UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039610 |
|---|---|
| Receipt number | 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 | 2020/11/25 18:51:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Morinaga & Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045172
