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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024356
Receipt No. R000027732
Scientific Title A study on the effect of functional food containing beverage on blood glucose level in human.
Date of disclosure of the study information 2016/10/16
Last modified on 2016/10/11

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Basic information
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
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Efficacy : Area under the curve of delta blood glucose level.
Safety : Incidence of adverse effects
Key secondary outcomes

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人社団慈昂会 福住内科クリニック (北海道)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 16 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 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
Other related information

Management information
Registered date
2016 Year 10 Month 11 Day
Last modified on
2016 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027732

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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