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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033427
Receipt No. 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 2019/09/24

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email 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 No longer recruiting
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 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038112

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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