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 |
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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
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
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
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
