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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029238
Receipt No. 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 2018/03/28

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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
Email 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
Email m-matumoto@meito.co.jp

Sponsor
Institute Waseda University
Institute
Department

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
Email

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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
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
2018 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033003

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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