UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052564 |
|---|---|
| Receipt number | R000059952 |
| Scientific Title | Effect verification of taking Sorghums in preventing lifestyle-related diseases |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2024/03/25 14:28:56 |
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Basic information
Public title
Effect verification of taking Sorghums in preventing lifestyle-related diseases
Acronym
Effect verification of taking Sorghums in preventing lifestyle-related diseases
Scientific Title
Effect verification of taking Sorghums in preventing lifestyle-related diseases
Scientific Title:Acronym
Effect verification of taking Sorghums in preventing lifestyle-related diseases
Region
| Japan |
Condition
Condition
Non-handicapped person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of whether sorghum intake is effective in preventing lifestyle-rerated diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
Glucose metabolism
Blood test values involved in lipid metabolism
Weight
Blood pressure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take cooked Sorghums for 12weeks (200g/day)
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Abdominal circumference
Male:85cm or more
Femal:90cm or more
Persons who have given their consent in writing.
Key exclusion criteria
Those who are receiving treatment for lifestyle-related diseases.
Those who are receiving treatment for some kind of diseases.
Those who currently have or have history of severe diseases.
Take supplements or nutrition fortified food habitually.
Those who currently have or have history of drug and/or food allergies.
Those who joined other clinical trials within 1month before receiving informed consent in this study,or those who are currently joining other clinical trials.
Consume alcohol excessively(alcohol equivalent 60g or more /day)
Have smoking habit.
Are judged by the investigator to be unsuitable for participating in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of agriculture graduate school, Kyushu university
Division name
Laboratory of Systematic Forest and forest Products Science
Zip code
819-0395
Address
744 motooka nishiku-fukuoka, Fukuoka Japan
TEL
0928024675
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Miyazaki |
Organization
Faculty of agriculture graduate school, Kyushu university
Division name
Laboratory of Systematic Forest and forest Products Science
Zip code
815-8540
Address
Room 403 GIC building, 4-9-1 shiobaru minamiku-fukuoka, Fukuoka Japan
TEL
0925539458
Homepage URL
miyazaki.hiomi.309@m.kyushu-u.co.jp
Sponsor or person
Institute
Faculty of agriculture graduate school, Kyushu university
Institute
Department
Personal name
Funding Source
Organization
KURUME RESEARCH PARK Company Limited
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
BEST AMENITY Company Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Building 6F 1-9-10 Hamamatsucho Minato-ku Tokyo Japan
Tel
03-5408-1590
shiba_palace@s-palace-clinic.com
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
| 2023 | Year | 10 | Month | 23 | 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
| 2023 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059952
