UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030145 |
|---|---|
| Receipt number | 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 | 2020/06/01 16:55:12 |
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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
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
amano@ed.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
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
Completed
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
| 2020 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034372
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
