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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023587
Receipt No. R000027165
Scientific Title The effects of amino acids mixture during exercise
Date of disclosure of the study information 2016/08/19
Last modified on 2017/02/09

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Basic information
Public title The effects of amino acids mixture during exercise
Acronym The effects of amino acids mixture during exercise
Scientific Title The effects of amino acids mixture during exercise
Scientific Title:Acronym The effects of amino acids mixture during exercise
Region
Japan

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

Objectives
Narrative objectives1 To compare the effects of amino acid mixture with placebo during exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood cortisol
Key secondary outcomes Questionnaire
Blood glucose
Blood ACTH
Blood CK
Blood lactate
Blood NH3
Blood free fatty acid
Blood total ketone bodies

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 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Exercise A after ingestion of test product-> Washout-> Exercise A after ingestion of control product-> Washout-> Exercise B after ingestion of test product
Washout-> Exercise B after ingestion of control product
Interventions/Control_2 Exercise A after ingestion of control product-> Washout-> Exercise B after ingestion of control product-> Washout-> Exercise A after ingestion of test product
Washout-> Exercise B after ingestion of test product
Interventions/Control_3 Exercise B after ingestion of test product-> Washout-> Exercise A after ingestion of test product-> Washout-> Exercise B after ingestion of control product-> Washout-> Exercise A after ingestion of control product
Interventions/Control_4 Exercise B after ingestion of control product-> Washout-> Exercise B after ingestion of test product-> Washout-> Exercise A after ingestion of control product
Washout-> Exercise A after ingestion of test product
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
40 years-old >
Gender Male
Key inclusion criteria 1)Subjects who have given written informed consent
2)Healthy males aged 20 to 39 years old
3)Subjects whose BMI ranges from 18.5 to 25.0
4)Subjects whose blood cortisol increased during exercise at screening
Key exclusion criteria 1)Subjects with food allergies
2) Subjects having a smoking habit
3) Subjects who had blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study
4)Subjects who are currently participating in other clinical studies
5)Subjects who are judged as ineligible by the doctor for other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhisa Sakano
Organization CPCC Company Limited
Division name Clinical Reserch Planning Department
Zip code
Address 4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL 03-5297-3112
Email k.s@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ichinohe
Organization CPCC Company Limited
Division name Plan Sales Department
Zip code
Address 4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL 03-5297-3112
Homepage URL
Email m.i@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Meiji 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 チヨダパラメディカルケアクリニック(東京都)/Chiyoda Paramedical Care Clinic(Tokyo)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 19 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
2016 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 20 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
2016 Year 08 Month 10 Day
Last modified on
2017 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027165

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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