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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030847
Receipt No. R000035218
Scientific Title A study to evaluate the effect of decreasing postprandial glucose levels of functional food
Date of disclosure of the study information 2018/01/24
Last modified on 2018/04/04

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Basic information
Public title A study to evaluate the effect of decreasing postprandial glucose levels of functional food
Acronym A study to evaluate the effect of decreasing postprandial glucose levels of functional food
Scientific Title A study to evaluate the effect of decreasing postprandial glucose levels of functional food
Scientific Title:Acronym A study to evaluate the effect of decreasing postprandial glucose levels 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 food on blood glucose increase.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy : Area under the curve of delta blood glucose level.
Safety : Incidence of adverse events
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 YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Subjects will take the test food once a day. After more than 1 day of washout period, subjects will take the placebo food once a day.
Interventions/Control_2 Subjects will take the placebo food once a day. After more than 1 day of washout period, subjects will take the test food once a day.
Interventions/Control_3
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Males and females over 20 years old
2. Understanding the study and submitting the written informed consent before the study
Key exclusion criteria 1. Systolic pressure <90 mmHg
2. Subjects who are pregnant or lactating.
3. Subjects who donated over 200ml blood components or whole blood within 4 weeks
4. Male Subjects who donated over 400ml whole blood within 12 weeks
5. Female who donated over 400ml whole blood within 16 weeks
6. 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.
7. 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.
8. Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks.
9.
a) Subjects with disease on heart, liver, kidney or other organs complication.
b) Subjects with a previous history of disease on circulatory organs
c) Subjects who are contracting diabetes.
d) Subjects with test food allergy
10. Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Nonaka
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 050-3182-0587
Email Yuji_Nonaka@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Yasumoto
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 050-3182-0496
Homepage URL
Email Keisuke_Yasumoto@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
2018 Year 01 Month 24 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
2018 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 19 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
2018 Year 01 Month 17 Day
Last modified on
2018 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035218

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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