UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027548 |
|---|---|
| Receipt number | 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 11:42:55 |
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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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031485
