UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of intake of Ubiquinol on the status of stress and sleep in adult workers.
Title of the study (Brief title)	A study to evaluate the effect of intake of Ubiquinol on the status of stress and sleep.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of intake of Ubiquinol on the status of stress and sleep, safety for 8 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Brief Job Stress Questionnaire Japanese version of ESS
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 the test product for 8 weeks
Interventions/Control_2	Ingestion of the placebo for 8 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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy males and females from 30 to 64 years of age 2) Subjects who are targeted for 25% of high ranks in domain B stress of BJSQ in 1).
Key exclusion criteria	1) Subjects who are diagnosed melancholy by BDI-II. 2) Subjects who are 0mm as a result of VAS stress . 3) Subjects who routinely use food or medicine containing of Ubiquinol. 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) Those who can not carry out the procedures of various tests to be carried out during this study. 11) Subjects having possibilities for emerging allergy related to the study. 12) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. 13) 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. 14) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. 15) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	60

Research contact person
Name of lead principal investigator	Hideyuki Morikawa
Organization	KANEKA CORPORATION
Division name	Pharma & Supplemental Nutrition Solutions Vehicle, Supplemental Nutrition Devision
Address	2-3-18, Nakanoshima, Kita-ku, Osaka
TEL	050-3133-7673
Email	Hideyuki.Morikawa@kaneka.co.jp

Public contact
Name of contact person	Saki Fukuchi
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	s.fukuchi@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	KANEKA CORPORATION
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	2019 Year 07 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 12 Day
Anticipated trial start date	2018 Year 04 Month 14 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	2018 Year 04 Month 13 Day
Last modified on	2018 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036759