UMIN-CTR Clinical Trial

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
Email	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
Email	takahashi.m.bp@m.titech.ac.jp

Sponsor
Institute	Waseda University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023534