UMIN-CTR Clinical Trial

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
Email	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
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049665