UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043552 |
|---|---|
| Receipt number | R000049739 |
| Scientific Title | Study of the effects on time-dependent change of blood glucose level by mulberry leaf green juice and baby oligo intake. |
| Date of disclosure of the study information | 2021/03/08 |
| Last modified on | 2021/05/10 11:43:46 |
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Basic information
Public title
Study of the effects on time-dependent change of blood glucose level by mulberry leaf green juice and baby oligo intake.
Acronym
Study of the effects on time-dependent change of blood glucose level by mulberry leaf green juice and baby oligo intake.
Scientific Title
Study of the effects on time-dependent change of blood glucose level by mulberry leaf green juice and baby oligo intake.
Scientific Title:Acronym
Study of the effects on time-dependent change of blood glucose level by mulberry leaf green juice and baby oligo intake.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the time-dependent change of blood glucose level when single intake of mulberry leaf green juice and baby oligo etc. are taken by Japanese men and women aged 20 to 50 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course of blood glucose concentration changes before and after a single ingesting (delta AUC)
*Measure before ingestion and 15, 30, 60, 90, and 120 minutes after ingestion.
Key secondary outcomes
Time course of blood glucose concentration changes before and after a single ingesting (delta C, delta Cmax, delta Tmax)
*Measure before ingestion and 15, 30, 60, 90, and 120 minutes after ingestion.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of Sato's Rice 100% Koshihikari rice 147 g
Washout for 1day or more
Intake of mulberry leaf green juice 8.0 g and then Sato's Rice 100% Koshihikari rice 147 g
Washout for 1day or more
Intake of mulberry leaf green juice 8.0 g
Washout for 1day or more
Intake of baby oligo 7.5 g
Interventions/Control_2
Intake of mulberry leaf green juice 8.0 g and then Sato's Rice 100% Koshihikari rice 147 g
Washout for 1day or more
Intake of mulberry leaf green juice 8.0 g
Washout for 1day or more
Intake of baby oligo 7.5 g
Washout for 1day or more
Intake of Sato's Rice 100% Koshihikari rice 147 g
Interventions/Control_3
Intake of mulberry leaf green juice 8.0 g
Washout for 1day or more
Intake of baby oligo 7.5 g
Washout for 1day or more
Intake of Sato's Rice 100% Koshihikari rice 147 g
Washout for 1day or more
Intake of mulberry leaf green juice 8.0 g and then Sato's Rice 100% Koshihikari rice 147 g
Interventions/Control_4
Intake of baby oligo 7.5 g
Washout for 1day or more
Intake of Sato's Rice 100% Koshihikari rice 147 g
Washout for 1day or more
Intake of mulberry leaf green juice 8.0 g and then Sato's Rice 100% Koshihikari rice 147 g
Washout for 1day or more
Intake of mulberry leaf green juice 8.0 g
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who are 20 years old or more and 50 years old or less
3.Persons whose BMI is 30.0 or less
4.Persons who do not have impaired glucose tolerance in the past year examination (As a result of medical checkup, persons with a fasting blood glucose of less than 110 mg / dL and HbA1c of less than 5.6%)
5.Persons who are not taking drugs such as anti-hypertensive agents
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who usually take a large amount of test food
4.Persons who usually take medicine, specified health food, healthy food
5.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement
6.Persons who are judged inappropriate for the exam by the principal investigator
7.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nozomi |
| Middle name | |
| Last name | Ando |
Organization
Natural Science Co.,Ltd.
Division name
Research and Development Department
Zip code
136-0073
Address
3-4-27 Kitasuna, Koto-ku, Tokyo 136-0073, JAPAN
TEL
03-5665-2311
ando@natural-s.jp
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Nishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
1050004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato
TEL
03-6809-2722
Homepage URL
nishikawa@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Natural Science 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato
Tel
03-6809-2722
soumu@hc-sys.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 | 03 | Month | 08 | 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
10
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 | 02 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | 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 | 03 | Month | 08 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049739
