UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the effect of the intake of fermented ginseng-containing food on stress
Title of the study (Brief title)	A study on the effect of the intake of fermented ginseng-containing food on stress
Region	Japan

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

Objectives
Narrative objectives1	This study aims to evaluate the improvement effects of ingestion of fermented ginseng-containing food for 8 consecutive weeks on stress, quality of the sleep, fatigue, and stress biomarkers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stress:POMS2-AS Sleep:AIS, PSQI-j
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food containing fermented ginseng for 8 consecutive weeks
Interventions/Control_2	Ingestion of placebo without fermented ginseng for 8 consecutive 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	30 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Male and female workers from 30 to 60 years old 2) POMS2-AS FI T score is 50 and more, and VA T score is 50 and less
Key exclusion criteria	1)Subjects who routinely use food or medicine containing of ginsenosides 2)Subjects who perform an act for the improvement of the fatigue, the quality of the sleep and stress 3)Subjects who wake after sleep onset for nocturia twice and more than twice a week 4)Night and day shift worker or manual laborer 5)Subjects who have a disease on treatment or are judged to that medical treatment are necessary by the doctor 6)Subjects who are under treatment or a history of sleep apnea syndrome or are strongly suspected of having sleep apnea syndrome 7)Subjects diagnosed with chronic fatigue syndrome 8)Subjects who were under treatment or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, or heart disease) 9)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires 10)Subjects having possibilities for emerging allergy related to the study 11)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 12)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 13)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 14)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	40

Research contact person
Name of lead principal investigator	Han Jong Pyo
Organization	Naturetech Co., Ltd.
Division name	R&D Center
Address	29-8, Yongjeong-Gil, Chopyeong-Myeon, Jincheon-Gun, Chungbuk, Korea 365-850
TEL	+82-43-530-7944
Email	pyobass@naturetech.co.kr

Public contact
Name of contact person	Etsushi Yamamoto
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	e.yamamoto@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Funding Source
Organization	Naturetech Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 08 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 23 Day
Anticipated trial start date	2016 Year 08 Month 06 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 06 Month 29 Day
Last modified on	2017 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026443