UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effect of oral supplementation using gamma-aminobutyric acid (GABA) and whey protein on muscle hypertrophy in men
Title of the study (Brief title)	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	Maya Sakashita
Organization	Pharma Foods International Co., Ltd.
Division name	Research and Development Department
Address	1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL	075-394-8605
Email	m-sakashita@pharmafoods.co.jp

Public contact
Name of contact person	Maya Sakashita
Organization	Pharma Foods International Co., Ltd.
Division name	Research and Development Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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