UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020885 |
|---|---|
| Receipt number | R000023534 |
| Scientific Title | Effects of timing of polyphenol beverage ingestion on health-related parameters |
| Date of disclosure of the study information | 2016/02/05 |
| Last modified on | 2021/07/06 10:49:48 |
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Basic information
Public title
Effects of timing of polyphenol beverage ingestion on health-related parameters
Acronym
Effects of timing of polyphenol beverage ingestion on health-related parameters
Scientific Title
Effects of timing of polyphenol beverage ingestion on health-related parameters
Scientific Title:Acronym
Effects of timing of polyphenol beverage ingestion on health-related parameters
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to examine the effects of timing of polyphenol beverage ingestion on health-related parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentrations of blood glucose
Key secondary outcomes
The concentrations of insulin, GLP-1, GIP-1, glucagon,ghrelin
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Acute ingestion of polyphenol beverage (Morning trial)
Interventions/Control_2
Acute ingestion of polyphenol beverage (Evening trial)
Interventions/Control_3
Acute ingestion of placebo beverage (Morning trial)
Interventions/Control_4
Acute ingestion of placebo beverage (Evening trial)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
20 yeras-old <=, 80 yeras-old >
Obtained written informed consent from the participant before participation.
Key exclusion criteria
Patients used glucose/insulin-lowering and NO related medication
No change of body weight within six month 5%>
No Heavy drinker(Men:40g>=, Women:20g>=)
Diagnosed as diabete and dyslipidemia by a doctor
Not taking the anti-oxidant, anti-obesity, anti-diabete supplementation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shigenobu |
| Middle name | |
| Last name | Shibata |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
162-8480
Address
2-2 Wakamatsu-cho, Shinjuku, Tokyo, 162-8480, Japan
TEL
+81-3-5369-7318
shibatas@waseda.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
1528550
Address
2-12-1, Ookayama Meguro-ku, Tokyo
TEL
+81-3-5734-2904
Homepage URL
takahashi.m.bp@m.titech.ac.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (S)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Grant-in-Aid for Young Scientists (B)
IRB Contact (For public release)
Organization
Waseda University
Address
Faculty of Science and Engineering
Tel
+81-3-5369-7318
takahashi.m.bp@m.titech.ac.jp
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
| 2016 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31522082/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31522082/
Number of participants that the trial has enrolled
17
Results
The concentrations of glucose at 120 min and 180 min after meal intake were significantly higher in the morning green tea trials than in the morning placebo trials. Additionally, the concentration of glucose was significantly lower in evening green tea trials than in the evening placebo trials at 60 min.
Results date posted
| 2021 | Year | 07 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Described in Method section
Participant flow
Described in Method section
Adverse events
None
Outcome measures
Described in Method section
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 04 | Day |
Last modified on
| 2021 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023534
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
