UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044987 |
|---|---|
| Receipt number | R000051360 |
| Scientific Title | A study of the effect of food ingredient on cerebral blood flow. (SIC-2021-05-SHKBSN) |
| Date of disclosure of the study information | 2021/08/23 |
| Last modified on | 2021/07/26 12:08:55 |
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Basic information
Public title
A study of the effect of food ingredient on cerebral blood flow. (SIC-2021-05-SHKBSN)
Acronym
A study of the effect of food ingredient on cerebral blood flow. (SIC-2021-05-SHKBSN)
Scientific Title
A study of the effect of food ingredient on cerebral blood flow. (SIC-2021-05-SHKBSN)
Scientific Title:Acronym
A study of the effect of food ingredient on cerebral blood flow. (SIC-2021-05-SHKBSN)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of food ingredients on cerebral blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cerebral blood flow
Key secondary outcomes
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingredient A-containing food (12 weeks)
Interventions/Control_2
Ingredient B-containing food (12 weeks)
Interventions/Control_3
Ingredient-free food (12 weeks)
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who can make self-judgment and are voluntarily giving written informed consent.
(2) From 50 to 65 years healthy men and women.
Key exclusion criteria
(1) Subjects who are under medication for dementia, Alzheimer's disease, psychiatric disorder and cerebrovascular disease.
(2) Subjects who have a history or are suspected patient of cranial nerve disease and psychiatric disorders.
(3) Subjects who have serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
(4) Subjects who are with diabetes mellitus.
(5) Subjects who have major surgical history relevant to the digestive system such as gastrectomy, gastrointestinal suture, or intestinal resection.
(6) Subjects who are with systolic blood pressure of less than 90 mmHg.
(7) Subjects who have unusually high and/or low blood pressure and/or abnormal hematological data.
(8) Pre- or post-menopausal women complaining of obvious physical changes.
(9) Subjects who experienced unpleasant feeling during drawing blood.
(10) Subjects who have difficulty in blood collection from peripheral veins.
(11) Subjects whose blood hemoglobin level is less than 13 g/dL for males and less than 12 g/dL for female.
(12) Subjects who have metal such as aneurysm clips, bone fixation plates in the head.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Watanabe |
Organization
Suntory global innovation center limited.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, JAPAN
TEL
050-3182-0593
H_Watanabe@suntory.co.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Nakamura |
Organization
Suntory global innovation center limited.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, JAPAN
TEL
050-3182-2513
Homepage URL
Yumi_Nakamura@suntory.co.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Suntory global innovation center limited.
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 ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, JAPAN
Tel
011-385-4411
soumu@do-johodai.ac.jp
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
| 2021 | Year | 08 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 08 | 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 | 07 | Month | 28 | Day |
Last modified on
| 2021 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051360
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