UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027486 |
|---|---|
| Receipt number | R000031477 |
| Scientific Title | The consecutive effects of timing of polyphenol ingestions on glucose and fat metabolism |
| Date of disclosure of the study information | 2017/05/25 |
| Last modified on | 2021/07/06 11:40:35 |
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Basic information
Public title
The consecutive effects of timing of polyphenol ingestions on glucose and fat metabolism
Acronym
The consecutive effects of timing of polyphenol ingestions on glucose and fat metabolism
Scientific Title
The consecutive effects of timing of polyphenol ingestions on glucose and fat metabolism
Scientific Title:Acronym
The consecutive effects of timing of polyphenol ingestions on glucose and fat metabolism
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 consecutive effects of timing of polyphenol ingestions on glucose and fat metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentration of blood glucose, insulin, incretin, triglyceride, free fatty acid
Key secondary outcomes
The concentration of hormones related to appetite, oxidative stress
Base
Study type
Interventional
Study design
Basic design
Parallel
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
7-days ingestion of polyphenol beverage (Morning trial)
Interventions/Control_2
7-days ingestion of polyphenol beverage (Evening trial)
Interventions/Control_3
7-days ingestion of placebo beverage (Morning trial)
Interventions/Control_4
7-days 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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
20 years-old <=, 40 years-old >
Obtained written informed consent from the participant before participation
Key exclusion criteria
1) To take medicine related to psychotropic, sleeping, steroid
2) Obesity (BMI>35kg/m2) and sleep apnea syndrome
3) High blood pressure (SBP:above140mmHg, and DBP:above 90mmHg)
4) To take medicine related to diabetes and hyperlipidemia
5) The principal investigator or the principal doctor judge the subject as inappropriate
Target sample size
40
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
Waseda University
Division name
Organization for University Research Initiatives
Zip code
162-8480
Address
2-2 Wakamatsu-cho, Shinjuku, Tokyo, 162-8480, Japan
TEL
+81-3-5369-7318
Homepage URL
m-takahashi@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Procedures concerning Research with Human Subjects, Waseda University
Address
1-104, Totsukamachi, Shinjuku-ku, Tokyo Bldg, #9, 2F
Tel
03-5272-4652
rps-management@list.waseda.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
| 2017 | Year | 05 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2017 | Year | 05 | Month | 25 | 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=R000031477
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
