UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033427 |
|---|---|
| Receipt number | R000038112 |
| Scientific Title | Effects of consumption of the test food containing banaba extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2018/07/18 |
| Last modified on | 2019/12/23 09:02:17 |
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Basic information
Public title
Effects of consumption of the test food containing banaba extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
Effects of consumption of the test food containing banaba extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion
Scientific Title
Effects of consumption of the test food containing banaba extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Effects of consumption of the test food containing banaba extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food containing banaba extract for 8 weeks on the fasting blood glucose level in healthy Japanese subjects.
To identify the safety of excessive consumption of the test food for 4 weeks in healthy Japanese subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Fasting blood glucose level
* Measure the values at screening (before consumption) and 8 and 12 weeks after consumption and calculate the amount of change.
Key secondary outcomes
1. Hemoglobin A1c (HbA1c) level
2. Serum glycoalbumin level
3. Serum insulin level
4. Plasma pentosidine
5. Vascular age
6. Vascular age score
7. Value of Schirmer's test (right eye, left eye, the average in both eyes, dominant eye, and non-dominant eye)
*1-7 Measure the values at screening (before consumption) and 8 and 12 weeks after consumption and calculate the amount of change.
*5,6 Measure the items by Medical Analyzer.
*7 Measure the item by Schirmer tear test strips.
<Safety evaluation items>
1. Physical examination
2. Urinalysis
3. Blood test
*1-3 Measure the values at 8 and 12 weeks after consumption and calculate the amount of change.
*2 Measure the values at 8 and 12 weeks after consumption.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test material: Tablet containing banaba extract
[from the starting date to intake through the examination at 8 weeks after consumption]
Dose: Take 2 tablets per day
Administration: Take 2 tablets with water or warm water after breakfast
[from the examination at 8 weeks after consumption through the examination at 12 weeks after consumption]
Dose: Take 10 tablets per day
Administration: Take 10 tablets any time during the day with water or warm water
* If you forget to take tablets, take these as soon as you remember within the day.
Interventions/Control_2
Duration: 12 weeks
Test material: Placebo tablet
<from the starting date to intake through the examination at 8 weeks after consumption>
Dose: Take 2 tablets per day
Administration: Take 2 tablets with water or warm water after breakfast
<from the examination at 8 weeks after consumption through the examination at 12 weeks after consumption>
Dose: Take 10 tablets per day
Administration: Take 10 tablets any time during the day with water or warm water
* If you forget to take tablets, take these as soon as you remember within the day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adult subjects who are anxious in blood glucose level
2. Subjects who are judged as eligible to participate in the study by the physician
3. Within the subjects who met the 1st and 2nd inclusion criteria, subjects between 110 mg/dL or more and 125 mg/dL or less in fasting blood glucose at screening (before consumption)
4. When a number of subjects who passed the inclusion criteria are below the sample size, select those whose fasting blood glucose levels are in a relatively high normal range (less than 110 mg/dL)
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction
2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
*Particularly taking food/beverage effective in lowering blood sugar in daily
4. Subjects who are currently taking medications (including herbal medicines) and supplement
*Particularly taking antihypertensive drugs in daily
5. Subjects who are allergic to medicines and/or the test food related products
6. Subjects who are pregnant, breast-feeding, or planning to become pregnant
7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
8. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
TOKIWA PHYTOCHEMICAL Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
info@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 18 | 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
32
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
| 2018 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 18 | Day |
Last modified on
| 2019 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038112
