UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048040 |
|---|---|
| Receipt number | R000054753 |
| Scientific Title | A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism. |
| Date of disclosure of the study information | 2022/06/17 |
| Last modified on | 2023/06/20 09:25:51 |
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Basic information
Public title
A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Acronym
A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Scientific Title
A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Scientific Title:Acronym
A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
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 parameters of glucose metabolism after repeated intake for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
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 12 weeks. Before and after repeated intake, subjects take blood sampling.
Interventions/Control_2
Subjects take test food 1 (containing botanical ingredient) for 12 weeks. Before and after repeated intake, subjects take blood sampling.
Interventions/Control_3
Subjects take test food 2 (containing botanical ingredient) for 12 weeks. Before and after repeated intake, subjects take blood sampling.
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 written documents.
(4) Subjects whose HbA1c is equal to or more than 5.6 % and less than 6.5 %.
Key exclusion criteria
(1) Systolic pressure <90 mmHg
(2) pregnant or lactating.
(3) donated over 200ml blood components or whole blood within the past 4 weeks.
(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 more than 800 mL within the last 12 months when the amount of blood sampling in the current study is added.
(8) 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) contracting diabetes.
d) with test food allergy.
(10) Who have possibility to be diagnosed as diabetes; whose fasting blood glucose is equal to or more than 126 mg/dL, or whose blood glucose level during the 75g OGTT is equivalent to or more than 200 mg/dL at 120 min., or whose HbA1c is equal to or more than 6.5 %.
(11) with severe allergic reaction to drug medicine and food.
(12) with a previous history of feeling sick after blood sampling.
(13) Who have difficulty in blood sampling from peripheral vein.
(14) Who drink alcohol a lot (over 60 g of alcohol per day on average).
(15) Who have irregular eating patterns.
(16) Who work irregular shifts or at midnight.
(17) constantly taking certain drug medicine, or expecting taking it within the period of current study, or indispensable supplements, functional foods (including Food for Specified Health Uses) affecting the test results.
(18) whose BMI is less than 18.5 or equal to or more than 30.0 kg/m2.
(19) contracting atopic dermatitis and/or allergy symptoms.
(20) contracting alcohol hypersensitivity.
(21) 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 | Noriyuki |
| Middle name | |
| Last name | Kanzaki |
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
Noriyuki_Kanzaki@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
050-3182-6114
Homepage URL
Noriyuki_Kanzaki@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
The ethics committees of Yoga Allergy Clinic
Address
4-32-16, Yoga, Setagaya-ku, Tokyo, Japan
Tel
03-5491-4478
info@yg-allergy.com
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
| 2022 | Year | 06 | Month | 17 | 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
| 2022 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054753
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