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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048106
Receipt No. R000054562
Scientific Title Effect of health instructions and the test food containing Salacia extract
Date of disclosure of the study information 2022/06/20
Last modified on 2022/06/20

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Basic information
Public title Effect of health instructions and the test food containing Salacia extract
Acronym Effect of health instructions and the test food containing Salacia extract
Scientific Title Effect of health instructions and the test food containing Salacia extract
Scientific Title:Acronym Effect of health instructions and the test food containing Salacia extract
Region
Japan

Condition
Condition Subjects of Specific Health Guidance
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of health instructions and the test food containing Salacia extract
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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 Intake of the test food containing Salacia extract for 9 months
Interventions/Control_2 Health instructions and intake of the test food containing Salacia extract for 9 months
Interventions/Control_3 Observation only
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
40 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria 1)Subjects of Specific Health Guidance in Fujiidera-city
2)Subjects whose fasting blood glucose levels are not less than 100 mg/dL or HbA1c are not less than 5.6%
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 150

Research contact person
Name of lead principal investigator
1st name Haruka
Middle name
Last name Hamasaki
Organization KOBAYASHI Pharmaceutical Co., Ltd.
Division name Research & Development Dept., Healthcare Division
Zip code 567-0057
Address 1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL 072-640-0131
Email h.hamasaki@kobayashi.co.jp

Public contact
Name of contact person
1st name Haruka
Middle name
Last name Hamasaki
Organization KOBAYASHI Pharmaceutical Co., Ltd.
Division name Research & Development Dept., Healthcare Division
Zip code 567-0057
Address 1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL 072-640-0131
Homepage URL
Email h.hamasaki@kobayashi.co.jp

Sponsor
Institute KOBAYASHI Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
Email 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
2022 Year 06 Month 20 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 25 Day
Date of IRB
2022 Year 05 Month 26 Day
Anticipated trial start date
2022 Year 06 Month 20 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 20 Day
Last modified on
2022 Year 06 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054562

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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