UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037920 |
|---|---|
| Receipt number | R000043222 |
| Scientific Title | Study for effect on blood glucose level change by ingestion of red clover extract |
| Date of disclosure of the study information | 2019/09/04 |
| Last modified on | 2020/04/08 09:38:19 |
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Basic information
Public title
Study for effect on blood glucose level change by ingestion of red clover extract
Acronym
Study for effect by ingestion of red clover extract
Scientific Title
Study for effect on blood glucose level change by ingestion of red clover extract
Scientific Title:Acronym
Study for effect by ingestion of red clover extract
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify inhibition effect on postprandial blood glucose level rise by a single ingesting of red clover extract and effect on fasting blood glucose level change after 8 weeks of continuous intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c 8 weeks after continuous intake
Time course of blood glucose concentration changes before and after a single ingesting(C,Cmax,Tmax,delta AUC)
*Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.
Key secondary outcomes
Time course of blood insulin concentration changes before and after a single ingesting(C,Cmax,Tmax,delta AUC)
*Measure at just before ingestion and 30, 60, 90, and 120 minutes after ingestion.
fasting blood glucose level 8 weeks after continuous intake
fasting blood insulin level 8 weeks after continuous intake
Physical examination (body height, weight, BMI)
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
Sugar load*1 at the time of screening and Sugar load after taking red clover extract 1.91g on the test day before intake. In addition, take red clover extract 1.91g every day for 8 weeks, once a day at dinner, immediately before meals or with meals.
*1: Sugar loading is performed by ingesting 200 mL of water in which 50 g of maltose is dissolved for 5 to 10 minutes.
Interventions/Control_2
Sugar load*2 at the time of screening and Sugar load after taking dextrin 1.91g on the test day before intake. In addition, take dextrin 1.91g every day for 8 weeks, once a day at dinner, immediately before meals or with meals.
*2: Sugar loading is performed by ingesting 200 mL of water in which 50 g of maltose is dissolved for 5 to 10 minutes.
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.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 over 20 years old and under 65 at the time of consent acquisition
3.Those whose BMI less than 25 at the time of screening
4.Those whose blood glucose concentration is less than 126 mg per dL at the time of screening
5.Those with occasional blood glucose levels of less than 200 mg per dL at screening
6.Those whose blood HbA1c is less than 6.5% at the time of screening
7.Those who apply to 6 and are top 40 of numerical value of HbA1c.
Key exclusion criteria
1.Those who have a chronic disease and are undergoing medication, those with a serious disease history
2.Those who are allergic to the test food
3.Those who regularly use medicines, specific insurance foods, health foods, etc. that may affect blood glucose levels
4.Those who have participated in other tests within the first month before the start of the exam, or who are planning to participate in other exams after this exam consent
5.Those who are judged ineligible at the discretion of the examining supervisor and research leader
6.Those who are breast-feeding, pregnant, and are planning or hoping pregnancy during the exam
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Saladcosmo 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-ku, Tokyo, JAPAN
Tel
03-6809-2722
kakehashi@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
| 2019 | Year | 09 | Month | 04 | 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
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 04 | Day |
Last modified on
| 2020 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043222
