UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036242
Receipt number R000041281
Scientific Title A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level : Randomised double-blind placebo-controlled trial
Date of disclosure of the study information 2019/03/18
Last modified on 2020/03/05 18:26:30

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Basic information

Public title

A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level : Randomised double-blind placebo-controlled trial

Acronym

A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level

Scientific Title

A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level : Randomised double-blind placebo-controlled trial

Scientific Title:Acronym

A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of test food intake on the suppression of the elevation of postprandial blood glucose after ingesting glucose.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood glucose
*Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.

Key secondary outcomes

Insulin
*Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.


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

Prevention

Type of intervention

Food

Interventions/Control_1

Food containing test food + glucose 75 g, single ingestion [Wash out for 1 week] Food not containing test food + glucose 75 g, single ingestion

Interventions/Control_2

Food not containing test food + glucose 75 g, single ingestion [Wash out for 1 week] Food containing test food + glucose 75 g, single ingestion

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) Males and females, aged 20 - 65 years old.
2) Subjects whose fasting blood glucose level is from 110 mg/dL to 125 mg/dL or two-hour blood glucose level after 75 g glucose loading is from 140 mg/dL to 199 mg/dL, and who are judged normal-high or borderline type as the state of glycemia by the principal investigator.
3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

1) Subjects whose fasting blood glucose level is greater than or equal to 126 mg/dL and two-hour blood glucose level after 75 g glucose loading is greater than or equal to 200 mg/dL.
2) A medical history of malignant tumor, heart failure or myocardial infarction.
3) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4) Subjects who currently taking medications (including herbal medicines)
5) Subjects who are allergic to medications and/or the test food related products.
6) Subjects with irregular life rhythms such as shift workers, irregular eating habits.
7) Subjects who are pregnant, breast-feeding, or planning to get pregnant.
8) Subjects who have been enrolled in other clinical trials within the last 4 weeks before the agreement to participate in this trial.
9) Subjects who are considered as ineligible to participate in the study by the physician.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yasutaka
Middle name
Last name Makishima

Organization

Allegro Inc.

Division name

Clinical trial promotion department

Zip code

151-0051

Address

4F, BML Bldg. 5-21-3, Sendagaya, Shibuya-ku, Tokyo

TEL

03-5363-6821

Email

y-maki@bml.co.jp


Public contact

Name of contact person

1st name Fumiko
Middle name
Last name Kase

Organization

Allegro Inc.

Division name

Clinical trial promotion department

Zip code

151-0051

Address

4F, BML Bldg. 5-21-3, Sendagaya, Shibuya-ku, Tokyo

TEL

03-5363-6821

Homepage URL


Email

f-kase@bml.co.jp


Sponsor or person

Institute

Allegro Inc.

Institute

Department

Personal name



Funding Source

Organization

Pharma Foods International Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

MC Food Specialties Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tomisaka Clinic

Address

1-33-9, Hongo, Bunkyo-ku, Tokyo

Tel

03-3814-2662

Email

info@tomisaka.or.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

2019 Year 03 Month 18 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

2019 Year 02 Month 21 Day

Date of IRB

2019 Year 03 Month 13 Day

Anticipated trial start date

2019 Year 03 Month 18 Day

Last follow-up date

2019 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 03 Month 18 Day

Last modified on

2020 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041281


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name