UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025842 |
|---|---|
| Receipt number | R000029716 |
| Scientific Title | A study for evaluating the effect of oral supplementation using gamma-aminobutyric acid (GABA) and whey protein on muscle hypertrophy in men |
| Date of disclosure of the study information | 2017/01/25 |
| Last modified on | 2017/01/25 17:18:15 |
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Basic information
Public title
A study for evaluating the effect of oral supplementation using gamma-aminobutyric acid (GABA) and whey protein on muscle hypertrophy in men
Acronym
A study for evaluating the effect of oral supplementation using gamma-aminobutyric acid (GABA) and whey protein on muscle hypertrophy in men
Scientific Title
A study for evaluating the effect of oral supplementation using gamma-aminobutyric acid (GABA) and whey protein on muscle hypertrophy in men
Scientific Title:Acronym
A study for evaluating the effect of oral supplementation using gamma-aminobutyric acid (GABA) and whey protein on muscle hypertrophy in men
Region
| Japan |
Condition
Condition
Healthy men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to evaluate whether GABA with whey protein enhanced muscular hypertrophy in men after progressive resistance training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total body fat-free mass
Key secondary outcomes
resting plasma growth hormone concentrations
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food containing 100 mg of GABA and 10 g of whey protein once a day for 12 weeks
Interventions/Control_2
Intake of control food containing 10 g of whey protein once a day for 12 weeks
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
| 25 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy men aged 25 to 49
2) Subjects who do not exercise daily
Key exclusion criteria
1) Subjects who routinely use foods, supplements or medicines containing GABA and/or whey protein
2) Subjects who have been diagnosed for and who are under any medical treatment
3) Subjects who deviated from the conditions prescribed for ingestion of the test foods and strength training
4) Subjects who practice exercises other than the ones prescribed for strength training
5) Subjects who are judged as unsuitable for the study by a physician for any other reason
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maya Sakashita |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development Department
Zip code
Address
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL
075-394-8605
m-sakashita@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maya Sakashita |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development Department
Zip code
Address
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL
075-394-8605
Homepage URL
m-sakashita@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
PF0082
Org. issuing International ID_1
The Ethics Committee of Pharma Foods International Co. Ltd.
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 | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 08 | 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 | 01 | Month | 25 | Day |
Last modified on
| 2017 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029716
| Research Plan | |
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| 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 |
