UMIN-CTR Clinical Trial

Basic information
Public title	Acute effects of dietary fiber and polyphenols intake on appetite and feeding behavior
Acronym	Acute effects of dietary fiber and polyphenols intake on appetite and feeding behavior
Scientific Title	Acute effects of dietary fiber and polyphenols intake on appetite and feeding behavior
Scientific Title:Acronym	Acute effects of dietary fiber and polyphenols intake on appetite and feeding behavior
Region	Japan

Condition
Condition	obesity
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the acute effects of dietary fiber and polyphenols intake on appetite and feeding behavior.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to examine the acute effects of dietary fiber and polyphenols intake on appetite and feeding behavior.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	appetite and feeding behavior
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	dietary fiber intake polyphenols intake placebo intake
Interventions/Control_2	In all conditions, subjects ingest the foods once.
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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy man and woman
Key exclusion criteria	none
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Kana Middle name Last name Konishi
Organization	Toyo University
Division name	Department of Food and Life Sciences
Zip code	3740193
Address	1-1-1, Izumino, Itakura-machi, Ora-gun, Gunma
TEL	0276829208
Email	konishi@toyo.jp

Public contact
Name of contact person	1st name Kana Middle name Last name Konishi
Organization	Toyo University
Division name	Department of Food and Life Sciences
Zip code	3740193
Address	1-1-1, Izumino, Itakura-machi, Ora-gun, Gunma
TEL	0276829208
Homepage URL
Email	konishi@toyo.jp

Sponsor
Institute	Toyo University
Institute
Department

Funding Source
Organization	JSPS
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	Toyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address	2100, Kujirai, Kawagoe city, Saitama, Japan
Tel	0492391440
Email	mlkks@toyo.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	2020 Year 10 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2024 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	2020 Year 08 Month 18 Day
Last modified on	2020 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047328

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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