UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042007 |
|---|---|
| Receipt number | R000047942 |
| Scientific Title | The verification study to evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods in healthy adults with a higher fasting blood glucose level. |
| Date of disclosure of the study information | 2020/10/05 |
| Last modified on | 2021/12/23 11:37:05 |
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Basic information
Public title
Study of the blood glucose level reduction effects by ingestion of botanical extract-containing foods.
Acronym
Study of the blood glucose level reduction effects.
Scientific Title
The verification study to evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods in healthy adults with a higher fasting blood glucose level.
Scientific Title:Acronym
The verification study to evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods.
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fasting blood glucose level
Key secondary outcomes
Postprandial blood glucose level, Adiponectin, Weight, Uric acid, HbA1c
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
12-week intake of the test food
Interventions/Control_2
12-week intake of the placebo food
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 from 20 to 64 years of age
2) Fasting blood glucose level from 90 mg/dL to 125 mg/dL
Key exclusion criteria
1) Subjects who have a habit of ingesting botanical extract-containing food.
2) Subjects having possibilities for emerging allergy related to the study.
3) Subjects who routinely take foods or medicines affecting the test result.
4) Subjects who have a disease requiring regular medication.
5) Subjects who are under treatment or have a history of serious disease (e.g. pancreatic disease, endocrine disease, liver disease, gastrectomy, kidney disease, heart disease or cancer).
6) Ineligible subjects with abnormal laboratory value or cardiopulmonary function.
7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
8) Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work and overseas.
9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
10) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
12) Subjects judged as unsuitable for the study by the investigator for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Fujiwara |
Organization
JAPAN TABLET CORPORATION
Division name
Sales department
Zip code
611-0041
Address
149-1, Megawa, Makishima-cho, Uji-shi, Kyoto
TEL
0774-20-5885
makoto-fujiwara@j-tab.com
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yoshimura |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
k.ishida@ttc-tokyo.co.jp
Sponsor or person
Institute
JAPAN TABLET CORPORATION
Institute
Department
Personal name
Funding Source
Organization
Lion Corporation
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
saito876@eps.co.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 05 | 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
| 2020 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 05 | 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 | 10 | Month | 05 | Day |
Last modified on
| 2021 | 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=R000047942
