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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036710
Receipt No. 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 2019/08/26

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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
Email 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
Email Kenichi_Wakabayashi@suntory.co.jp

Sponsor
Institute SUNTORY WELLNESS LIMITED
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041803

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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