UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039414
Receipt number R000044937
Scientific Title The verification for the improvement of the function of glucose metabolism and safety of the proanthocianidins derived from Acacia Bark in healthy Japanese adult subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2020/02/06
Last modified on 2021/12/20 12:14:11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The verification study for the fasting blood glucose reduction effects

Acronym

The verification study for the fasting blood glucose reduction effects

Scientific Title

The verification for the improvement of the function of glucose metabolism and safety of the proanthocianidins derived from Acacia Bark in healthy Japanese adult subjects: a randomized, double-blind, placebo-controlled, parallel-group trial

Scientific Title:Acronym

The verification for the improvement of the function of glucose metabolism and safety of the proanthocianidins derived from Acacia Bark in healthy Japanese adult subjects

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 suppressive effects on the elevation of postprandial blood glucose and glucose absorption with the intake of the test food. In addition, to verify the reduction effects on fasting blood glucose and the safety of long-term intake of the test food for 12 weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. The measured value of fasting blood glucose level at 12 weeks after the start of test-food consumption (12w)

Key secondary outcomes

1. The ratio of the number of subjects who are less than 110 mg/dL in fasting blood glucose level at 12w

2. The measured value of fasting blood glucose level at eight weeks after the start of test-food consumption (8w)

3. The measured value of fasting blood glucose level at four weeks after the start of test-food consumption (4w)

4. The change values of fasting blood glucose levels between at the examination before start of test-food consumption and at 4w, 8w and 12w

5. IAUC0-30, IAUC0-60, IAUC0-90, IAUC0-120 and Cmax at the examination before test-food consumption (with glucose load)

6. The measured values of blood glucose levels at 30, 60, 90 and 120 minutes after glucose load of the examination before test-food consumption (with glucose load)

7. The change values of blood glucose levels before glucose load and at 30, 60, 90 and 120 minutes after glucose load of the examination before test-food consumption (with glucose load)

8-1. The measured values of hemoglobin A1c (HbA1c: NGSP) level at 12w
8-2. The change values of hemoglobin A1c (HbA1c: NGSP) level between at the examination before start of test-food consumption and at 12w


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Tablet containing proanthocianidins derived from Acacia Bark
Glucose load (the examination before test-food consumption): "Sato No Gohan" (200 g; retort cooked rice)
Administration:
1. During test-food consumption: Take six tablets with water without chewing before meals.
* If you forget to take the test food, take it as soon as you remember within the day.

2. The examination before test-food consumption: Take six tablets with water without chewing five minutes before glucose load.

Interventions/Control_2

Duration: 12 weeks
Test food: Placebo tablet
Glucose load (the examination before test-food consumption): "Sato No Gohan" (200 g; retort cooked rice)
Administration:
1. During test-food consumption: Take six tablets with water without chewing before meals.
* If you forget to take the test food, take it as soon as you remember within the day.

2. The examination before test-food consumption: Take six tablets with water without chewing five minutes before glucose load.

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

2. Subjects who have relatively high levels of blood glucose, or being anxious about or suffering their blood glucose

3. Subjects who are judged as eligible to participate in the study by the physician

4. Subjects who are between 110 mg/dL or more and 125 mg/dL or less in fasting blood glucose at screening (before test-food consumption)

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

5. Currently taking medicines (include herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, breast-feeding, and planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial

9. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

60


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

Acacia-No-Ki 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

2020 Year 02 Month 06 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

66

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

2020 Year 01 Month 24 Day

Date of IRB

2020 Year 01 Month 24 Day

Anticipated trial start date

2020 Year 02 Month 10 Day

Last follow-up date

2020 Year 10 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 06 Day

Last modified on

2021 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044937


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name