UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051275 |
|---|---|
| Receipt number | R000058474 |
| Scientific Title | Effects of consumption of the test food on the cognitive function in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2024/04/03 10:23:33 |
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Basic information
Public title
Effects of consumption of the test food on the cognitive function in healthy Japanese subjects
Acronym
Effects of consumption of the test food on the cognitive function in healthy Japanese subjects
Scientific Title
Effects of consumption of the test food on the cognitive function in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on the cognitive function in healthy Japanese subjects
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 coffee cherry pulp extract for 12 weeks on cognitive function in healthy subjects with suspected mild cognitive impairment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value 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 and the amount of changes from Scr of the standardized scores of each cognitive domain {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}, Mini Mental State Examination (MMSE) score, and brain derived neurotrophic factor (BDNF) at 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
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Coffee cherry pulp extract (low amount)
Interventions/Control_2
Duration: 12 weeks
Test food: Coffee cherry pulp extract (high amount)
Interventions/Control_3
Duration: 12 weeks
Test food: Dextrin powder
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 or more
4. Healthy subjects
5. Subjects whose scoring of MMSE is 24 or more and 27 or less at Scr
6. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at Scr
7. Subjects who have relatively low standardized score in composite memory measured using Cognitrax at Scr
Key exclusion criteria
Subjects (who/whose)
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. are currently taking medications (including herbal medicines) and supplements
6. are allergic to medicines and/or the test food related products
7. are pregnant, lactating, or planning to become pregnant during this trial
8. 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
9. have dementia
10. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
11. 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
12. take blue-backed fish such as sardines, mackerel, and saury at least four times a week
13. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games)
14. sleeping time or habit is irregular due to work such as a late-night shift
15. amount of smoking varies widely from day to day
16. alcohol intake varies widely from day to day
17. have irregular lifestyles (such as diet, exercise, and sleep)
18. have caffeine sensitivity
19. take beverages with rich caffeine, such as coffee or energy drink in daily
20. are judged as ineligible to participate in this study by the physician
Target sample size
60
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
UCC UESHIMA COFFEE 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 Bldg., 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
| 2024 | 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
66
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
| 2023 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 28 | 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 | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058474
