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
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
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
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
