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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023253
Receipt No. 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

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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
Email 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
Email Masayuki_Ida@suntory.co.jp

Sponsor
Institute Suntory Wellness Limited
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026798

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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