UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049500
Receipt number R000056357
Scientific Title The verification of health promotion effects of ubiquinol (reduced formed coenzyme Q10) containing foods for community residents
Date of disclosure of the study information 2022/11/17
Last modified on 2025/03/25 09:46:38

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Basic information

Public title

The verification of the effects of "Q10 yogurt" on total health benefit.

Acronym

Q10 yogurt health examination

Scientific Title

The verification of health promotion effects of ubiquinol (reduced formed coenzyme Q10) containing foods for community residents

Scientific Title:Acronym

Q10 yogurt health examination

Region

Japan


Condition

Condition

Nothing

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects of consumption of ubiquinol containing foods on health promotion, and to contribute the health maintenance of community residents.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cognitive performance

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Consume the food or supplement containing 100mg ubiquinol.

Interventions/Control_2


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Those who can participate in the regular health examination.
(2) Those whose age at the time of informed consent is 20 and over.
(3) Those who can understand the purpose and the contents of this study, and can agree with participation by letter.

Key exclusion criteria

(1) The presence of allergic response to test foods.
(2) Pregnancy or beast-feeding.
(3) Those who participated in other clinical trials within three months.
(4) Those who consume coenzyme Q10 supplements routinely.
(3) In addition, those who were judged inadequate by the principal investigator.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Tetsu
Middle name
Last name Kinoshita

Organization

Institute of Community Life Sciences Co., Ltd.

Division name

Social Epidemiology Institute

Zip code

791-0243

Address

1383-2, Hirai-machi, Matsuyama, Ehime

TEL

089-904-7811

Email

tetsu.prospective@gmail.com


Public contact

Name of contact person

1st name Tetsu
Middle name
Last name Kinoshita

Organization

Institute of Community Life Sciences Co., Ltd.

Division name

Social Epidemiology Institute

Zip code

791-0243

Address

1383-2, Hirami-machi, Matsuyama, Ehime

TEL

089-904-7811

Homepage URL


Email

tetsu.prospective@gmail.com


Sponsor or person

Institute

Institute of Community Life Sciences 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

Ehime University Graduate School of Agriculture

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board (IRB) of Ehime University Hospital

Address

Shitsukawa, Toon, Ehime

Tel

0899605172

Email

rinri@m.ehime-u.ac.jp


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

2022 Year 11 Month 17 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

2022 Year 10 Month 24 Day

Date of IRB

2022 Year 10 Month 24 Day

Anticipated trial start date

2022 Year 11 Month 19 Day

Last follow-up date

2025 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 11 Month 15 Day

Last modified on

2025 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056357