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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048002
Receipt No. 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 2022/06/09

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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
Email 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
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

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
Email 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 Preinitiation
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 06 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054718

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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