UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043492 |
|---|---|
| Receipt number | R000049665 |
| Scientific Title | A verification study for the effects of consumption of the test food on the improvement of brain fatigue: A randomized, double-blind, placebo-controlled, parallel-group comparison trial |
| Date of disclosure of the study information | 2021/03/02 |
| Last modified on | 2022/08/05 14:06:54 |
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Basic information
Public title
A verification study for the improvement of brain fatigue
Acronym
A verification study for the effects of consumption of the test food on the improvement of brain fatigue
Scientific Title
A verification study for the effects of consumption of the test food on the improvement of brain fatigue: A randomized, double-blind, placebo-controlled, parallel-group comparison trial
Scientific Title:Acronym
A verification study for the effects of consumption of the test food on the improvement of brain fatigue
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 the test food on the improvement of brain fatigue
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 values of Visual Analogue Scale (VAS) of fatigue at before and after the fatigue load of four weeks after the start of test food consumption
Key secondary outcomes
1. The measured values of VAS of fatigue at before and after the fatigue load of two weeks after the start of test food consumption (2w)
2. The amount of changes of VAS of fatigue at before and after the fatigue load from screening (before consumption; Scr) to 2w and four weeks after the start of test food consumption (4w)
3. The measured values of VAS of fatigue at before the fatigue load and after the fatigue load at 2w and 4w, and the amount of changes from Scr to 2w and 4w
4. The measured values of standardized score in each cognitive domain by Cognitrax at 2w and 4w, and the amount of changes from Scr to 2w and 4w
5. The measured values of flicker value (average of both eyes, dominant eye, and non-dominant eye), and VAS {sharp mind, concentration, thinking ability, brain (mental) fatigue, motivation (commitment), stress, frustration, stiff shoulder (fatigue in the shoulders), malaise (languor), and eye fatigue} at before, after, and before and after the fatigue load at 2w and 4w, and the amount of changes from Scr to 2w and 4w
6. The measured values of "My head doesn't feel clear when I wake up from sleep," "My head doesn't feel clear in the evening," "My sleep quality is not good," "I am concerned about my body odor," and "I am concerned about odor in my mouth" at 2w and 4w
* The value of "before and after the fatigue load" is defined as value subtracted after the fatigue load from before the fatigue load.
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: Four weeks
Test food: Tablet containing garlic extract
Administration: Take two tablets within 30 minutes after breakfast.
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
Duration: Four weeks
Test food: Placebo
Administration: Take two tablets within 30 minutes after breakfast.
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Male or female
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects who are judged as eligible to participate in the study by the physician
6. Subjects who have a relatively big difference in VAS of fatigue between before and after the fatigue load
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
5. Subjects who take supplements related to improving cognitive functions, such as garlic extract, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, astaxanthin, and gamma-aminobutyric acid (GABA) in daily
6. Subjects who use tools, games, devices, and application related to improving cognitive functions such as Shogi, Go, and puzzle or game of brain training in daily
7. Subjects currently taking medicines (include herbal medicines) and supplements
8. Subjects who are allergic to medicines and/or the test food related products
9. Subjects who are pregnant, breast-feeding, and planning to become pregnant
10. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
11. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
20
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 Building, 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
Bizen Chemical 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 | 03 | Month | 02 | 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
22
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 | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 19 | 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 | 03 | Month | 02 | Day |
Last modified on
| 2022 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049665
