UMIN-CTR Clinical Trial

Basic information
Public title	Ubiquinol for women
Acronym	QH for women
Scientific Title	The effects of ubiquinol intake for women's health: a pilot study by comparing two periods
Scientific Title:Acronym	Women's ubiquinol in pilot study
Region	Japan

Condition
Condition	nothing
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of ubiquinol intake for women's whole health
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Female hormone secretion
Key secondary outcomes	basal body temperature, menstrual cycle, menstrual symptoms, menopausal symptoms, serum ubiquinol level, salivary coenzyme Q10 level, sleep condition, eating habits / eating behavior

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	Prevention
Type of intervention	Food
Interventions/Control_1	Participants consume 150 mg of ubiquinol daily for 3 cycles of menstruation.
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	50 years-old >
Gender	Female
Key inclusion criteria	(1) Women who work in medical and welfare facilities in Ehime Prefecture. (2) Between 20 and 50 years old, and before menopause. (3) Applicants who understand well the purpose and contents of this examination.Additionaly, who can agree to participate in this examination in writing.
Key exclusion criteria	(1) Have allergy against the test food. (2) Pregnant or nursing. (3) Who have participated in other clinical trials within 3 months. (4) Who daily consume supplements or foods containing coenzyme Q10. (5) Others who are judged to be ineligible by the investigator and co-workers.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Takayo Middle name Last name Sakiyama
Organization	Ehime University Graduate School of Medicine
Division name	Department of Fundamental and Clinical Nursing
Zip code	791-0295
Address	Shitsukawa, Toon, Ehime
TEL	089-960-5408
Email	sakiyama.takayo.xk@ehime-u.ac.jp

Public contact
Name of contact person	1st name TETSU Middle name Last name KINOSHITA
Organization	Institute of Community Life Sciences Co., Ltd.
Division name	Institute of Social Epidemiology
Zip code	791-02343
Address	1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL	089-904-7811
Homepage URL
Email	tetsu.prospective@gmail.com

Sponsor
Institute	Department of Fundamental and Clinical Nursing, Ehime University Graduate School of Medicine
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	IRB of Ehime University
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	2020 Year 03 Month 05 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	115
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	2020 Year 01 Month 27 Day
Date of IRB	2020 Year 01 Month 27 Day
Anticipated trial start date	2020 Year 03 Month 05 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 05 Day
Last modified on	2022 Year 03 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045291