UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044429
Receipt number R000050396
Scientific Title Effect of the test food containing plant extract on blood glucose -A randomized, double-blind, placebo-controlled, parallel-group study-
Date of disclosure of the study information 2021/06/18
Last modified on 2021/12/06 10:28:03

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Basic information

Public title

Effect of the test food containing plant extract on blood glucose
-A randomized, double-blind, placebo-controlled, parallel-group study-

Acronym

Effect of the test food containing plant extract on blood glucose

Scientific Title

Effect of the test food containing plant extract on blood glucose
-A randomized, double-blind, placebo-controlled, parallel-group study-

Scientific Title:Acronym

Effect of the test food containing plant extract on blood glucose

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of the test food on blood glucose

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HbA1c

Key secondary outcomes

Fasting blood glucose level, Blood insulin level, HOMA-IR, 1,5-AG, Body weight, BMI, Triglycerides


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

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of the test food for 12 weeks (6 tablets/day)

Interventions/Control_2

Intake of the placebo food for 12 weeks (6 tablets/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

65 years-old >

Gender

Male and Female

Key inclusion criteria

1)Healthy males and females aged 20 to 64 years
2)Subjects whose fasting blood glucose levels are less than 125 mg/dL and HbA1c are 5.6% to 6.4%
3)Subjects who take 3 meals a day
4)Subjects who don't habitually take much alcohol
5)Subjects who have understood the purpose and contents of the study and agree to participate by signing the written informed consent
6)Subjects who are not diagnosed disease by the doctor in charge

Key exclusion criteria

1)Subjects who are or have a history of diabetes
2)Subjects who habitually take medecine which may affect blood glucose level
3)Subjects who can't stop taking supplements which may affect blood glucose level
4)Subjects who have allergy to the test food
5)Subjects who have kidney disease, liver disease, heart disease, respiratory disease, endocrine disease, or other metabolic disease
6)Subjects who have chronic disease and habitually take medecine
7)Subjects who have digestive disease or a history of digestive surgery
8)Subjects who have severe diarrehea 7 days before the screening tests
9)Subjects who are considered as an inappropriate candidate based on the screening tests by the doctor in charge
10)Subjects who are diagnosed anemia
11)Subjects who donated blood of over 200 mL in the past 1 month or over 400 mL in the past 3 months
12)Subjects who are or have a history of alcoholism or drug addict
13)Shift worker or midnight shift worker
14)Subjects who are planning to participate in other clinical study during the study period or have participated in the past 1 month
15)Subjects who are pregnant, lactating, or planning to get pregnant
16)Subjects who are considered as an inappropriate candidate for other reasons by the doctor in charge

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yoshitaka
Middle name
Last name Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code

103-0001

Address

Kyodo Bldg. #201, 13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

TEL

03-5641-4133

Email

yiwama@well-sleep.jp


Public contact

Name of contact person

1st name Yoshika
Middle name
Last name Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

eigyou27@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

KOBAYASHI Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee of Nihonbashi Cardiology Clinic

Address

Kyodo Bldg. #201, 13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

Tel

03-5641-4133

Email

niho-jimucho@well-sleep.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

日本橋循環器科クリニック


Other administrative information

Date of disclosure of the study information

2021 Year 06 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


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 05 Month 14 Day

Date of IRB

2021 Year 05 Month 26 Day

Anticipated trial start date

2021 Year 06 Month 19 Day

Last follow-up date

2021 Year 11 Month 07 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 06 Month 04 Day

Last modified on

2021 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050396


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name