UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029238 |
|---|---|
| Receipt number | R000033003 |
| Scientific Title | Efficacy of functional milk which produces hydrogen gas in the human intestine on recovery after intense exercise. |
| Date of disclosure of the study information | 2017/09/25 |
| Last modified on | 2020/11/24 09:56:23 |
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Basic information
Public title
Efficacy of functional milk which produces hydrogen gas in the human intestine on recovery after intense exercise.
Acronym
Recovery effect of functional milk which produces hydrogen gas.
Scientific Title
Efficacy of functional milk which produces hydrogen gas in the human intestine on recovery after intense exercise.
Scientific Title:Acronym
Recovery effect of functional milk which produces hydrogen gas.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of functional milk which produces hydrogen gas in the human intestine on recovery after intense exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxidative-stress markers (d-ROMs, TBARS, protein carbonyl) are measured at pre-ingestion of functional milk, pre-exercise, post-exercise, and next morning.
Key secondary outcomes
Blood biomarker, Urinary biomarker, Salivary biomarker, Breath hydrogen concentration, Cutaneous barrier, Analyses of fecal samples, Performance test, VAS
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Experimental day: ingestion of 200 mL of functional milk once
Control day: ingestion of 200 mL of placebo once
Interventions/Control_2
Experimental day: pedalling exercise at 75%VO2max for 1 hour once
Control day: pedalling exercise at 75%VO2max for 1 hour once
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
healthy adult male
Key exclusion criteria
food allergy (milk)
severe lactose intolerance
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiko Eda |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15, Mikajima, Tokorozawa, Saitma 359-1192
TEL
04-2947-6721
nob-eda@aoni.waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuharu Matsumoto |
Organization
Kyodo Milk Industry Co. Ltd.
Division name
Research Laboratories
Zip code
Address
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182
TEL
042-597-5911
Homepage URL
m-matumoto@meito.co.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Kyodo Milk Industry 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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 25 | 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
| 2017 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 22 | Day |
Last modified on
| 2020 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033003
