UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054532 |
|---|---|
| Receipt number | R000062302 |
| Scientific Title | A study to evaluate effects of test food containing plant extracts on cognitive function: a randomized, placebo controlled, double-blind, parallel group comparison study. |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2024/07/22 10:41:57 |
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Basic information
Public title
The effect of test foods containing plant extracts on cognitive function
Acronym
The effect of test foods containing plant extracts on cognitive function
Scientific Title
A study to evaluate effects of test food containing plant extracts on cognitive function: a randomized, placebo controlled, double-blind, parallel group comparison study.
Scientific Title:Acronym
A study to evaluate effects of test food containing plant extracts on cognitive function.
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the improving effects of the test foods containing plant extracts on cognitive function.
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 24 weeks after consumption (24w), and the amount and rate of change of it from screening (before consumption; Scr)
Key secondary outcomes
1. The measured value of the standardized score of composite memory at 12 weeks after intervention (12w), and the amount and rate of change of it from Scr
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 at 12w and 24w, and the amount and rate of changes of them from Scr
3. The measured value of score in the Japanese version of Montreal Cognitive Assessment (MoCA-J) at 12w and 24w, and the amount and rate of change from Scr
4. The measured value of total score in the self-administered dementia checklist at 12w and 24w, and the amount and rate of change from Scr
5. The measured value of score in the MIRUDAKE at 12w and 24w, and the amount and rate of change from Scr
6. The measured value of score in the CogEvo at 12w and 24w, and the amount and rate of change from Scr
7. The measured value of high sensitivity C-reactive protein (CRP) at 12w and 24w, and the amount and rate of change from Scr
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take two capsules per day of the active food (soft capsules with plant extracts) (24 weeks)
Interventions/Control_2
Take two capsules per day of the placebo food (soft capsules without plant extracts) (24 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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men and women
3. Individuals aged between 40 and 69 at the time of agreement to participate in this study
4. Healthy individuals
5. Individuals who notice a decline in memory
6. Individuals whose scoring of the Japanese version of the Mini Mental State Examination (MMSE-J) is 24 or more at Scr
7. Individuals whose scoring of the Japanese version of the MoCA (MoCA-J) is 20 or more at Scr
8. Individuals who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at Scr
9. Individuals who have relatively low standardized score in composite memory measured using Cognitrax at Scr
Key exclusion criteria
Individuals (who/whose)
1. are under treatment or have a history of serious diseases of the heart, liver, kidneys, digestive organs, or others
2. are under treatment or have a history of cardiovascular disease, especially malignant tumor, heart failure, or myocardial infarction
3. have a pacemaker or an implantable cardioverter defibrillator
4. under treatment for any of chronic disease such as cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, or hypertension
5. have dementia
6. with suspected insomnia
7. are under treatment or have a history of psychiatric disorder (including depressive symptoms) or cerebrovascular disease
8. drink pure alcohol >= 40 g/day (men) or >= 20 g/day (women)
9. are smokers
10. have a disability of both hands by injuries, surgeries, or other reasons
11. have extremely irregular eating habits or irregular lifestyles by shift work, night work, or other reasons
12. take "Foods for Specified Health Uses" or "Foods with Functional Claims"
13. take medicines (including herbal medicines) or supplements, especially antipsychotic, anti-anxiety, antidepressants, anti-Parkinson, antimanic, antiepileptic, or anticoagulant
14. with allergies (medicines or foods related to test products), especially turmeric
15. are pregnant, lactating, or planning to become pregnant during this study
16. enrolled in other studies within 28 days before the agreement to participate or plan to participate other studies during this study
17. donated blood within one month before the agreement to participate in this study
18. donated 400 mL of whole blood within three months (men) or four months (women) before the agreement to participate in this study
19. blood collection volume exceeds 1,200 mL (men) or 800 mL (women) from 12 months before the agreement to participate until completion of this study
20. are judged as ineligible to participate in this study by the physician
Target sample size
36
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
House Wellness Foods Corporation
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
40
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062302
