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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030145
Receipt No. R000034372
Scientific Title A double-blind, placebo controlled, randomized cross-over trial to evaluate the effect of milk peptides ingestion on thermoregulation and alleviate fatigue in healthy humans
Date of disclosure of the study information 2017/11/28
Last modified on 2019/06/05

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Basic information
Public title A double-blind, placebo controlled, randomized cross-over trial to evaluate the effect of milk peptides ingestion on thermoregulation and alleviate fatigue in healthy humans
Acronym A double-blind, placebo controlled, randomized cross-over trial to evaluate the effect of milk peptides ingestion on thermoregulation and alleviate fatigue in healthy humans
Scientific Title A double-blind, placebo controlled, randomized cross-over trial to evaluate the effect of milk peptides ingestion on thermoregulation and alleviate fatigue in healthy humans
Scientific Title:Acronym A double-blind, placebo controlled, randomized cross-over trial to evaluate the effect of milk peptides ingestion on thermoregulation and alleviate fatigue in healthy humans
Region
Japan

Condition
Condition NA
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of milk peptides ingestion on thermoregulation and alleviate fatigue in health humans
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body temperature (body core temperatures and skin temperatures), Sweat rate, Skin blood flow, Cutaneous vascular conductance, Exercise duration, Fatigue sensation, Rate of perceived exertion, Profile of mood states-brief form Japanese version, and thermal and comfort sensations
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 YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single oral peptide intake
Interventions/Control_2 Single oral placebo intake
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

Not applicable
Gender Male
Key inclusion criteria Aged 20 or older
Key exclusion criteria 1) Subjects with a food allergy.
2) Subjects who are impregnated, intent to be pregnant during this study or provide breast milk.
3) Subjects who take any protein or amino acid supplementation(s) for the purpose of muscle hypertrophy.
4) Subjects who take supplementation for the purpose of alleviation of fatigue.
5) Subjects who have a smoking habit.
6) Subjects who receive take prescription treatment for chronic diseasemedication(s)
7) Subjects who take oral contraceptivesbirth-control pills.
8) Subjects who are regarded as judged inappropriate participation for the study for the study by the physicianinvestigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tatsuro
Middle name
Last name Amano
Organization Niigata University
Division name Faculty of Education
Zip code 950-2181
Address 8050, Igarashi 2, Nishi-ku, Niigata, Niigata
TEL 025-262-7161
Email amano@ed.niigata-u.ac.jp

Public contact
Name of contact person
1st name Tatsuro
Middle name
Last name Amano
Organization Niigata University
Division name Faculty of Education
Zip code 950-2181
Address 8050, Igarashi 2, Nishi-ku, Niigata, Niigata
TEL 025-262-7161
Homepage URL
Email amano@ed.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Morinaga 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 Human ethical committee of Niigata University
Address 8050, Igarashi 2, Nishi-ku, Niigata, Niigata
Tel 025-227-2625
Email ethics@adm.niigata-u.ac.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 新潟大学 人文社会科学系(新潟県)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 28 Day

Related information
URL releasing protocol
Publication of results Partially 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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 06 Day
Date of IRB
2017 Year 11 Month 06 Day
Anticipated trial start date
2017 Year 11 Month 06 Day
Last follow-up date
2019 Year 12 Month 25 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 11 Month 28 Day
Last modified on
2019 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034372

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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