UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044305 |
|---|---|
| Receipt number | R000050608 |
| Scientific Title | Effects of consumption of the test food on the cognitive function in healthy subjects 40 years old or more: a randomized, double-blind placebo-controlled trial |
| Date of disclosure of the study information | 2021/05/24 |
| Last modified on | 2022/02/25 13:40:06 |
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Basic information
Public title
Effects of consumption of the test food on the cognitive function in healthy subjects 40 years old or more
Acronym
Effects of consumption of the test food on the cognitive function in healthy subjects 40 years old or more
Scientific Title
Effects of consumption of the test food on the cognitive function in healthy subjects 40 years old or more: a randomized, double-blind placebo-controlled trial
Scientific Title:Acronym
Effects of consumption of the test food on the cognitive function in healthy subjects 40 years old or more
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on the cognitive function in healthy subjects 40 years old or more
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The measured values of the standardized score of composite memory at 12 weeks after consumption (12w)
Key secondary outcomes
1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) and 12w
2. The measured values of the standardized scores of Neurocognition Index (NCI), verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed, and brain derived neurotrophic factor (BDNF) at 12w
3.The amount of change of the standardized scores of NCI, verbal memory, visual memory, psychomotor speed, reaction time, complex attention, cognitive flexibility, processing speed, executive function, social acuity, reasoning, working memory, sustained attention, simple attention and motor speed, and BDNF between Scr and 12w
4. The measured values of all of the items of an original qustionaires at 4, 8, and 12w
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Food containing sugarcane stem extract
Administration: Take five capsules (100 mg sugarcane stem extract/capsule) with water after breakfast
* If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
Duration: 12 weeks
Test food: Food containing low sugarcane stem extract
Administration: Take five capsules (50 mg sugarcane stem extract/capsule) with water after breakfast
* If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_3
Duration: 12 weeks
Test food: Food not containing sugarcane stem extract
Administration: Take five capsules (without sugarcane stem extract) with water after breakfast
* If you forget to take the test food, take it as soon as you remember within the day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Subjects aged 40 years old or more
4. Healthy subjects
5. Subjects who are aware of the decline in their memory function
6. Subjects who are judged as eligible to participate in the study by the physician
7. Subjects who are judged as eligible to participate in the study by the physician according to the results of Beck depression inventory (BDI)-II
8. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory
9. Subjects who have 24 points or more of Mini Mental State Examination (MMSE)
10. Subjects who have a relatively low standardized score in composite memory by Cognitrax
Key exclusion criteria
1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects who are currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
4. Subjects who have dementia
5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
6. Subjects who are smokers
7. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
8. Subjects who take supplements related to improving cognitive functions, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, and plasmalogen in daily use
9. Subjects who take blue-backed fish such as sardines, mackerel, and saury more than four days per week
10. Subjects who regularly use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games)
11. Subjects who currently taking medicines (include herbal medicines) and supplements
12. Subjects who are allergic to medicines and/or the test food related products
13. Subjects who are pregnant, breast-feeding, or planning to become pregnant after the agreement to participate in this trial
14. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
15. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Mitsui Sugar Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 24 | 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
99
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
| 2021 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 07 | 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 | 05 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050608
