UMIN-CTR Clinical Trial

Basic information
Public title	A study to investigate responders to food ingredients - A randomized, double-blind, placebo-controlled, crossover study -
Acronym	A study to investigate responders to food ingredients
Scientific Title	A study to investigate responders to food ingredients - A randomized, double-blind, placebo-controlled, crossover study -
Scientific Title:Acronym	A study to investigate responders to food ingredients
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The study aims to investigate psychological effects of food ingredient intakes to explore responders
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychological evaluation Heart rate data
Key secondary outcomes	Genetic polymorphism Interoceptive sense Values and Personality survey Background survey (menstrual cycle, levels of menstrual pain, and beverage intake preferences) Beverages drinking patterns and behaviors Flavor evaluation BMI Stress Lifestyle (obesity)

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	6
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Participants will intake placebo (200 mL) within 15 minutes
Interventions/Control_2	Participants will intake test liquid 1(200 mL) within 15 minutes
Interventions/Control_3	Participants will intake test liquid 2(200 mL) within 15 minutes
Interventions/Control_4	Participants will intake test liquid 3(200 mL) within 15 minutes
Interventions/Control_5	Participants will intake test liquid 4(200 mL) within 15 minutes
Interventions/Control_6	Participants will intake test liquid 5(200 mL) within 15 minutes
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy men and women, aged 20-59 years, at the time of an informed consent 2) Subjects who have given written consent to participate in research conducted by DeNA Life Science using samples and information obtained through MYCODE, the genetic testing service 3) Subjects that are given sufficient explanation about the purpose and contents of the study, and those agreed and volunteered to participate with good understanding of the study 4) Subjects who are able to come to the designated study date and participate in the study 5) Subjects with BMI less than 30.0 6) Non-smokers (those that have not smoked in the past year)
Key exclusion criteria	1) Subjects who are receiving continuous pharmaceutical treatment 2) Subjects with previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive system) 3) Subjects who have hay fever (during the study period) and/or allergic rhinitis (seasonal or year-round) 4) Subjects who are receiving nutrition therapy or physical therapy under doctor's supervision 5) Subjects who are regularly taking OTC medicines, quasi-drugs, and/or any food/functional food claiming an effect on autonomic nervous system, metabolism, and sleep (except for those who will be able to quit taking these after agreeing to participate until the end of the study) 6) Subjects who drink excessively (drinking 60g of pure alcohol or more, for more than five days a week) 7) Subjects with extremely irregular life cycles (e.g., midnight shift work) and/or those with extremely irregular dining habits 8) Subjects with current or past (less than 1 month) experience of participating in other clinical studies at the time of informed consent, or those planning to participate in other clinical studies during or after (within four weeks) the study period 9) Subjects who might be under extreme stress due to large life events (e.g., changing jobs, moving, divorce) that has happened three months prior to agreeing to participate in the study 10) Subjects with difficulty not taking alcohol the day before their scheduled date of the study 11) Subjects with allergy to certain medicine and/or food 12) Subjects with defects in heart rate measurement (subjects with cardiac pacemakers or thick chest hair) 13) Subjects who cannot drink alcohol 14) Subjects who cannot drink energy drinks 15) Female subjects who are pregnant and/or lactating 16) Subjects with a severe symptom of PMS (premenstrual syndrome) 17) Any other subjects who are judged by the principal investigator responsible for the study to be inappropriate to participate in the study
Target sample size	102

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Yoneyama
Organization	DeNA Life Science, Inc
Division name	Member of the Board
Zip code	150-0002
Address	2-24-12, Shibuya, Shibuya-ku, Tokyo
TEL	0120-08-4946
Email	IRB_dis@dena.com

Public contact
Name of contact person	1st name Ryuichiro Middle name Last name Kurata
Organization	DeNA Life Science, Inc
Division name	MYCODE service Dept
Zip code	150-0002
Address	2-24-12, Shibuya, Shibuya-ku, Tokyo
TEL	0120-08-4946
Homepage URL
Email	IRB_dis@dena.com

Sponsor
Institute	DeNA Life Science, Inc
Institute
Department

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	The ethical committee of DeNA Life Science, Inc
Address	2-24-12, Shibuya, Shibuya-ku, Tokyo
Tel	0120-08-4946
Email	IRB_dis@dena.com

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 10 Month 01 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	Completed
Date of protocol fixation	2021 Year 07 Month 30 Day
Date of IRB	2021 Year 08 Month 10 Day
Anticipated trial start date	2021 Year 09 Month 17 Day
Last follow-up date	2021 Year 11 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	2021 Year 08 Month 20 Day
Last modified on	2021 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051642