UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034372