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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025842
Receipt No. 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

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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
Email 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
Email m-sakashita@pharmafoods.co.jp

Sponsor
Institute Pharma Foods International Co., Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029716

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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