60g or more /day)
9. Irregular diet, shift worker, night shift, irregular life rhythm
10. Those who has participated another clinical study within 1 month prior to provision of the informed consent , other than the psychological evaluation study conducted by ASAHI,or is currently participating in it, or will participate in it during the study period or within 4 weeks after the end of the study
11. Those who will be possibly under significant stress of any life event such as moving, changing his/her job, and separation from a close relative, within 3 months prior to provision of the informed consent, or will have such a life event during the study period
12. Those who has difficulty abstaining from alcohol staring from one day prior to the start of the study
13. Current of history of drug and/or food allergies
14. Those who is unable to drink alcohol constitutionally
15. Those who is in pregnancy or nursing
16. Judged by the investigator to be unsuitable for participating in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Higashi Koganei Sakura Clinic
Division name
Director
Zip code
184-0011
Address
4-37-26, Higashicho, Koganei-shi, Tokyo, Japan
TEL
042-382-3888
clinical-trial@imeqrd.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
070-2488-5464
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-3207-8161
jimukyoku@imeqrd.co.jp
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
| 2025 | Year | 07 | Month | 31 | 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
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063396
