UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039508 |
|---|---|
| Receipt number | R000045057 |
| Scientific Title | A study for the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level. |
| Date of disclosure of the study information | 2021/04/16 |
| Last modified on | 2020/07/10 10:27:27 |
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Basic information
Public title
A study for the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level.
Acronym
A study for the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level.
Scientific Title
A study for the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level.
Scientific Title:Acronym
A study for the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the suppressive effect of mulberry leaf powder-containing foods on the elevation of postprandial blood glucose level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of blood glucose level
Key secondary outcomes
Fasting blood glucose level
Postprandial blood glucose level (30, 60, 90, 120 min)
maximum blood glucose level
Fasting blood insulin level
Postprandial blood insulin level (30, 60, 90, 120 min)
Base
Study type
Interventional
Study design
Basic design
Cross-over
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 test food (single ingestion)-washing out (7 days or more)-intake of placebo (single ingestion)
Interventions/Control_2
Intake of placebo (single ingestion)-washing out (7 days or more)-intake of test food (single ingestion)
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 64 years of age
(2) Blood glucose level at postprandial 30 minitues is ranged from 140 mg/dL to 199 mg/dL
Key exclusion criteria
(1) Subjects who have a habit of continuously ingesting mulberry (including mulberry tea).
(2) Subjects who routinely take foods or medicines affecting the test result.
(3) Subjects who have a disease requiring regular medication.
(4) Subjects who are under treatment or have a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease).
(5) Ineligible subjects with abnormal laboratory value or cardiopulmonary function.
(6) Subjects having possibilities for emerging allergy related to the study.
(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 judged as unsuitable for the study by the investigator for other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kojima |
Organization
Minato Pharmaceutical co., Ltd.
Division name
Sales department
Zip code
104-0061
Address
1-14-11, Ginza, Chuo-ku, Tokyo
TEL
03-3564-3710
kojima@minato-p.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
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
s.yamamichi@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Minato 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
Aisei Hospital Ueno Clinic Research Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel
03-6455-0880
t.saito@ttc-smo.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
| 2021 | Year | 04 | Month | 16 | 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 | 02 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 17 | 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 | 17 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045057
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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