UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A exploratory study for the effects of antioxidant form of coenzyme Q10 (ubiquinol)
Title of the study (Brief title)	A exploratory study for the effects of antioxidant form of coenzyme Q10(ubiquinol)
Region	Japan

Condition
Condition	Subjects with tendency of constipation or diarrhea
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of antioxidant form of coenzyme Q10 for intestinal environment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)The change of defecation and fecal form 2)QOL 3)Cognitive function These are evaluate in baseline, 12 weeks, and 24 weeks after intervention
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	Treatment
Type of intervention	Food
Interventions/Control_1	antioxidant form of coenzyme Q10 (Ubiquinol) 50mg 3 capsuls (150mg) 1 time a day A group for 24 weeks, B group for 12 weeks
Interventions/Control_2	placebo capsule 3 capsuls1 time a day B group for 12 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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The subject are over 60 years old with tendency of constipation or diarrhea
Key exclusion criteria	1) Patients who have allergic to test food 1) Patients who have serious complications 2) Pregnant 3) Others
Target sample size	50

Research contact person
Name of lead principal investigator	Sho Suzuki
Organization	Yuri-Kumiai General Hospital
Division name	Department of Gastroenterology
Address	38, Kawaguchiazayago, Yurihonjoshi, Akita, Japan
TEL	0184-27-1200
Email	s.sho.salubriter.mail@gmail.com

Public contact
Name of contact person	Sho Suzuki
Organization	Yuri-Kumiai General Hospital
Division name	Department of Gastroenterology
Address	38, Kawaguchiazayago, Yurihonjoshi, Akita, Japan
TEL	0184-27-1200
Homepage URL
Email	s.sho.salubriter.mail@gmail.com

Sponsor
Institute	Yuri-Kumiai General Hospital
Institute
Department

Funding Source
Organization	KANEKA Coporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 09 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 09 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2017 Year 07 Month 08 Day
Date of closure to data entry	2017 Year 07 Month 30 Day
Date trial data considered complete	2017 Year 07 Month 30 Day
Date analysis concluded	2017 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 24 Day
Last modified on	2019 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022067