UMIN-CTR Clinical Trial

Basic information
Public title	Verification study of anti-fatigue effect by ingestion of test beverage
Acronym	Verification study of anti-fatigue effect by ingestion of test beverage
Scientific Title	Verification study of anti-fatigue effect by ingestion of test beverage
Scientific Title:Acronym	Verification study of anti-fatigue effect by ingestion of test beverage
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of test beverage ingestion on fatigue
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fatigue index using questionnaires after 2-week ingestion of test beverage
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test beverage for 2 weeks -> Washout for 2 weeks or more -> Intake of placebo beverage for 2 weeks
Interventions/Control_2	Intake of placebo beverage for 2 weeks -> Washout for 2 weeks or more -> Intake of test beverage for 2 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	50 years-old <=
Age-upper limit	64 years-old >=
Gender	Female
Key inclusion criteria	(1) Females aged between 50 and 64 years old who feel fatigue (2) Subjects who have received sufficient explanation about the purpose and content of the study, have the ability to consent, voluntarily volunteered to participate, and agreed to participate it by signing the written informed consent
Key exclusion criteria	(1) Subjects who have history of diabetes, liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disease, or other serious disease (2) Subjects who are judged by the principal investigator to have abnormal electrocardiogram (3) Subjects who have injuries or illnesses that interfere with ergometer exercise (4) Subjects who are under medical treatment (5) Subjects who are allergic to food and drugs (6) Subjects who cannot avoid taking health foods (including Food for Specified Health Uses, and Foods with Function Claims) and designated quasi-drugs during the test period (7) Subjects who are taking medication (including OTC and prescription drugs) (8) Subjects who have excessive alcohol consumption, or not avoid consumption of alcohol from the day before the test until the end of the test (9) Subjects who are planning to get pregnant after the day of informed consent or are currently pregnant and lactating (10) Subjects who have participated or are planning to participate in other clinical studies during the current study (11) Subjects who are judged ineligible at the discretion of the principal investigator
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
Zip code	530-0044
Address	9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	tterashima@miula.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Terashima
Organization	Oneness support Co., Ltd.
Division name	Clinical trial Division
Zip code	530-0044
Address	4F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-4801-8917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Morinaga & Co.,Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Miura Clinic, Medical Corporation Kanonkai IRB
Address	9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka
Tel	06-6135-5200
Email	tterashima@miula.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	医療法人花音会みうらクリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
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	Main results already published
Date of protocol fixation	2020 Year 02 Month 20 Day
Date of IRB	2020 Year 02 Month 20 Day
Anticipated trial start date	2020 Year 02 Month 21 Day
Last follow-up date	2020 Year 06 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 26 Day
Last modified on	2020 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045172