UMIN-CTR Clinical Trial

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

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The Brief Job Stress Questionnaire
Japanese version of ESS

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

TTC Co., Ltd

Institute

Department

Personal name

Organization

KANEKA CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

07

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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