UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050049 |
|---|---|
| Receipt number | R000056984 |
| Scientific Title | Effect of lifestyle modification and the test food containing Salacia extract |
| Date of disclosure of the study information | 2023/01/26 |
| Last modified on | 2023/12/22 20:53:54 |
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Basic information
Public title
Effect of lifestyle modification and the test food containing Salacia extract
Acronym
Effect of lifestyle modification and the test food containing Salacia extract
Scientific Title
Effect of lifestyle modification and the test food containing Salacia extract
Scientific Title:Acronym
Effect of lifestyle modification and the test food containing Salacia extract
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of lifestyle modification and the test food containing Salacia extract on Okinawa residents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Annual health check-up data (HbA1c, Blood glucose level)
Key secondary outcomes
Annual health check-up data (Others), Lifestyle habits questionnaire
<Interim assessment> Self check by finger-prick blood test (Total protein, Albumin, AST, ALT, GTP, Total cholesterol, HDL-cholesterol, Triglyceride, Blood urea nitrogen, Creatinine, Uric acid, Blood glucose level, HbA1c)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Lifestyle modification and intake of the test food containing Salacia extract for 6 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Employees of Orion Breweries, Ltd.
2. Subjects whose fasting blood glucose levels and HbA1c in 2022 were jugged as criteria A, B, C1), or C2) according to the criteria category by Japan Society of Ningen Dock
3. Subjects who have understood the purpose and contents of the study and agree to participate by signing the written informed consent
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Nakabayashi |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Food Department, Healthcare Products Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL
072-640-0131
k.nakabayashi@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Nakabayashi |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Food Department, Healthcare Products Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL
072-640-0131
Homepage URL
k.nakabayashi@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Orion Breweries, Ltd.
Name of secondary funder(s)
Orion Breweries, Ltd.
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
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 | 01 | Month | 26 | 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
28
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
| 2022 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056984
| 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 |
