UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of a Test Food on Information Processing and Its Safety
Title of the study (Brief title)	Effect of a Test Food on Information Processing and Its Safety
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effect of a test food on information processing and its safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Wechsler Adult Intelligence Scale - Third Edition (Week 0, Week 24).
Key secondary outcomes	*Secondary outcomes [1]SF-36v2, Japanese version (Week 0, Week 12, Week 24) [2]Questionnaire of physical feeling (Week 12, Week 24) *Safety evaluation [1]Blood pressure, pulsation (Week 0, Week 12, Week 24) [2]Weight, body fat percentage, BMI (Week 0, Week 12, Week 24) [3]Doctor's questions (Week 0, Week 12, Week 24) [4]Subject's diary (each day during the test period) *Other index [1]Mini Mental State Examination (Week 0)

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of the test product (4 capsules one time in a day; 24 weeks)
Interventions/Control_2	Oral intake of the placebo product (4 capsules one time in a day; 24 weeks)
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	35 years-old <=
Age-upper limit	55 years-old >
Gender	Male and Female
Key inclusion criteria	1)Japanese males and females aged 35-54 years. 2)Individuals being healthy and are not suffered from a chronic malady. 3)Individuals having healthy cognitive function. 4)Individuals having self-awareness of disability of information processing. 5)Individuals whose written informed consent has been obtained. 6)Individuals who can come to the designated venue for this study and be inspected. 7)Individuals judged appropriate for the study by the principal.
Key exclusion criteria	1)Individuals using medical products. 2)Individuals using a drug to treat a disease. 3)Individuals having cognitive impairment or mild cognitive impairment. 4)Individuals having visually impairment or hearing impairment. 5)Individuals who used psychotropic drugs in the past 1 month. 6)Individuals having a history of surgery for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, head trauma. 7)Individuals being patient or have a history of hypertension, hyperlipidemia and diabetes. 8)Individuals being patient or have a history of heart failure, kidney failure, and hepatitis B or C. 9)Individuals being patient or have a history of serious hepatopathy, kidney damage, heart disease, lung disease and hematological disease. 10)Individuals being a patient or have a history of endocrine disease. 11)Individuals whose BMI is over 30 kg/m2. 12)Individuals taking alcohol excessively (expressed in an amount of alcohol: over 60g/day). 13)Individuals whose average number of cigarettes for smoking is over 21/day. 14)Individuals with serious anemia. 15)Individuals being sensitive to test product or other foods, and medical products. 16)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements with similar efficacy to test product in the past 3 months or will ingest those foods during the test period. 17)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing active ingredient of the test product in the past 3 months or will ingest those foods during the test period. 18)Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. 19)Individuals who participated in other clinical studies in the past 3 months. 20)Individuals being or whose family is engaged in healthy or functional foods. 21)Individuals judged inappropriate for the study by the principal.
Target sample size	100

Research contact person
Name of lead principal investigator	Ryuzo Hanada
Organization	Medical Corporation SOUSEIKAI Sumida Hospital
Division name	Internal Medicine
Address	Random Square Honjo, 1-29-1 Honjo Sumida-ku Tokyo, 130-0004 JAPAN
TEL	03-5608-7276
Email	info@tes-h.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd
Division name	Administrative Department of Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
Institute
Department

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

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 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 01 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 02 Month 01 Day
Last modified on	2018 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035148