UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023253 |
|---|---|
| Receipt number | R000026798 |
| Scientific Title | Test of the visceral fat reduction effect of food ingredient |
| Date of disclosure of the study information | 2016/07/21 |
| Last modified on | 2017/07/20 09:16:59 |
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Basic information
Public title
Test of the visceral fat reduction effect of food ingredient
Acronym
Test of the visceral fat reduction effect of food ingredient
Scientific Title
Test of the visceral fat reduction effect of food ingredient
Scientific Title:Acronym
Test of the visceral fat reduction effect of food ingredient
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the visceral fat reduction efficacy and safety of food ingredient
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal visceral fat area at 8th week, 12th week of intake
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingredient-containing food, 12 weeks
Interventions/Control_2
Ingredient-free food, 12 weeks
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) 20 years of age or older.
2) 25 kg/m2 <= BMI < 30 kg/m2.
3) Submitting the written informed consent before this study.
Key exclusion criteria
1) With continuous treatment
2) With previous and present serious disease such as liver disorder, kidney disorder, cardiac affection, lung disorder, digestive disorder, organ disorder, diabetes mellitus, food allergy.
3) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food.
4) Female in pregnancy, lactation and scheduled pregnancy period.
5) Investigator's judgment for other reason.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Izumo |
Organization
Suntory Wellness Limited
Division name
Institute For Health Care Science
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0630
Takayuki_Izumo@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Ida |
Organization
Suntory Wellness Limited
Division name
Institute For Health Care Science
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0752
Homepage URL
Masayuki_Ida@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
None
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 21 | 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 | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 20 | Day |
Last modified on
| 2017 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026798
