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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033908
Receipt No. R000038654
Scientific Title A study to evaluate the effect of test food on body fat-reducing.
Date of disclosure of the study information 2018/08/29
Last modified on 2019/02/26

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Basic information
Public title A study to evaluate the effect of test food on body fat-reducing.
Acronym A study to evaluate the effect of test food on body fat-reducing.
Scientific Title A study to evaluate the effect of test food on body fat-reducing.
Scientific Title:Acronym A study to evaluate the effect of test food on body fat-reducing.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of a test food on the reduction of body fat.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body fat area determined by CT
Key secondary outcomes Body weight, body mass index, waist circumference, body fat percentage

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 Daily intakes of a test food for 12 weeks
Interventions/Control_2 Daily intakes of a placebo food for 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
70 years-old >
Gender Male and Female
Key inclusion criteria 1.Subjects whose BMI values are over 25 but less than 30.
Key exclusion criteria 1.Individuals being patient or have a history of serious disease of liver, kidney, heart, internal organs and diabetes.
2.Individuals who cannot quit to intake of supplements and/or medicine which may affect the results of measurement.
3.Individuals who are allergic to the test foods
4.Individuals who are pregnant, lactation, and planning to be pregnant
5.Subjects who drink alcohol a lot (60 g and more of alcohol a day on average) and/or smoke a lot (20 and more cigarettes a day on average)
6.Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift
7.Individuals who are judged as ineligible to participate this trial by physician
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Ishikawa
Organization Medical Corporation Shoureikan Sinsapporo Seiryo Hospital
Division name Internal Medicine
Zip code
Address 4-2-1-30 , Atsubetsuhigashi, Atsubetsu-ku, Sapporo, Hokkaido
TEL 011-898-2151
Email Ishikawa_seiryo@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isao Takehara
Organization Clinical Support Corporation Co., Ltd
Division name PI-Food Service Division
Zip code
Address 4-1 South 1 West 8, Chuo-ku, Sapporo, Hokkaido
TEL 011-223-3130
Homepage URL
Email takehara@csc-smo.co.jp

Sponsor
Institute Medical Corporation Shoureikan Sinsapporo Seiryo Hospital
Institute
Department

Funding Source
Organization Asahi Group Holdings, 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
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
2018 Year 08 Month 29 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 No longer recruiting
Date of protocol fixation
2018 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 29 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
2018 Year 08 Month 27 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038654

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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