UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Study of Psychological Impact of Food Ingredients -(1)
Acronym	Clinical Study of Psychological Impact of Food Ingredients -(1)
Scientific Title	Clinical Study of Psychological Impact of Food Ingredients -(1)
Scientific Title:Acronym	Clinical Study of Psychological Impact of Food Ingredients -(1)
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 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	1. Questionnaires to assess the psychological impact
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	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	Study food 1 will be ingested over a period of 15 minutes.
Interventions/Control_2	Placebo will be ingested over a period of 15 minutes.
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	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 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 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 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	40

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	042-382-3081
Email	higashikoganeisakura-clinic@imeq.co.jp

Public contact
Name of contact person	1st name Kohei Middle name Last name Yoshida
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
Email	koh_yoshida@macromill.com

Sponsor
Institute	Macromill, Inc.
Institute
Department

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	03-6704-5968
Email	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	2023 Year 09 Month 14 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	2022 Year 09 Month 30 Day
Date of IRB	2022 Year 09 Month 30 Day
Anticipated trial start date	2022 Year 10 Month 01 Day
Last follow-up date	2022 Year 10 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 09 Month 30 Day
Last modified on	2022 Year 09 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055908