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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025761
Receipt No. R000029583
Scientific Title An exploratory study on the effect of functional food
Date of disclosure of the study information 2017/01/26
Last modified on 2018/07/18

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Basic information
Public title An exploratory study on the effect of functional food
Acronym An exploratory study on the effect of functional food
Scientific Title An exploratory study on the effect of functional food
Scientific Title:Acronym An exploratory study on the effect of functional food
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect of functional food containing beverage on blood glucose increase.
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.
Safety : Incidence of adverse effects
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Subjects take a bottle of placebo beverage once in a day. After 6-9 days washout, subjects take a bottle of one kind of functional food containing beverage once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (low dose) once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (high dose) once in a day. In each time, subjects take 75g of glucose 30mins after beverage intake.
Interventions/Control_2 Subjects take a bottle of one kind of functional food containing beverage once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (low dose) once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (high dose) once in a day. After 6-9 days washout, subjects take a bottle of placebo beverage once in a day. In each time, subjects take 75g of glucose 30mins after beverage intake.
Interventions/Control_3 Subjects take a bottle of two kinds of functional food containing beverage (low dose) once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (high dose) once in a day. After 6-9 days washout, subjects take a bottle of placebo beverage once in a day. After 6-9 days washout, subjects take a bottle of one kind of functional food containing beverage once in a day. In each time, subjects take 75g of glucose 30mins after beverage intake.
Interventions/Control_4 Subjects take a bottle of two kinds of functional food containing beverage (high dose) once in a day. After 6-9 days washout, subjects take a bottle of placebo beverage once in a day. After 6-9 days washout, subjects take a bottle of one kind of functional food containing beverage once in a day. After 6-9 days washout, subjects take a bottle of two kinds of functional food containing beverage (low dose) once in a day. In each time, subjects take 75g of glucose 30mins after beverage intake.
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
70 years-old >
Gender Male and Female
Key inclusion criteria Subjects whose past fasting blood glucose levels were between 100 mg/dL or more and less than 130 mg/dL are screened by 75 g OGTT and subjects who are diagnosed as borderline hyperglycemia or high normal blood glucose will be selected.
Key exclusion criteria (1)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(2)Subjects with disease on heart, liver, kidney or other organs complication.
(3)Subjects with a previous history of disease on circulatory organs
(4)Subjects who have allergic reaction to drug medicine and food.
(5)Subjects who drink alcohol a lot and smoke a lot.
(6)Subjects who have an extremely irregular dietary habit.
(7)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
(8)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihito Murayama
Organization Suntory Global Innovation Center Ltd.
Division name Research Institute
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 Research Institute
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 26 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
2017 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2017 Year 05 Month 15 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 20 Day
Last modified on
2018 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029583

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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