UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032233
Receipt No. R000036759
Scientific Title A study to evaluate the effect of intake of Ubiquinol on the status of stress and sleep in adult workers.
Date of disclosure of the study information 2019/07/28
Last modified on 2018/12/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study to evaluate the effect of intake of Ubiquinol on the status of stress and sleep in adult workers.
Acronym A study to evaluate the effect of intake of Ubiquinol on the status of stress and sleep.
Scientific Title A study to evaluate the effect of intake of Ubiquinol on the status of stress and sleep in adult workers.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hideyuki Morikawa
Organization KANEKA CORPORATION
Division name Pharma & Supplemental Nutrition Solutions Vehicle, Supplemental Nutrition Devision
Zip code
Address 2-3-18, Nakanoshima, Kita-ku, Osaka
TEL 050-3133-7673
Email Hideyuki.Morikawa@kaneka.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saki Fukuchi
Organization TTC CO., LTD.
Division name Clinical Research Planning Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 04 Month 12 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.