UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044161 |
|---|---|
| Receipt number | 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 | 2023/02/02 10:56:54 |
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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
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
Shinya_Fukizawa@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 23 | Day |
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
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050429
