UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021529 |
|---|---|
| Receipt number | R000024475 |
| Scientific Title | Verification of the antiobesity effect of a plant extractIngredient G-PX |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2016/11/17 14:29:13 |
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Basic information
Public title
Verification of the antiobesity effect of a plant extractIngredient G-PX
Acronym
Verification of the antiobesity effect of a plant extract
Scientific Title
Verification of the antiobesity effect of a plant extractIngredient G-PX
Scientific Title:Acronym
Verification of the antiobesity effect of a plant extract
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and investigate the antiobesity effect before and after the consumption of a test food, using placebo as the control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the visceral fat area between before consumption of the test food and at the end of consumption
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
once a day for 12weeks
Interventions/Control_2
Placebo capsule 10mg once a day for 12weeks
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)Men and women aged >= 20years
(2)Those with BMI in the range>=25to<30
(3)Those who can visit the specified institution on the scheduled day of visit
(4)Those who adequately understand the objective and details of this study, and give written informed consent
Key exclusion criteria
(1)Those who are receiving treatment at the time of participation in the study
(2)Pregnant (or possibly pregnant) or lactating women
(3)Those who have donated blood components or 200 mL of whole blood within 4 weeks prior to the consumption of the test food
(4)Those who have donated 400 mL of whole blood within 16 weeks prior to the consumption of the test food
(5)Those who have had >1,000 mL of blood collected within 48 weeks prior to the consumption of the test food
(6)Those who are participating in another trial or study
(7)Those who meet any of the following criteria:
i.Those with heart, liver, or kidney disease (including complications of other diseases)
ii.Those with a history of cardiovascular disease
iii.Those with diabetes mellitus
iv.Those who are being treated for or with a history of serious diseases including cancer and asthma
(8)Those with a history of major surgery in the gastrointestinal regions, including gastrectomy, gastrointestinal suture, and intestinal resection
(9)Those with severe food allergy
(10)Those who routinely take supplements that contain the same components as the test food
(11)Those judged inadequate to enroll in the study at the discretion of the principal investigator or subinvestigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kuriki |
Organization
Ezaki Glico Co., Ltd.,
Division name
Institute of Health Sciences
Zip code
Address
4-6-5 Utajima, Nishi-Yodogawa, Osaka-shi Osaka-fu
TEL
+81-6-6477-8425
kuriki-takashi@glico.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryou Kakutani |
Organization
Ezaki Glico Co., Ltd.
Division name
Institute of Helth Sciences
Zip code
Address
4-6-5, Utajima, Nishi-yodogawa, Osaka
TEL
06-6477-8362
Homepage URL
kakutani-ryou@glico.co.jp
Sponsor or person
Institute
Ezaki Glico Co.,Ltd.,Institute of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Glico Nutrition 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
Address
Tel
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
医療法人共創会AMC西梅田クリニック
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 18 | 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
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 10 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 10 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 18 | Day |
Last modified on
| 2016 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024475
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
