UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032233
Receipt number 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 15:12:35

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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 or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



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

Value
https://center6.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