UMIN-CTR Clinical Trial

Public title

A study on the effect of functional food containing beverage on blood glucose level in human.

Acronym

A study on the effect of functional food containing beverage on blood glucose level in human.

Scientific Title

A study on the effect of functional food containing beverage on blood glucose level in human.

Scientific Title:Acronym

A study on the effect of functional food containing beverage on blood glucose level in human.

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm the effect of functional food containing beverage on blood glucose increase.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Efficacy : Area under the curve of delta blood glucose level.
Safety : Incidence of adverse effects

Key secondary outcomes

Study type

Interventional

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

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects take a can of two kinds of functional foods containing beverage once in a day. After 6-days washout, subjects take a can of placebo beverage once in a day. After 6-days washout, subjects take a can of one kind of functional food containing beverage once in a day. In each time, subjects take 300g of rice 30mins after beverage intake.

Interventions/Control_2

Subjects take a can of one kind of functional food containing beverage once in a day. After 6-days washout, subjects take a can of two kinds of functional foods containing beverage once in a day. After 6-days washout, subjects take a can of placebo beverage once in a day. In each time, subjects take 300g of rice 30mins after beverage intake.

Interventions/Control_3

Subjects take a can of placebo beverage once in a day. After 6-days washout, subjects take a can of one kind of functional food containing beverage once in a day. After 6-days washout, subjects take a can of two kinds of functional foods containing beverage once in a day. In each time, subjects take 300g of rice 30mins after beverage intake.

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Healthy males aged 20 or more and less than 65 years-old.
2)Subjects with fasting blood glucose level 100 mg/dL or more and less than 126 mg/dL
3)Subjects who can visit hospital on designated day.
4)Subjects giving written informed consent.

Key exclusion criteria

1)Subjects with constant drug treatment.
2)Subjects who are contracting diabetes.
3)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
4)Subjects with a previous history of disease on heart, liver, kidney or digestive organs.
5)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
6)Subjects who drink alcohol a lot and smoke a lot.
7)Subjects who have an irregular sleep cycle, work shift or work on midnight shift.
8)Subjects who have allergic reaction to drug medicine and food.
9)Subjects whose systolic blood pressure is less than 90mmHg.
10)Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study.
11)Male subjects whose blood was collected more than 400 mL within the last twelve weeks.
12)Female subjects whose blood was collected more than 400 mL within the last sixteen weeks.
13)Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
14)Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
15)Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks.
16)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Target sample size

21

Name of lead principal investigator

1st name
Middle name
Last name	Norihito Murayama

Organization

Suntory Global Innovation Center Ltd.

Division name

Innovation Development Department

Zip code

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan

TEL

050-3182-0588

Email

Norihito_Murayama@suntory.co.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Watanabe

Organization

Suntory Global Innovation Center Ltd.

Division name

Innovation Development Department

Zip code

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan

TEL

050-3182-0593

Homepage URL

Email

H_Watanabe@suntory.co.jp

Institute

Suntory Global Innovation Center Ltd.

Institute

Department

Personal name

Organization

Suntory Global Innovation Center Ltd.

Organization

Division

Category of Funding Organization

Self funding

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

医療法人社団慈昂会　福住内科クリニック　（北海道）

Date of disclosure of the study information

2016

Year

10

Month

16

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

Preinitiation

Date of protocol fixation

2016

Year

10

Month

14

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

17

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

11

Day

Last modified on

2016

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027732