UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study of the effect of test drink in subjects with postprandial hyperglycemia.
Title of the study (Brief title)	Examination of inhibitory effect of test drink on postprandial hyperglycemia.
Region	Japan

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

Objectives
Narrative objectives1	Examination of inhibitory effect of test drink containing plant extract on increase of postprandial blood glucose level.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postprandial blood glucose level, change of blood glucose level
Key secondary outcomes	Area under the curve of blood glucose level, maximum blood glucose level

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is 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 of water (single ingestion) - washout period - beverage containing plant extract (single ingestion)
Interventions/Control_2	Intake of beverage containing plant extract (single ingestion) - washout period - water (single ingestion)
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) Healthy males and females from 20 to 64 years of age 2) Blood glucose level at postprandial 30 minitues is ranged from 130 mg/dL to 199 mg/dL 3) Priority is given to those with a blood glucose peak of 30 minutes
Key exclusion criteria	1) Subjects who routinely use health food containing large amount of participating component or health food for diet 2) Subjects routinely taking medicine or health food which may influence glucose metabolism 3) Subjects who have body mass index (BMI) less than 18.5 kg/square meter or more than 30.0 kg/square meter 4) Subjects who have fasting blood glucose more than 126 mg/dL on preliminary examination 5) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) 6) Subjects having possibilities for emerging allergy related to the current study 7) Subjects who are under medication or having a history of serious diseases for which medication was required 8) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination 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) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 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	24

Research contact person
Name of lead principal investigator	Hirona Miura
Organization	Higashi shinjuku Clinic
Division name	Director
Address	1-11-3 Okubo Shinjuku-ku Tokyo
TEL	03-6233-8581
Email	koike@meiseikai-cl.com

Public contact
Name of contact person	Shinsuke Tsuji
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	non-disclosure
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	2018 Year 03 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 08 Day
Anticipated trial start date	2018 Year 03 Month 06 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	Published
URL releasing results
Results	Twenty - four adult men and women with high blood glucose levels 30 minutes after a meal were given a single drink containing a plant extract and water, and the effect of suppressing an increase in postprandial blood glucose level was examined. As a result, no significant difference was found between the botanical extract-containing beverage and the water in both the primary evaluation item and the secondary evaluation item. Regarding safety, there were no adverse events in any of the subjects during this study, and there were no problems with safety.
Other related information

Management information
Registered date	2018 Year 03 Month 05 Day
Last modified on	2018 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036073