UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the effect of Nihonyamaninjin leaf on postprandial hyperglycemia and blood pressure-lowering- A randomized, double-blind, placebo-controlled -
Title of the study (Brief title)	A study on the effect of Nihonyamaninjin leaf on postprandial hyperglycemia and blood pressure-lowering
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of Nihonyamaninjin leaf on postprandial hyperglycemia and blood pressure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Postprandial plasma glucose levels and systolic blood pressure and diastolic blood pressure
Key secondary outcomes	fasting plasma glucose

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	Prevention
Type of intervention	Food
Interventions/Control_1	Intake test sample for 12 weeks/ single intake
Interventions/Control_2	Intake placebo for 12 weeks/ single intake
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	30 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects whose fasting blood glucose levels are less than 126 mg/dL or 2h-OGTT are less than 199 mg/dL. 2.Subjects with normal,high-normal,and stage 1 hypertention.
Key exclusion criteria	1. Subjects with food allergies 2. Subjects who are pregnant or lactating 3. Subjects who consume medicinal product which may influence the outcome of the study 4.Subjects who consume food which may influence the outcome of the study 5. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size	50

Research contact person
Name of lead principal investigator	Masatomo Najima
Organization	Japan clinical trial association
Division name	N.A.
Address	8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL	03-6457-4666
Email	info@yakujihou.org

Public contact
Name of contact person	Hirohisa Kojima
Organization	Japan clinical trial association
Division name	N.A.
Address	8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL	03-6457-4666
Homepage URL
Email	info@yakujihou.org

Sponsor
Institute	Japan clinical trial association
Institute
Department

Funding Source
Organization	Meigen Inc.
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	2017 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 27 Day
Anticipated trial start date	2017 Year 04 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 05 Month 01 Day
Last modified on	2018 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031152