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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044161
Receipt No. R000050429
Scientific Title A study evaluating the effect of botanical ingredient-containing food on glucose tolerance.
Date of disclosure of the study information 2021/06/01
Last modified on 2021/05/10

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Basic information
Public title A study evaluating the effect of botanical ingredient-containing food on glucose tolerance.
Acronym A study evaluating the effect of botanical ingredient-containing food on glucose tolerance.
Scientific Title A study evaluating the effect of botanical ingredient-containing food on glucose tolerance.
Scientific Title:Acronym A study evaluating the effect of botanical ingredient-containing food on glucose tolerance.
Region
Japan

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

Objectives
Narrative objectives1 The objective is to evaluate the effect of botanical ingredient-containing food on glucose tolerance by Oral Glucose Tolerance Test before and after repeated intake for 4 weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Area under the curve of blood glucose levels after Oral Glucose Tolerance Test
Incidence of adverse effects
Key secondary outcomes

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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Subjects take control food for 4 weeks. Before and after repeated intake, subjects take Oral Glucose Tolerance Test to measure blood glucose levels.
Interventions/Control_2 Subjects take test food 1 (containing botanical ingredient) for 4 weeks. Before and after repeated intake, subjects take Oral Glucose Tolerance Test to measure blood glucose levels.
Interventions/Control_3 Subjects take test food 2 (containing botanical ingredient) for 4 weeks. Before and after repeated intake, subjects take Oral Glucose Tolerance Test to measure blood glucose levels.
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 male and female subjects whose ages are 20 <= years old <65.
(2) Subjects who can visit the specified clinic on the scheduled day.
(3) Subjects who agree with the given description and express informed consent via telecommunication and written documents.
(4) Subjects whose blood glucose levels during the 75g OGTT are as follows;
A. equivalent to or higher than 157 mg/dl at 30 min.
B. equivalent to or higher than 130 mg/dl at 120 min., or whose Matsuda-index is lower than 4.3.
Key exclusion criteria (1) Systolic pressure <90 mmHg
(2) Subjects who are pregnant or lactating.
(3) Subjects who donated over 200ml blood components or whole blood within the past 4 weeks prior to the current study.
(4) Male who donated over 400ml whole blood within the past 12 weeks.
(5) Female who donated over 400ml whole blood within the past 16 weeks.
(6) Male whose blood was collected more than 1200 mL within the last 12 months when the amount of blood sampling in the current study is added.
(7) Female whose blood was collected over 800 mL within the last 12 months when the amount of blood sampling in the current study is added.
(8) Subjects who are participating in other clinical studies, or who finished clinical study within the last 4 weeks.
(9)Subjects
a) with disease on heart, liver, kidney or other organs complications. b) with a previous history of disease on circulatory organs. c) who are contracting diabetes. d) with test food allergy.
e) whose fasting blood glucose is equivalent to or higher than 140 mg/dL by a finger stick blood test.
(10) Subjects who have severe allergic reaction to drug medicine and food.
(11) Subjects with a previous history of feeling sick after blood sampling.
(12) Subjects who have difficulty in blood sampling from peripheral vein.
(13) Subjects who drink over 60 g of alcohol per day on average.
(14) Subjects who have irregular eating patterns.
(15) Subjects who work irregular shifts or at midnight.
(16) Subjects whose BMI is less than 18.5 or over 30.0 kg/m2.
(17) Subjects who are constantly taking certain drug medicine, or who are expecting taking it within the period of current study, or who have indispensable supplements, functional foods affecting the test results.
(18) Subjects who are contracting atopic dermatitis and/or allergy symptoms.
(19) Subjects who are contracting alcohol hypersensitivity.
(20) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 135

Research contact person
Name of lead principal investigator
1st name Takanori
Middle name
Last name Teramoto
Organization Suntory Global Innovation Center Ltd.
Division name Research Institute
Zip code 619-0238
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-6114
Email Takanori_Teramoto@suntory.co.jp

Public contact
Name of contact person
1st name Shinya
Middle name
Last name Fukizawa
Organization Suntory Global Innovation Center Ltd.
Division name Research Institute
Zip code 619-0238
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0595
Homepage URL
Email Shinya_Fukizawa@suntory.co.jp

Sponsor
Institute Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Corporation Kyoso-kai AMC Nishi-Umeda Clinic Ethics Review Committee
Address Maruit Nishi-Umeda Building 3F, 3-3-45 Umeda, Kita-ku, Osaka-shi, Osaka, Japan
Tel 06-4797-5660
Email jimukyoku@amc-clinc.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
2021 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 15 Day
Last follow-up date
2021 Year 11 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 10 Day
Last modified on
2021 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050429

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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