UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025761 |
|---|---|
| Receipt number | 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 13:48:40 |
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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
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
H_Watanabe@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029583
