UMIN-CTR Clinical Trial

Public title

Effect of a Food to Suppress the Increase in Postprandial Blood Glucose Level

Acronym

Effect of a Food to Suppress the Increase in Postprandial Blood Glucose Level

Scientific Title

Effect of a Food to Suppress the Increase in Postprandial Blood Glucose Level

Scientific Title:Acronym

Effect of a Food to Suppress the Increase in Postprandial Blood Glucose Level

Region

Japan

Condition

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine effect of a food to suppress the increase in postprandial blood glucose level.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Indexes for effectiveness (blood glucose, changes and Increase or decrease of insulin [screening, 30, 60, 90, and 120 minutes after rice intake], blood glucose AUC/iAUC, insulin AUC/iAUC [observation period I and II]).

Key secondary outcomes

*Indexes for safety
[1]Blood pressure, pulsation (screening, observation period I [before rice intake], observation period II [before rice intake])
[2]Weight, body fat percentage, BMI (screening, observation period I [before rice intake], observation period II [before rice intake])
[3]Doctor's questions (screening, observation period I [before rice intake, 120 minutes after rice intake], observation period II [before rice intake, 120 minutes after rice intake])
[4]Subject's diary (from one day before rice intake in observation period I to one day before rice intake in observation period II)

*Other indexes
[1]Hematologic test (screening)
[2]Blood biochemical test (screening)
[3]Urine analysis (screening)

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

[1]Oral ingestion of a test food (1 time).
[2]Rice intake.
[3]Observation.
[4]Washout (over 6 days)
[5]Oral ingestion of a placebo food (4g in one time, 1 time).
[6]Not intaking rice.
[7]Observation

Interventions/Control_2

[1]Not intaking rice.
[2]Rice intake.
[3]Observation.
[4]Washout (over 6 days)
[5]Oral ingestion of a test food (1 time).
[6]Rice intake.
[7]Observation

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Japanese males and females aged 20-59 years.
[2]Individuals who are healthy and are not suffered from a chronic malady including skin disease.
[3]Individuals who are anxious about high fasting blood glucose level.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who are or are under treatment or have a history of abnormal glucose tolerance, mental disabilities, sleep disorder, hypertension, diabetes, fat metabolism or the other serious dysfunctions.
[3]Individuals whose fasting blood glucose is over 126mg/dL and HbA1c (NGSP) is over 6.5mg/dL.
[4]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it).
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease.
[6]Individuals who have digestive organ disease (disease of an appendix is removed).
[7]Individuals whose menstrual period is during the test period and with serious anemia or poor physical condition during the period (only for females).
[8]Individuals whose BMI is over 30kg/m².
[9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[10]Individuals with serious anemia.
[11]Individuals who are sensitive to test products or causes severe allergy in a food and medical supplies.
[12]Individuals who cannot intake every loading food or test food.
[13]Individuals who are or are possibly pregnant, or are lactating.
[14]Individuals who are based on average alcohol per 1 day and exceeds 60g/day.
[15]Individuals whose life style will change during the test period (ex. travel for a long time).
[16Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[17]Individuals who participated in other clinical studies in the past 3 months.
[18]Individuals judged inappropriate for the study by the principal.

Target sample size

26

Name of lead principal investigator

1st name
Middle name
Last name	Mamoru Oki

Organization

Seishukai Medical Corporation Seishukai Hospital

Division name

Head

Zip code

Address

3-18-5 Matsugaya Taito-ku Tokyo 111-0036, JAPAN

TEL

03-3847-8866

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Riken Vitamin Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

01

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

01

Month

09

Day

Date of IRB

Anticipated trial start date

2018

Year

01

Month

25

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

01

Month

29

Day

Last modified on

2018

Year

03

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035195