UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043676 |
|---|---|
| Receipt number | R000049874 |
| Scientific Title | Clinical Study of Psychological Impact of Food Ingredients |
| Date of disclosure of the study information | 2022/04/04 |
| Last modified on | 2021/10/07 10:32:06 |
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Basic information
Public title
Clinical Study of Psychological Impact of Food Ingredients
Acronym
Clinical Study of Psychological Impact of Food Ingredients
Scientific Title
Clinical Study of Psychological Impact of Food Ingredients
Scientific Title:Acronym
Clinical Study of Psychological Impact of Food Ingredients
Region
| Japan |
Condition
Condition
Healthy adults
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 will be conducted.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic nervous system parameters
Key secondary outcomes
Uchida-Kraepelin Test
Number of blinks
STAI Self-Evaluation Questionnaire
Questionnaire to assess the flavor
Body weight, blood pressure and pulse
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Study food A will be ingested over a period of 5 minutes.
Interventions/Control_2
Study food B will be ingested over a period of 5 minutes.
Interventions/Control_3
Study food C will be ingested over a period of 5 minutes.
Interventions/Control_4
Placebo will be ingested over a period of 5 minutes.
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
| 35 | years-old | > |
Gender
Male
Key inclusion criteria
1.Aged 20 to under 35 at the time of informed consent
2.Japanese male
3.BMI of less than 25 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 drugs as needed)
2.Current or history of serious diseases such as heart, liver, kidney, gastrointestinal tract
3.Those who have any seasonal allergy or allergic rhinitis (seasonal/perennial) during the study
4.Under diet or 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 with functional claims, or health food that affects autonomic nervous system, metabolism, 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.Those whose eyes (e.g., exotropia, esotropia, eyelid ptosis,dry eyes) and eyelash shape are not suitable for pupillometry
7.Those who are aware of their claustrophobia or nyctophobia
8.Those who have a problem with heart rate measurement
9.Excessive consumption of alcohol (alcohol equivalent 60g or more / day)
10.Irregular diet, shift worker, night shift, irregular life rhythm
11.Those who has participated another clinical study within 1 month prior to provision of the informed consent 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
12.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
13.Those who has difficulty abstaining from alcohol starting from one day prior to the start of the study
14.Current or history of drug and/or food allergies
15.Those who is unable to drink alcohol and caffeine constitutionally
16.Those who do not like carbonated drinks
17.Those who regularly do any vigorous physical activity
18.Judged by the investigator to be unsuitable for participating in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Higashi Koganei Sakura Clinic
Division name
Chairman
Zip code
184-0011
Address
4-37-26,Higashicho,Koganei-shi,Tokyo,Japan
TEL
042-382-3081
higashikoganeisakura-clinic@imeq.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
h-kayama@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
03-6704-5968
n-yuzawa@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
| 2022 | Year | 04 | Month | 04 | 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
20
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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049874
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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