UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory clinical 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	Exploratory clinical 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 (0, 30 min), 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 peptide food
Interventions/Control_2	A single intake of 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 125 mg/dL or less, and 2-h postprandial blood glucose levels are 199 mg/dL or less. 3) Subjects who have received a full explanation of the study, 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 take Foods for Specified Health Uses, Foods with Function Claims, health foods, etc., which may affect the study, and who can not stop taking them during the study period. 3) Subjects who smoke 20 cigarettes or more per day. 4) Subjects with BMI of 30.0 kg/m2 or more. 5) Subjects who have difficulty in blood collection. 6) Subjects who are pregnant, planning to become pregnant, or lactating. 7) Subjects who have a past or current history of serious diseases of the heart, liver, kidney, digestive organs, etc. 8) Subjects who excessively take alcohol (60 g/day or more). 9) Subjects who have serious allergies to medicines and foods (especially eggs, wheat, and dairy products). 10) Subjects who are currently participating in another clinical trial of a drug or food, or participated in that trial within 4 weeks, or plan to participate in that trial after giving informed consent to participate in this trial. 11) Subjects who have donated over 200 mL of blood within 1 month and over 400 mL within 3 months before beginning this study. 12) Subjects who are judged as ineligible to participate in this study by the principal investigator or sub-investigator.
Target sample size	18

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	101-0047
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-5548
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	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
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 Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
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	2021 Year 08 Month 27 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	2021 Year 07 Month 19 Day
Date of IRB	2021 Year 07 Month 16 Day
Anticipated trial start date	2021 Year 08 Month 27 Day
Last follow-up date	2021 Year 10 Month 11 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 08 Month 23 Day
Last modified on	2022 Year 04 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051662