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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name