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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000038956
Receipt No. R000044134
Scientific Title A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Date of disclosure of the study information 2020/01/05
Last modified on 2020/08/21

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Basic information
Public title A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Acronym A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride
Scientific Title A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Scientific Title:Acronym A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride
Region
Japan

Condition
Condition No (include borderline diabetes)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of plant extract on postprandial blood glucose and serum triglyceride
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose AUC and Serum triglyceride AUC
Key secondary outcomes

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 Treatment
Type of intervention
Food
Interventions/Control_1 Powder containing plant extract, 1 sachet per serving
Interventions/Control_2 Powder not containing plant extract, 1 sachet per serving
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 year-old.
(2) Subjects who have enough information about its objective and details, can make self-judgment and voluntarily give written informed consent before they agree to participate.
(3) Subjects who can obey the directions of the investigators.
Key exclusion criteria (1) Subjects whose fasting blood glucose level is 126 mg/dL and over or two-hour blood glucose level after 75 g glucose loading is 200 mg/dL and over and/or who have been diagnosed with diabetes.
(2) Subjects whose fasting serum triglyceride level is 45 mg/dL or less and 150 mg/dL or over, or casual serum triglyceride level is 650 mg/dL and over.
(3) Subjects who contract or are under treatment for serious diseases (e.g., diabetes, liver disease, kidney disease, digestive system disease, heart disease, respiratory disease, peripheral vascular disorder, etc.).
(4) Subjects who use oral medication affecting blood glucose or lipid metabolism.
(5) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses, Foods with Functional Claims) affecting blood glucose or lipid metabolism.
(6) Subjects with abnormal parameters in liver and/or kidney function.
(7) Subjects who have a history of digestive disease surgery.
(8) Subjects with a disease that may have an influence on this study currently under treatment.
(9) Subjects who have declared an allergic reaction to test foods, or loading foods.
(10) Subjects with anemia or who have difficulty with self blood collection.
(11) Subjects who play high intensity sports and/or are on a diet.
(12) Subjects with irregular life patterns.
(13) Subjects who use medicines (including OTC and/or prescribed medications) continuously.
(14) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement.
(15) Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating.
(16) Subjects who are planning to participate in other clinical studies.
(17) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Shinichiro
Middle name
Last name Takashima
Organization TOYO SHINYAKU Co., Ltd.
Division name Clinical and analytical research center
Zip code 841-0005
Address 7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
TEL 0942-81-3555
Email takashimas@toyoshinyaku.co.jp

Public contact
Name of contact person
1st name Nobutaka
Middle name
Last name Kusaba
Organization TOYO SHINYAKU Co., Ltd.
Division name Clinical and analytical research center
Zip code 841-0005
Address 7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
TEL 0942-81-3555
Homepage URL
Email gakujutsu@toyoshinyaku.co.jp

Sponsor
Institute TOYO SHINYAKU Co., Ltd.
Institute
Department

Funding Source
Organization TOYO SHINYAKU 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 Miura Clinic, Medical Corporation Kanonkai IRB
Address 9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
Tel 06-6135-5200
Email mterashima@miura-cl.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 01 Month 05 Day

Related information
URL releasing protocol http://www.pieronline.jp/content/article/0386-3603/48060/1065
Publication of results Published

Result
URL related to results and publications http://www.pieronline.jp/content/article/0386-3603/48060/1065
Number of participants that the trial has enrolled 20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 06 Month 30 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2019 Year 10 Month 30 Day
Date of IRB
2019 Year 11 Month 21 Day
Anticipated trial start date
2020 Year 01 Month 06 Day
Last follow-up date
2020 Year 03 Month 10 Day
Date of closure to data entry
2020 Year 03 Month 12 Day
Date trial data considered complete
2020 Year 03 Month 13 Day
Date analysis concluded
2020 Year 04 Month 10 Day

Other
Other related information

Management information
Registered date
2019 Year 12 Month 23 Day
Last modified on
2020 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044134

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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