UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043092 |
|---|---|
| Receipt number | R000049187 |
| Scientific Title | Evaluation study for intake of a supplement on improvement in blood glucose and metabolic syndrome |
| Date of disclosure of the study information | 2021/01/24 |
| Last modified on | 2021/01/22 19:47:32 |
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Basic information
Public title
Evaluation study for intake of a supplement on improvement in blood glucose and metabolic syndrome
Acronym
Evaluation study for intake of a supplement on improvement in metabolic syndrome
Scientific Title
Evaluation study for intake of a supplement on improvement in blood glucose and metabolic syndrome
Scientific Title:Acronym
Evaluation study for intake of a supplement on improvement in metabolic syndrome
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate improvement in blood glucose and metabolic syndrome by taking the supplement
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose (0-4-8w)
Key secondary outcomes
blood triglyceride
serum LDL-choresterol
BAP
d-ROM
body composition (body weight, body mass index, body fat percentage)
total fat area, Visceral fat area,subcutaneous fat area
height
(0-4-8w)
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intake the supplement for 8 weeks
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 20 to 59 years old
2) Subjects who satisfy one or more of the following criteria
- 100 to 125mg/dL of blood glucose
- 23 to 30 kg/m2 of BMI
- 120 to 199 mg/dL of blood triglyceride
- 120 to 159 mg/dL of serum LDL-choresterol
3) Subjects who can take 30mL/observation of blood collection
4) Subjects who can fast from 12 hours before the observations
5) Subjects who can agree to go to the test institute to take CT scan
6) Subjects who can take CT scan 2 time during the test period
Key exclusion criteria
1) Subjects with histories of severe liver disorder, renal disorder or heart disease
2) Subjects who participate in other clinical trials
3) Subjects who are currently attending the hospital, taking medical treatments or having dose of medicines
4) Subjects who are pregnant, breast-feeding or have possibility (hope) of pregnancy
5) Subjects who can be allergic to ingredients of the test product
6)Subjects who are taking foods or supplements that can affect the test result
7) Subjects who are taking medicines that can affect the test result
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Azusa |
| Middle name | |
| Last name | Nishi |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
a_kouno@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
EZAKI GLICO CO.,LTD.
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
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
| 2021 | Year | 01 | Month | 24 | 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
40
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
| 2020 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 06 | 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
| 2021 | Year | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049187
