UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041459
Receipt number R000047328
Scientific Title Acute effects of dietary fiber and polyphenols intake on appetite and feeding behavior
Date of disclosure of the study information 2020/10/01
Last modified on 2021/05/26 17:08:37

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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 or person

Institute

Toyo University

Institute

Department

Personal name



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

20

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

2020 Year 07 Month 17 Day

Date of IRB

2020 Year 11 Month 09 Day

Anticipated trial start date

2020 Year 11 Month 10 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

2021 Year 05 Month 26 Day



Link to view the page

Value
https://center6.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