UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036710 |
|---|---|
| Receipt number | R000041803 |
| Scientific Title | Exploratory study of the effect of food ingredients on abdominal condition (SWE-2019-02-HBLACT) |
| Date of disclosure of the study information | 2019/05/12 |
| Last modified on | 2021/11/18 11:18:48 |
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Basic information
Public title
Exploratory study of the effect of food ingredients on abdominal condition (SWE-2019-02-HBLACT)
Acronym
Exploratory study of the effect of food ingredients on abdominal condition
Scientific Title
Exploratory study of the effect of food ingredients on abdominal condition (SWE-2019-02-HBLACT)
Scientific Title:Acronym
Exploratory study of the effect of food ingredients on abdominal condition
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratory evaluate the effect of food ingredients on abdominal condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of subjects with improved abdominal conditions at the end of the trial compared to before intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will take the functional food (high dose) once a day for 4 weeks.
Interventions/Control_2
Subjects will take the functional food (low dose) once a day for 4 weeks.
Interventions/Control_3
Subjects will take the placebo food once a day for 4 weeks.
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)Male and Female whose age are 20 <= years old <65.
(2) Subjects who are troubled by their abdominal condition.
(3) Subjects who can visit hospital on designated day.
(4) Subjects who are able to submit the written informed consents.
Key exclusion criteria
(1) Subjects who are with treatment.
(2) Subjects who constantly use drug medicine.
(3) Subjects who are with history of gastrointestinal surgery.
(4) Subjects who are attending other studies or attended other studies within the past 4 weeks.
(5) Female in pregnancy, lactation and scheduled pregnancy period.
(6) Subjects who are;
a) With present heart disorder, liver disorder, kidney disorder or gastrointestinal tract disorder,
b) With history of cardiac disorder or gastrointestinal tract disorder,
c) With diabetes mellitus, or
d) With allergy to the study foods.
(7) Subjects who are not negative by virus immune serology test result at the time of screening.
(8) Subjects who are deemed to be unsuitable by the investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Izumo |
Organization
SUNTORY WELLNESS LIMITED
Division name
Institute for Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0630
Takayuki_Izumo@suntory.co.jp
Public contact
Name of contact person
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Wakabayashi |
Organization
SUNTORY WELLNESS LIMITED
Division name
Institute for Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0599
Homepage URL
Kenichi_Wakabayashi@suntory.co.jp
Sponsor or person
Institute
SUNTORY WELLNESS LIMITED
Institute
Department
Personal name
Funding Source
Organization
SUNTORY WELLNESS LIMITED
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
Miyawaki Orthopedic Clinic Institutional Review Board
Address
3-1-6 Ariakecho, Eniwa City, Hokkaido
Tel
0123-33-4026
d-kameda@mediffom.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 12 | 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
| 2019 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 10 | Day |
Last modified on
| 2021 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041803
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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