UMIN-CTR Clinical Trial

Basic information
Public title	A verification study for improving on the fatigue with consumption of test food
Acronym	A verification study for improving on the fatigue with consumption of test food
Scientific Title	A verification study for improving on the fatigue in a daily life with consumption of test food in healthy subjects: a randomized, single-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym	A verification study for improving on the fatigue in a daily life with consumption of test food in healthy 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 the test food on the transient physical and mental fatigue in a daily life on the healthy subjects
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Questionnaire of fatigue (established by Japanese Society of Fatigue Science)
Key secondary outcomes	1. MOS Short-Form 36-Item Health. Survey (SF-36) 2. Scoring of immunological vigor 3. T lymphocyte age 4. Immunological age 5. Lymphocyte subset 6. Salivary immunoglobulin A (sIgA) 7. Profile of Mood States 2nd Edition (POMS2) Japanese version

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 4 weeks Test food: Administration: Take 4 tablets with water after dinner
Interventions/Control_2	Duration: 4 weeks Placebo food: Administration: Take 4 tablets with water after dinner
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adult subjects 2. Subjects who feel fatigue in daily 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met 1st to 3rd inclusion criteria, subjects are selected in the descending order of VAS of fatigue. The scores of "Vigor-Activity" and "Fatigue-Inertia" of POMS2, and "Vitality" of SF-36 are taken into consideration.
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, gastrointestinal disorder, or any other chronic diseases 4. Subjects who are diagnosed with eosinophilia 5. Subjects who have the medical history or under the treatment of Shiitake dermatitis 6. Subjects who are diagnosed with photosensitivity 7. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 8. Subjects who are currently taking medications (including herbal medicines) and supplements 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are smokers 11. Subjects who are pregnant, lactation, or planning to become pregnant 12. 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 enroll in anther clinical trial during trial period 13. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

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	KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara 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	info@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)

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 20 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	2019 Year 03 Month 04 Day
Date of IRB	2019 Year 03 Month 04 Day
Anticipated trial start date	2019 Year 06 Month 21 Day
Last follow-up date	2019 Year 10 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 20 Day
Last modified on	2019 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042298