UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030847 |
|---|---|
| Receipt number | 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 15:05:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Keisuke_Yasumoto@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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035218
