UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on efficacy of functional peptide-containing drink
Title of the study (Brief title)	A study on efficacy of functional peptide-containing drink
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy of taking functional peptide-containing drink for four weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stress reaction before and after the trial by POMS and the brief job stress questionnaire
Key secondary outcomes	Physical activity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The functional peptide drink is taken every day for four weeks.
Interventions/Control_2
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 and Female
Key inclusion criteria	Subjects who can make self-judgment and agree to participate this trial.
Key exclusion criteria	1) Subjects who have continuous medical treatment. 2) Subjects who are pregnant or have possibility to become pregnant or planning to become pregnant during the study or breast-feeding woman. 3) Subjects who are contracting kidney disease. 4) Subjects who have allergic reaction to food. 5) Subjects who are judged as unsuitable for the study by this study responsibility physician for other reasons.
Target sample size	200

Research contact person
Name of lead principal investigator	Norihito Murayama
Organization	Suntory Global Innovation Center Ltd.
Division name	Innovation Development Department
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284 Japan
TEL	050-3182-0588
Email	Norihito_Murayama@suntory.co.jp

Public contact
Name of contact person	Jiro Takano
Organization	Suntory Global Innovation Center Ltd.
Division name	Innovation Development Department
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0598
Homepage URL
Email	Jiro_Takano@suntory.co.jp

Sponsor
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Division of Psychosomatic Medicine, Teikyo University Hospital, Teikyo University School of Medicine
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 05 Day
Anticipated trial start date	2016 Year 02 Month 15 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	2016 Year 02 Month 10 Day
Last modified on	2018 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024186