UMIN-CTR Clinical Trial

Basic information
Public title	Effects of the Test Food for Physical Fatigue.
Acronym	Effects of the Test Food for Physical Fatigue.
Scientific Title	Effects of the Test Food for Physical Fatigue.
Scientific Title:Acronym	Effects of the Test Food for Physical Fatigue.
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate effects of the Test food for physical fatigue and its safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Indexes for evaluating fatigue (Visual Analogue Scale for fatigue and menopause , Japanese Translation of Chalder Fatigue Scale , Japanese Translation of Profile of Mood States).
Key secondary outcomes	*Safety [1]Blood pressure, pulsation. [2]Weight, body fat percentage, BMI. [3]Doctor's questions. [4]Subject's diary.

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
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test product A
Interventions/Control_2	Oral ingestion of the test product B
Interventions/Control_3	Oral ingestion of the placebo product
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	30 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Japanese males aged 30-64 years. [2]Individuals who are healthy and are not received treatment of disease. [3]Individuals who have daily fatigue. [4]Individuals who have shoulder stiffness, lower back pain, or eyestrain derived from fatigue. [5]Individuals who work on daytime from Monday to Friday and have Saturdays and Sundays off. [6]Individuals whose written informed consent has been obtained. [7]Individuals who can come to the designated venue for this study and be inspected. [8]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals who have chronic fatigue. [2]Individuals using medical products. [3]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [4]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [6]Individuals who are a patient or have a history of or endocrine disease. [7]Individuals whose BMI is over 30. [8]Individuals with serious anemia. [9]Individuals who are sensitive to a test product or other foods, and medical products. [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [11]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements with components contained in the test product in the past 3 month or will ingest those foods during the test period. [13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [14]Individuals who are or are possibly, or are lactating. [15]Individuals who participated in other clinical studies in the past 3 months. [16]Individuals who are or whose family is engaged in functional foods or cosmetics. [17]Individuals judged inappropriate for the study by the principal.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Taiyo Kagaku Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of the Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Address	1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN
Tel	+81-3-5816-0711
Email	jimukyoku@tes-h.co.jp

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

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 09 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
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 02 Month 06 Day
Date of IRB	2019 Year 01 Month 24 Day
Anticipated trial start date	2019 Year 02 Month 20 Day
Last follow-up date	2019 Year 03 Month 23 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 02 Month 20 Day
Last modified on	2019 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040766