UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014066 |
|---|---|
| Receipt number | R000016376 |
| Scientific Title | Effect of Chlorogenic Acids on Visceral Perception in Normal and Functional Dyspepsia |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2016/11/13 23:39:49 |
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Basic information
Public title
Effect of Chlorogenic Acids on Visceral Perception in Normal and Functional Dyspepsia
Acronym
Chlorogenic Acids on Visceral Perception
Scientific Title
Effect of Chlorogenic Acids on Visceral Perception in Normal and Functional Dyspepsia
Scientific Title:Acronym
Chlorogenic Acids on Visceral Perception
Region
| Japan |
Condition
Condition
Functional Dyspepsia
Classification by specialty
| Medicine in general | Gastroenterology | Psychosomatic Internal Medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The first aim of this study is to clarify the increased visceral perception to caffein beverage in functional dyspepsia. The second aim of this study is to find that chlorogenic acids beverage has low stimulatory action on the upper GI tract in functional dyspepsia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
ordinate scale of the gastrointestinal symptoms
Key secondary outcomes
ordinate scale of the taste and odor
POMS
gastrointestinal hormones
EGG
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
coffee beverage
Interventions/Control_2
chlorogenic acids beverage
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
postprandial distress syndrome (PDS) of functional dyspepsia diagnosed with Rome III criteria
healthy subjects as controls
Key exclusion criteria
history and present illness of serious medical, surgical, and psychiatric diseases including allergic diathesis, medication, pregnancy and breast feeding
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Fukudo, MD, PhD |
Organization
Tohoku University Graduate School of Medicine
Division name
Departments of Behavioral Medicine and Psychosomatic Medicine
Zip code
Address
2-1 Seiryo, Aoba, Sendai 980-8575, Japan
TEL
022-717-8214
sfukudo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Fukudo, MD, PhD |
Organization
Tohoku University Graduate School of Medicine
Division name
Departments of Behavioral Medicine and Psychosomatic Medicine
Zip code
Address
2-1 Seiryo, Aoba, Sendai 980-8575, Japan
TEL
022-717-8214
Homepage URL
http://www.umin.ac.jp/ctr/UMIN-CTR
sfukudo@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kao Co. Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.umin.ac.jp/ctr/UMIN-CTR
Publication of results
Unpublished
Result
URL related to results and publications
http://www.umin.ac.jp/ctr/UMIN-CTR
Number of participants that the trial has enrolled
Results
Data are not provided yet.
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Data are not provided yet.
Management information
Registered date
| 2014 | Year | 05 | Month | 25 | Day |
Last modified on
| 2016 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016376
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
