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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027548
Receipt No. R000031485
Scientific Title Effect of a Test Food on Memory and Its Safety
Date of disclosure of the study information 2017/05/31
Last modified on 2018/01/23

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Basic information
Public title Effect of a Test Food on Memory and Its Safety
Acronym Effect of a Test Food on Memory and Its Safety
Scientific Title Effect of a Test Food on Memory and Its Safety
Scientific Title:Acronym Effect of a Test Food on Memory 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 memory and its safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Wechsler Memory Scale-Revised (Week 0, Week 16)
Key secondary outcomes *Secondary outcomes
[1]SF-36v2, Japanese version (Week 0, Week 8, Week 16)
[2]Questionnaire of physical feeling (Week 8, Week 16)

*Safety evaluation
[1]Blood pressure, pulsation (Week 0, Week 8, Week 16)
[2]Weight, body fat percentage, BMI (Week 0, Week 8, Week 16)
[3]Doctor's questions (Week 0, Week 8, Week 16)
[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; 16 weeks)
Interventions/Control_2 Oral intake of the placebo product (4 capsules one time in a day; 16 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
40 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1)Japanese males and females aged 40-69 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 forgetfulness or whose forgetfulness have been indicated by others.
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 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuzo Hanada
Organization Medical Corporation SOUSEIKAI Sumida Hospital
Division name Internal Medicine
Zip code
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
1st name
Middle name
Last name Ryoma Shimizu
Organization TES Holdings Co., Ltd
Division name Administrative Department of Clinical Trials
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 05 Month 31 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
2017 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 30 Day
Last modified on
2018 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031485

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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