UMIN-CTR Clinical Trial

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
Email	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
Email	m-takahashi@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031477