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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039610
Receipt No. R000045172
Scientific Title Verification study of anti-fatigue effect by ingestion of test beverage
Date of disclosure of the study information 2020/03/09
Last modified on 2020/08/26

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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 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
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 08 Month 26 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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