UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048002 |
|---|---|
| Receipt number | R000054718 |
| Scientific Title | A randomized, double-blind, placebo-controlled, crossover study on the suppressive effect of the peptide on postprandial blood glucose level |
| Date of disclosure of the study information | 2022/06/17 |
| Last modified on | 2022/12/28 15:58:37 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, crossover study on the suppressive effect of the peptide on postprandial blood glucose level
Acronym
Suppressive effect of the peptide on postprandial blood glucose level
Scientific Title
A randomized, double-blind, placebo-controlled, crossover study on the suppressive effect of the peptide on postprandial blood glucose level
Scientific Title:Acronym
Suppressive effect of the peptide on postprandial blood glucose level
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the suppressive effect of the peptide on 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 levels (0-120 min)
Key secondary outcomes
Postprandial blood glucose levels (each time point), Cmax of blood glucose level, Tmax of blood glucose level, insulin levels (each time point), insulinogenic index
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
A single intake of the peptide food
Interventions/Control_2
A single 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) Subjects aged 20 years old or more and less than 65 years old.
2) Subjects whose fasting blood glucose levels are less than 126 mg/dL, and 2-h postprandial blood glucose levels are less than 200 mg/dL.
3) Subjects who have received a full explanation of the study, can understand its contents, and have given their written informed consent to participate in the study.
Key exclusion criteria
1) Subjects who are undergoing continuous medical treatment.
2) Subjects who regularly restrict carbohydrates.
3) Subjects who regularly take Foods for Specified Health Uses, Foods with Function Claims, health foods, etc., which may affect the study, and who cannot stop taking them during the study period.
4) Subjects who smoke 20 cigarettes or more per day.
5) Subjects with BMI of 30.0 kg/m2 or more.
6) Subjects who have difficulty in blood collection.
7) Subjects who excessively take alcohol.
8) Subjects who have a previous or current medical history of serious diseases in heart, liver, kidney, digestive organs, etc.
9) Subjects who are pregnant, planning to become pregnant, or lactating.
10) Subjects who have serious allergies to medicines and foods (especially eggs, wheat, and dairy products).
11) Subjects who are currently participating in another clinical trial of a drug or food, or participated in that trial within 4 weeks, or planning to participate in that trial after giving informed consent to participate in this trial.
12) Subjects who have donated over 200 mL of blood within 1 month and over 400 mL within 3 months before beginning this study.
13) Subjects who are judged as ineligible to participate in this study by the principal investigator or sub-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | EBIHARA |
Organization
Chiyoda Paramedical Care Clinic
Division name
Doctor
Zip code
103-0021
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9005
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | NUMA |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2022 | Year | 06 | Month | 17 | 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
| 2022 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 09 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054718
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| Registered date | File name |
| Research case data | |
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