UMIN-CTR Clinical Trial

Basic information
Public title	Postprandial effects of substance X on satiety in healthy human subjects.
Acronym	Postprandial effects of substance X on satiety.
Scientific Title	Postprandial effects of substance X on satiety in healthy human subjects.
Scientific Title:Acronym	Postprandial effects of substance X on satiety.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the satiety effects of substance X.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Subjective hunger and satiety (Visual Analogue Scale) [0-3 hours after intake of breakfast (farst-meal)] 2.Volume of meal (second-meal) intake [3 hours after intake of breakfast]
Key secondary outcomes

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	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake 2 butter rolls and water containing substance X as breakfast (first-meal). After 3 hours, intake fried rice as lunch (second-meal). -> 1-week washout -> Intake 2 butter rolls and water containing control substance as breakfast. After 3 hours, intake fried rice as lunch.
Interventions/Control_2	Intake 2 butter rolls and water containing control substance as breakfast. After 3 hours, intake fried rice as lunch. -> 1-week washout -> Intake 2 butter rolls and water containing substance X as breakfast (first-meal). After 3 hours, intake fried rice as lunch.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Healthy volunteers. 2)Employees at the Hayashibara CO., LTD. 3)Subjects who take meals regularly. 4)Subjects who signed the informed consent for participation in the study.
Key exclusion criteria	1)Subjects with medical history of severe disorders. 2)Subjects with surgical history of digestive system (except appendectomy). 3)Subjects with continuous medical treatment for chronic disease. 4)Pregnant or have possibility to become pregnant during the study or lactating women. 5)Subjects regularly using medicine, supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) that may affect the results of the study. 6)Subjects other than shift work. 7)Subjects who judged as unsuitable for this study by the principal investigator for any reasons.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Ishida
Organization	Hayashibara CO., LTD.
Division name	R & D Division, Development Unit
Zip code	7028006
Address	675-1, Fujisaki, Naka-ku, Okayama
TEL	086-276-3141
Email	yuki.ishida@hb.nagase.co.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Ishida
Organization	Hayashibara CO., LTD.
Division name	R & D Division, Development Unit
Zip code	7028006
Address	675-1, Fujisaki, Naka-ku, Okayama
TEL	086-276-3141
Homepage URL
Email	yuki.ishida@hb.nagase.co.jp

Sponsor
Institute	Hayashibara CO., LTD.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Ethics Committee of Hayashibara Co., Ltd.
Address	675-1, Fujisaki, Naka-ku, Okayama
Tel	086-276-3141
Email	HB96301@hb.nagase.co.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	株式会社林原 / Hayashibara CO., LTD. (Okayama)

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 07 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	2016 Year 12 Month 19 Day
Date of IRB	2016 Year 12 Month 19 Day
Anticipated trial start date	2017 Year 03 Month 08 Day
Last follow-up date	2017 Year 04 Month 30 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 03 Month 02 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030305