UMIN-CTR Clinical Trial

Basic information
Public title	Effect of supplements containing malic acid and magnesium oxide on sleeping - a parallel randomized trial-.
Acronym	Effect of malic acid and magnesium oxide on sleeping.
Scientific Title	Effect of supplements containing malic acid and magnesium oxide on sleeping - a parallel randomized trial-.
Scientific Title:Acronym	Effect of malic acid and magnesium oxide on sleeping.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of supplements containing malic acid and magnesium oxide on sleeping of healthy Japanese.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Noise level during sleep
Key secondary outcomes	PSQI(Pittsburgh Sleep Quality Index) POMS States-Brief Form (Profile of Mood States-Brief Form Japanese Version) ESS(Epworth Sleepiness Scale)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Capsule containing malic acid and magnesium oxide 6 tablets/day, For the 28 days
Interventions/Control_2	Placebo capsule not containing magnesium malate, 6 tablets/day, For the 28 days
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)persons who is generally judged as healthy (2)persons who hindrance to sleep and snoring awareness
Key exclusion criteria	(1) persons who have changed their habitats to take supplements within past 4 weeks (2) persons who have been treated their illness or prevention in a clinic at their informed consent (3) persons with their medical histories as follows: serious diseases of sugar metabolism,lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (4) persons with the medical histories of alcoholism or drug dependence (5) persons who might be developed allergic reaction to foods. (6) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (7) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) within past 4 weeks (8) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (9) persons who will not be judged suitable to the participants by the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name koichiro Middle name Last name ohnuki
Organization	Kindai University
Division name	Faculty of Humanity-oriented Science and Engineering
Zip code	820-8555
Address	11-6, Kashiwanomori, Iizuka, Fukuoka, Fukuoka, JAPAN
TEL	0948-22-5655
Email	ohnuki@fuk.kindai.ac.jp

Public contact
Name of contact person	1st name koichiro Middle name Last name ohnuki
Organization	Kindai University
Division name	Faculty of Humanity-oriented Science and Engineering
Zip code	820-8555
Address	11-6, Kashiwanomori, Iizuka, Fukuoka, Fukuoka, JAPAN
TEL	0948-22-5655
Homepage URL
Email	ohnuki@fuk.kindai.ac.jp

Sponsor
Institute	Kindai University Department of Biological & Enviromental Chemistry Faculty of Human-Oriented Science and Engineering
Institute
Department

Funding Source
Organization	Kensho Co. Ltd.
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	Ethics Committee of University Faculty of Humanity-oriented Science and Engineering
Address	11-6, Kashiwanomori, Iizuka, Fukuoka, Fukuoka, JAPAN
Tel	0948-22-5655
Email	ohnuki@fuk.kindai.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	2019 Year 08 Month 03 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 06 Month 30 Day
Date of IRB	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 04 Day
Last follow-up date	2018 Year 08 Month 12 Day
Date of closure to data entry	2018 Year 08 Month 19 Day
Date trial data considered complete	2018 Year 08 Month 24 Day
Date analysis concluded	2018 Year 09 Month 08 Day

Other
Other related information

Management information
Registered date	2018 Year 07 Month 02 Day
Last modified on	2019 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037896