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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026371
Receipt No. R000030305
Scientific Title Postprandial effects of substance X on satiety in healthy human subjects.
Date of disclosure of the study information 2017/03/07
Last modified on 2017/09/01

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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
Middle name
Last name Yuki Ishida
Organization Hayashibara CO., LTD.
Division name R & D Center, Food Materials Division
Zip code
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
Middle name
Last name Yuki Ishida
Organization Hayashibara CO., LTD.
Division name R & D Center, Food Materials Division
Zip code
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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 03 Month 08 Day
Last follow-up date
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
2017 Year 09 Month 01 Day


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

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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