UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of a plant powder on postprandial blood glucose level: a randomized, double-blind, placebo-controlled, cross-over trial.
Title of the study (Brief title)	Effect of a plant powder on postprandial blood glucose level
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of plant powder ingestion on postprandial blood glucose.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Postprandial blood glucose
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single oral intake of a plant poder
Interventions/Control_2	Single oral intake of placebo
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	18 years-old <=
Age-upper limit	25 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy person aged from 18 to 25 y.
Key exclusion criteria	1) Those receiving treatment (prescription of medicine by doctor) 2) Persons suffering from serious cardiovascular disorder, liver dysfunction, renal dysfunction, respiratory disorder, endocrine disorder, metabolic disorder, those with a history of these 3) Those who are likely to cause allergy related to the test meal
Target sample size	16

Research contact person
Name of lead principal investigator	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Address	1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL	+81-476-98-1001
Email	yssuzuki@juntendo.ac.jp

Public contact
Name of contact person	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Address	1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL	+81-476-98-1001
Homepage URL
Email	yssuzuki@juntendo.ac.jp

Sponsor
Institute	Juntendo University, Graduate School of Sport and Health Science
Institute
Department

Funding Source
Organization	Chiba Nosan Inc. Ltd.
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	順天堂大学さくらキャンパス(千葉県)

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 16 Day
Anticipated trial start date	2018 Year 01 Month 28 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	2018 Year 01 Month 15 Day
Last modified on	2018 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035183