UMIN-CTR Clinical Trial

Basic information
Public title	Study of the blood glucose level reduction effects by ingestion of botanical extract-containing foods.
Acronym	Study of the blood glucose level reduction effects.
Scientific Title	The verification study to evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods in healthy adults with a higher fasting blood glucose level.
Scientific Title:Acronym	The verification study to evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fasting blood glucose level
Key secondary outcomes	Postprandial blood glucose level, Adiponectin, Weight, Uric acid, HbA1c

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	12-week intake of the test food
Interventions/Control_2	12-week intake of the placebo food
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy males and females from 20 to 64 years of age 2) Fasting blood glucose level from 90 mg/dL to 125 mg/dL
Key exclusion criteria	1) Subjects who have a habit of ingesting botanical extract-containing food. 2) Subjects having possibilities for emerging allergy related to the study. 3) Subjects who routinely take foods or medicines affecting the test result. 4) Subjects who have a disease requiring regular medication. 5) Subjects who are under treatment or have a history of serious disease (e.g. pancreatic disease, endocrine disease, liver disease, gastrectomy, kidney disease, heart disease or cancer). 6) Ineligible subjects with abnormal laboratory value or cardiopulmonary function. 7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. 8) Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work and overseas. 9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. 10) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period. 11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. 12) Subjects judged as unsuitable for the study by the investigator for other reasons.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Fujiwara
Organization	JAPAN TABLET CORPORATION
Division name	Sales department
Zip code	611-0041
Address	149-1, Megawa, Makishima-cho, Uji-shi, Kyoto
TEL	0774-20-5885
Email	makoto-fujiwara@j-tab.com

Public contact
Name of contact person	1st name Kaori Middle name Last name Yoshimura
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.ishida@ttc-tokyo.co.jp

Sponsor
Institute	JAPAN TABLET CORPORATION
Institute
Department

Funding Source
Organization	Lion Corporation
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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguro-ku, Tokyo
Tel	03-6452-2712
Email	saito876@eps.co.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	2020 Year 10 Month 05 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	No longer recruiting
Date of protocol fixation	2020 Year 09 Month 24 Day
Date of IRB	2020 Year 09 Month 24 Day
Anticipated trial start date	2020 Year 10 Month 08 Day
Last follow-up date	2021 Year 02 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 05 Day
Last modified on	2020 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047942

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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