UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect of fasting blood glucose level by ingestion of botanical ingredient-containing foods in adult males and females with a higher fasting blood glucose.
Acronym	A study to evaluate the effect of fasting blood glucose level by ingestion of botanical ingredient-containing foods.
Scientific Title	A study to evaluate the effect of fasting blood glucose level by ingestion of botanical ingredient-containing foods in adult males and females with a higher fasting blood glucose.
Scientific Title:Acronym	A study to evaluate the effect of fasting blood glucose level by ingestion of botanical ingredient-containing foods.
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of fasting blood glucose level by ingestion of botanical ingredient-containing food
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fasting blood glucose level
Key secondary outcomes	HbA1c,Insulin

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	Ingestion of botanical ingredient-containing food for 12 consecutive weeks.
Interventions/Control_2	Intake of a placebo for 12 consecutive weeks
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Males and females from 20 to 64 years of age (2)Fasting blood glucose level are ranged from 90 mg/dL to less than 126 mg/dL
Key exclusion criteria	(1)Subjects who eat botanical ingredient-containing food 3 times per week. (2)Subjects who routinely take foods or medicines affecting the test result (3)Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required (4)Subjects who have under treatment or a history of serious disease (e.g., diabetes, or liver disease, kidney disease, or heart disease) (5)Subjects having possibilities for emerging allergy related to the study. (6)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (7)Subjects who have participated in other clinical study within the last one month prior to the current study (8)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (9)Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period. (10)Subjects who are judged unfit to enroll in this trial by the investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuyoshi Oishi
Organization	OCHAMURA,Inc.
Division name	Business Management Department
Zip code
Address	1069, Murooka, Yame-shi, Fukuoka
TEL	0943-24-0001
Email	katsuyoshi@ochamura.jp

Public contact
Name of contact person	1st name Middle name Last name Eri Yamazaki
Organization	TTC Co.,Ltd
Division name	Clinical Research Planning Department
Zip code
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	e.yamazaki@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd
Institute
Department

Funding Source
Organization	OCHAMURA,Inc.
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
Address
Tel
Email

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 10 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 05 Month 10 Day
Date of IRB	2018 Year 05 Month 10 Day
Anticipated trial start date	2018 Year 05 Month 31 Day
Last follow-up date	2018 Year 10 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 30 Day
Last modified on	2019 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037388