UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045225
Receipt number R000051662
Scientific Title Exploratory clinical study on the suppressive effect of the peptide on postprandial blood glucose level
Date of disclosure of the study information 2021/08/27
Last modified on 2022/04/27 11:42:50

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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 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 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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051662


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name