UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036086
Receipt number R000041037
Scientific Title Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.
Date of disclosure of the study information 2020/03/22
Last modified on 2019/09/18 13:50:59

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Basic information

Public title

Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.

Acronym

Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.

Scientific Title

Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.

Scientific Title:Acronym

Confirmation test on the inhibitory effect on blood sugar increase by ingesting test food.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of suppression of increase in blood glucose level by ingestion of wheat albumin or wheat albumin and carrageen.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

<Efficacy>
Area under the curve of blood glucose level from time zero to the 120 minutes.
Blood glucose level at the time of blood sampling.

Key secondary outcomes

<Efficacy>
Cmax of blood glucose level
Tmax of blood glucose level
Area under the curve of blood insulin level from time zero to the 120 minutes
Cmax of blood insulin level
Tmax of blood insulin level


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

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Single intake of Capsules containing wheat albumin

Interventions/Control_2

Single intake of Capsules containing wheat albumin and carrageen

Interventions/Control_3

Single intake of Capsules containing cellulose

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 equal to or more than 20 years and less than 65 years old
2. In the 75g oral glucose tolerance test, subjects with a fasting blood glucose level of 110 mg / dL or more and less than 126 mg / dL or a 2 hour value of 140 mg / dL or more and less than 200 mg / dL.
3. Possible study volunteer to visit
4. Subjects who recognize the object and contents of the study and submit the written informed consent

Key exclusion criteria

1. Subjects who develop diabetes (Recommended by Japan Diabetes Society).
2. Subjects who have a history of large surgery (gastrectomy,gastrointestinal suture, intestinal resection) on the gastrointestinal except who resect the cecum.
3. Subjects who have marked impairment of heart, liver, kidney, thyroid, and other diseases.
4. Subjects who experienced unpleasant feeling by drawing blood in the past.
5. Subjects who have difficulty drawing blood from the peripheral vein.
6. Subjects who donated 400 ml of blood within 12weeks or component blood donation 200 ml of blood within 4weeks prior to the study.
7. Subjects who are allergic to the test food or who have serious drugs or food allergies.
8. Shift worker and night worker.
9. Subjects whose eating habits are extremely irregular.
10. Heavy drinkers(Average of the amount of pure alcohol per day 40 g or more).
11. Heavy Smokers(More than 21 on average per day)
12. Subjects who are positive for one or more items in the results of virus / immunologic serology examination at the time of prior to the study
13. Pregnant women or breast-feeding women.
14. Subjects who regularly use medicines, health foods, etc. that may affect the study
15. Sujects who was judged ineligibles by clinician in this trial.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Shinpei
Middle name
Last name Tomita

Organization

New drug research center, Inc.

Division name

General Manager Clinical Research Dept.

Zip code

061-1405

Address

452-1Toiso,Eniwa-shi,Hokkaido, Japan

TEL

0123-34-0412

Email

s-tomita@ndrcenter.co.jp


Public contact

Name of contact person

1st name Yoshitaka
Middle name
Last name Hatakeyama

Organization

New Drug Research Center, Inc.

Division name

Clinical Research Dept.

Zip code

061-1405

Address

452-1Toiso,Eniwa-shi,Hokkaido, Japan

TEL

0123-34-0412

Homepage URL


Email

y-hatakeyama@ndrcenter.co.jp


Sponsor or person

Institute

Nissin Pharma Inc.

Institute

Department

Personal name



Funding Source

Organization

Nissin Pharma Inc.

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

Miyawaki Orthopedic Clinic Industrial Review Board

Address

3-1-6 Ariaketyou,Eniwa-shi,Hokkaido, Japan

Tel

0123-33-4026

Email

d-kameda@mediffom.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

2020 Year 03 Month 22 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

12

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 05 Day

Date of IRB

2019 Year 02 Month 05 Day

Anticipated trial start date

2019 Year 03 Month 06 Day

Last follow-up date

2019 Year 03 Month 23 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 05 Day

Last modified on

2019 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041037


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name