UMIN-CTR Clinical Trial

Basic information
Public title	Study of the effects on time-dependent change of blood glucose level by mulberry leaf green juice and baby oligo intake.
Acronym	Study of the effects on time-dependent change of blood glucose level by mulberry leaf green juice and baby oligo intake.
Scientific Title	Study of the effects on time-dependent change of blood glucose level by mulberry leaf green juice and baby oligo intake.
Scientific Title:Acronym	Study of the effects on time-dependent change of blood glucose level by mulberry leaf green juice and baby oligo intake.
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the time-dependent change of blood glucose level when single intake of mulberry leaf green juice and baby oligo etc. are taken by Japanese men and women aged 20 to 50 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time course of blood glucose concentration changes before and after a single ingesting (delta AUC) *Measure before ingestion and 15, 30, 60, 90, and 120 minutes after ingestion.
Key secondary outcomes	Time course of blood glucose concentration changes before and after a single ingesting (delta C, delta Cmax, delta Tmax) *Measure before ingestion and 15, 30, 60, 90, and 120 minutes after ingestion.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of Sato's Rice 100% Koshihikari rice 147 g Washout for 1day or more Intake of mulberry leaf green juice 8.0 g and then Sato's Rice 100% Koshihikari rice 147 g Washout for 1day or more Intake of mulberry leaf green juice 8.0 g Washout for 1day or more Intake of baby oligo 7.5 g
Interventions/Control_2	Intake of mulberry leaf green juice 8.0 g and then Sato's Rice 100% Koshihikari rice 147 g Washout for 1day or more Intake of mulberry leaf green juice 8.0 g Washout for 1day or more Intake of baby oligo 7.5 g Washout for 1day or more Intake of Sato's Rice 100% Koshihikari rice 147 g
Interventions/Control_3	Intake of mulberry leaf green juice 8.0 g Washout for 1day or more Intake of baby oligo 7.5 g Washout for 1day or more Intake of Sato's Rice 100% Koshihikari rice 147 g Washout for 1day or more Intake of mulberry leaf green juice 8.0 g and then Sato's Rice 100% Koshihikari rice 147 g
Interventions/Control_4	Intake of baby oligo 7.5 g Washout for 1day or more Intake of Sato's Rice 100% Koshihikari rice 147 g Washout for 1day or more Intake of mulberry leaf green juice 8.0 g and then Sato's Rice 100% Koshihikari rice 147 g Washout for 1day or more Intake of mulberry leaf green juice 8.0 g
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	Male and Female
Key inclusion criteria	1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Healthy Japanese who are 20 years old or more and 50 years old or less 3.Persons whose BMI is 30.0 or less 4.Persons who do not have impaired glucose tolerance in the past year examination (As a result of medical checkup, persons with a fasting blood glucose of less than 110 mg / dL and HbA1c of less than 5.6%) 5.Persons who are not taking drugs such as anti-hypertensive agents
Key exclusion criteria	1.Persons who have chronic illness, receiving medication, have a serious disease history 2.Persons who are allergic to the test food 3.Persons who usually take a large amount of test food 4.Persons who usually take medicine, specified health food, healthy food 5.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement 6.Persons who are judged inappropriate for the exam by the principal investigator 7.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Nozomi Middle name Last name Ando
Organization	Natural Science Co.,Ltd.
Division name	Research and Development Department
Zip code	136-0073
Address	3-4-27 Kitasuna, Koto-ku, Tokyo 136-0073, JAPAN
TEL	03-5665-2311
Email	ando@natural-s.jp

Public contact
Name of contact person	1st name Kosei Middle name Last name Nishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	1050004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato
TEL	03-6809-2722
Homepage URL
Email	nishikawa@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization	Natural Science 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	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato
Tel	03-6809-2722
Email	soumu@hc-sys.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	2021 Year 03 Month 08 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	10
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	2021 Year 02 Month 22 Day
Date of IRB	2021 Year 02 Month 22 Day
Anticipated trial start date	2021 Year 03 Month 10 Day
Last follow-up date	2021 Year 03 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	2021 Year 03 Month 08 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049739