UMIN-CTR Clinical Trial

Basic information
Public title	Development and validation of a new appetite assessment method
Acronym	Development of a new appetite assessment method
Scientific Title	Development and validation of a Japanese version of an appetite assessment method
Scientific Title:Acronym	Development and validation of an appetite assessment method
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop and validate an appetite questionnaire.
Basic objectives2	Others
Basic objectives -Others	Repeatability
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Appetite
Key secondary outcomes	Eating behavior

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Participants conduct the appetite survey before and after consuming a standardised meal.
Interventions/Control_2
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	20 years-old <=
Age-upper limit	39 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy men and women age between 20 and 39 years old (body mass index between 18.5 and 30)
Key exclusion criteria	1.Not age between 20 and 39 years old 2.Not body mass index between 18.5 and 30 3.A participant who takes some medicine 4.A participant who has chronic disease 5.A participant who has smoking 6.A participant who gain or loss of weight more than 3 kg in the past 3 months, or plan to loss of weight during this research 7.A participant who will participant another research during this research 8.A participant who has food allergies
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Miyashita
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima,Tokorozawa, Saitama
TEL	04-2947-6774
Email	m.miyashita@waseda.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Miyashita
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	359-1192
Address	2-579-15 Mikajima,Tokorozawa, Saitama
TEL	04-2947-6774
Homepage URL
Email	m.miyashita@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Fondation Franco-Japonaise Sasakawa
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Waseda University
Address	1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel	03-5272-1639
Email	rinri@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	2021 Year 04 Month 14 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	Completed
Date of protocol fixation	2021 Year 02 Month 01 Day
Date of IRB	2021 Year 04 Month 13 Day
Anticipated trial start date	2021 Year 04 Month 15 Day
Last follow-up date	2022 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 14 Day
Last modified on	2022 Year 06 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050158