UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031596
Receipt No. R000036073
Scientific Title Pilot study of the effect of test drink in subjects with postprandial hyperglycemia.
Date of disclosure of the study information 2018/03/05
Last modified on 2018/09/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Pilot study of the effect of test drink in subjects with postprandial hyperglycemia.
Acronym Examination of inhibitory effect of test drink on postprandial hyperglycemia.
Scientific Title Pilot study of the effect of test drink in subjects with postprandial hyperglycemia.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirona Miura
Organization Higashi shinjuku Clinic
Division name Director
Zip code
Address 1-11-3 Okubo Shinjuku-ku Tokyo
TEL 03-6233-8581
Email koike@meiseikai-cl.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Tsuji
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 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)

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
2018 Year 03 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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 02 Month 08 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.