UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial to reduce stress
Title of the study (Brief title)	Randomized controlled trial to reduce stress
Region	Japan

Condition
Condition	NA
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy of implementation of self-help stress care program and taking functional peptide-containing drink for six weeks
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stress reaction, administered before and after the trial (6W); the Tension-Anxiety (TA), Depression (D), and Fatigue (F) subscales of the POMS
Key secondary outcomes	Somatosensory Amplification Scale , Medical Symptom Checklist, General Self Efficacy Scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Self-help stress care program and functional peptide drink for 6 weeks everyday
Interventions/Control_2	Self-help stress care program for 6 weeks everyday
Interventions/Control_3	Placebo program for 6 weeks everyday
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	1) Healthy males and females aged 20 years or more. 2) Subjects who can make self-judgment and agree to participate this trial.
Key exclusion criteria	1)Subjects who take 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 have allergic reaction to food. 4)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	90

Research contact person
Name of lead principal investigator	Keiichi Abe
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	050-3182-0433
Email	Keiichi_Abe@suntory.co.jp

Public contact
Name of contact person	Yuji Nonaka
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	050-3182-0587
Homepage URL
Email	Yuji_Nonaka@suntory.co.jp

Sponsor
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization	Suntory Global Innovation Center Ltd.
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 Faculty of Human Sciences, Musashino University
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 09 Month 05 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 09 Month 08 Day
Anticipated trial start date	2014 Year 09 Month 24 Day
Last follow-up date	2014 Year 11 Month 28 Day
Date of closure to data entry	2014 Year 12 Month 15 Day
Date trial data considered complete	2015 Year 01 Month 20 Day
Date analysis concluded	2015 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.facebook.com/wcpmglasgow/
Results	The self-help CCBT program reduced the subjective experience of tension-anxiety in workers. The addition of a supplement drink enhanced the effect of CCBT on fatigue, providing one possible approach to enhancement of such programs.
Other related information

Management information
Registered date	2016 Year 09 Month 02 Day
Last modified on	2016 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027527