UMIN-CTR Clinical Trial

Basic information
Public title	The acute effects of Saji juice on postprandial glucose
Acronym	Saji clinical trial
Scientific Title	The acute effects of Saji on postprandial glucose
Scientific Title:Acronym	Saji clinical trial
Region	Japan

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

Objectives
Narrative objectives1	To investigate the postprandial lipemia and glycemic in Saji intake
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postprandial glycemia
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Saji juice 30mL / time
Interventions/Control_2	Placebo 30 mL / time
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 are generally considered to be healthy
Key exclusion criteria	(1) Persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (2) Persons who have changed their habitats to take supplements or to use cosmetics within past 4 weeks. (3) Persons who work in night shift or in day and night shift (4) Persons who have been treated their illness or prevention in a clinic at their informed consent (5) 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 (6) Persons with the medical histories of alcoholism or drug dependence (7) Persons who might be developed allergic reaction to foods. (8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (9) Persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10) Persons who will not be judged suitable to the participants by the investigator.
Target sample size	10

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, Kayanomori, Iizuka-shi, Fukuoka
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, Kayanomori, Iizuka-shi, Fukuoka
TEL	0948-22-5655
Homepage URL
Email	ohnuki@fuk.kindai.ac.jp

Sponsor
Institute	Faculty of humanity-oriented science and engineering ,Kindai University
Institute
Department

Funding Source
Organization	Finess Co. Ltd.,
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Faculty of Agriculture, Kyushu University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kindai University Faculty of Industrial Science and Technology Ethics Committee
Address	11-6 Kayanomori, Iizuka City, Fukuoka Prefecture
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	近畿大学 産業理工学部 生物環境化学科 食品機能学研究室

Other administrative information
Date of disclosure of the study information	2022 Year 10 Month 27 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	Preinitiation
Date of protocol fixation	2021 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 16 Day
Last follow-up date	2021 Year 10 Month 27 Day
Date of closure to data entry	2021 Year 11 Month 10 Day
Date trial data considered complete	2021 Year 11 Month 27 Day
Date analysis concluded	2021 Year 12 Month 27 Day

Other
Other related information

Management information
Registered date	2021 Year 09 Month 30 Day
Last modified on	2021 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052081