UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect on concentration (and cognitive function) by single ingestion of a test food
Title of the study (Brief title)	Effect on concentration (and cognitive function) by single ingestion of a test food
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study was to investigate the effect of a single dose of the test food on concentration in healthy Japanese men and women aged 30 years or older and younger than 50 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitrax,Uchida Kraepelin test
Key secondary outcomes	POMS2 shorter version,VAS questionnaire,Salivary marker

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	On the day intake of the test food Wash out On the day intake of the placebo
Interventions/Control_2	On the day intake of the placebo Wash out On the day intake of the test food
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	30 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	1)Japanese men and women aged 30 to younger than 50 at the time of informed consent 2)Non smoker 3)A person who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Key exclusion criteria	1)Patients currently receiving any type of drug or outpatient treatment 2)Subjects who are currently receiving exercise or dietary therapy under the supervision of a physician. 3)Persons with a history or current or concurrent liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease. 4)Patients with a history of drug or food allergy 5)Those who wish to do so during pregnancy, lactation, or the duration of the study. 6)Persons with serious or past brain diseases. 7)Subjects who have received blood donations or vaccinations within the previous 3 months or have scheduled them during the study period. 8)People who routinely consume health foods, supplements, and medicines that may affect concentration 9)Persons with a history of psychiatric disorders (e.g., depression), sleep disorders, or psychiatric disorders in the past. 10)Alcoholism, substance abuse, or substance abuse with treatment or a history of treatment. 11)Employees working during night shifts, etc. 12)Excessively irregular lifestyle such as eating or sleeping 13)Subjects who have participated in other clinical studies or have participated in other clinical studies within the previous 3 months. 14)Persons who are difficult to comply with the records of various surveys 15)Other than the above, the principal investigator judged that the subject was ineligible for the study.
Target sample size	80

Research contact person
Name of lead principal investigator	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Asahi Group Holdings,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 13 Day
Anticipated trial start date	2018 Year 08 Month 20 Day
Last follow-up date	2018 Year 10 Month 20 Day
Date of closure to data entry	2018 Year 10 Month 29 Day
Date trial data considered complete	2018 Year 10 Month 29 Day
Date analysis concluded	2018 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 07 Month 31 Day
Last modified on	2019 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038268