UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053149 |
|---|---|
| Receipt number | R000060661 |
| Scientific Title | A study to analysis the relationship between cognitive function, hyperglycemia and immune cell function. |
| Date of disclosure of the study information | 2024/02/06 |
| Last modified on | 2023/12/19 09:46:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to analysis the relationship between cognitive function, hyperglycemia and immune cell function.
Acronym
A study to analysis the relationship between cognitive function, hyperglycemia and immune cell function.
Scientific Title
A study to analysis the relationship between cognitive function, hyperglycemia and immune cell function.
Scientific Title:Acronym
A study to analysis the relationship between cognitive function, hyperglycemia and immune cell function.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis the relationship between cognitive function, hyperglycemia and immune cell function after continuous consumption of food ingredients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immune cell function
Key secondary outcomes
Cognitive function
HbA1c
Fasting blood glucose
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingredient A-containing food (18 weeks)
Interventions/Control_2
Ingredient-free food (18 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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) From 50 to 75 years healthy men and women
(2) Subjects with high HbA1c
(3) Subjects with subjective symptoms of forgetfulness
(4) Subjects who can visit hospital on designated day
(5) Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
(1) Subjects who are under medication for dementia, Alzheimer's disease, psychiatric disorder and cerebrovascular disease.
(2) Subjects with diabetes or suspected diabetes.
(3) Subjects whose MMSE score is lower than 24.
(4) Subjects who regularly use medicines, health foods or supplements that may affect cognitive function or blood glucose levels.
(5) Subjects who have difficulty in implementation of neuropsychological test.
(6) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Ito |
Organization
Sun Thera Bio Limited
Division name
Research and Development
Zip code
213-0012
Address
West 4F Neo G5, KSP Innovation Center, 3-2-1 Sakado Takatsu-ku, Kawasaki city, Kanagawa prefecture
TEL
044-281-9701
mitoh@suntherabio.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Katsube |
Organization
Sun Thera Bio Limited
Division name
Research and Development
Zip code
213-0012
Address
West 4F Neo G5, KSP Innovation Center, 3-2-1 Sakado Takatsu-ku, Kawasaki city, Kanagawa prefecture
TEL
044-281-9701
Homepage URL
mkatsube@suntherabio.com
Sponsor or person
Institute
Sun Thera Bio Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics review committee of Ueno Asagao Clinic
Address
Kairaku Bld.6F, 2-7-5 Higashiueno, Taito-Ku, Tokyo Metropolis
Tel
03-6240-1162
info@ueno-asagao.clinic
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
| 2024 | Year | 02 | Month | 06 | 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
| 2023 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060661
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
