UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024254 |
|---|---|
| Receipt number | R000027869 |
| Scientific Title | A randomized, open-placebo-controlled crossover study to investigate the relief effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" on acute phase muscle fatigue. |
| Date of disclosure of the study information | 2016/10/02 |
| Last modified on | 2018/11/23 17:24:23 |
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Basic information
Public title
A randomized, open-placebo-controlled crossover study to investigate the relief effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" on acute phase muscle fatigue.
Acronym
The clinical trial for investigation of anti-fatigue effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI".
Scientific Title
A randomized, open-placebo-controlled crossover study to investigate the relief effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" on acute phase muscle fatigue.
Scientific Title:Acronym
The clinical trial for investigation of anti-fatigue effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI".
Region
| Japan |
Condition
Condition
The healthy adults who routinely take exercise.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical benefits, such as anti-fatigue effect, associated with ingestion of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" for the healthy adult with routinely take exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Maximum rotational speed on 10 seconds high power test by bicycle ergometer at pre- and post- exercise tolerance, four-hour rest after exercise, and the next day.
Key secondary outcomes
1. Fatigue related scales (VAS, modified Borg scale)
2. Fatigue related biochemical examination of blood and urine
3. Amino acid analysis
4. Adverse events.
(They are assessed at pre- and post-exercise tolerance, four-hour rest after exercise, and the next day except for adverse events.)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
The subjects are instructed to take 150 ml of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" at the time of pre-exercise tolerance and three times per hour during four-hour exercise.
Interventions/Control_2
The subjects are instructed to take 150 ml of "Pocari Sweat" with 28g of glucose at the time of pre-exercise tolerance and three times per hour during four-hour exercise.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who routinely take exercise (Average more than one-hour exercise per day).
3. Subjects who have no abnormality in clinical problems by screening tests.
4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases.
2. Subjects who can't take exercise tolerance by bicycle ergometer.
3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
4. Pre- or post-menopausal women having obvious changes in physical condition.
5. Subjects who are at risk of having allergic reaction to dairy product including milk and rice.
6. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction.
7. Subjects who don't take dairy product and rice even if there is any reason.
8. Subjects who are heavy smoker (more than 21 cigarettes per day), or alcohol addicts (more than 20g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency.
9. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
10. Pregnant or lactating women or women expect to be pregnant during this study.
11. Subjects who have cognitive disorder or who have possibility of the disorder.
12. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study.
13. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuji Arimura |
Organization
University of Miyazaki
Division name
Clinical research support center, University of Miyazaki hospital
Zip code
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985-85-9577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuji Arimura |
Organization
University of Miyazaki
Division name
Clinical research support center, University of Miyazaki hospital
Zip code
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985-85-9577
Homepage URL
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Hakusuisha Milk Industry Co. Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
宮崎大学医学部附属病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 02 | 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
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
| 2016 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 11 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 25 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 02 | Day |
Last modified on
| 2018 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027869
