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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034518
Receipt No. R000039357
Scientific Title A study
Date of disclosure of the study information 2018/10/16
Last modified on 2018/10/16

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Basic information
Public title A study
Acronym A study
Scientific Title A study
Scientific Title:Acronym A study
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate for reduction of body fat mass including visceral fat and for safety when supplementation with food containing ingredients of plant origin for 12 weeks for healthy adult men and women with BMI of 23.0 kg/m2
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Abdominal visceral fat area
Key secondary outcomes Abdominal subcutaneous fat area, abdominal total fat area, waist circumference

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Take two capsules of the test food orally at dinner for 12 weeks
Interventions/Control_2 Take two capsules of the placebo food orally at dinner 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
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Japanese males and females aged of 20-64 years.
2) Subjects whose BMI values are 23.0 or more and less than 30.0.
3) Subjects who can visit the hospital/clinic on the scheduled visit date
4)Subjects who agreed in writing prior to the start of the trial with sufficient understanding of the purpose and contents of this study
Key exclusion criteria 1) Subjects who are under treatment or have a history of serious liver damage/disease, kidney disease, heart disease, lung disease, gastrointestinal disease (including gastrectomy), other severe disorders, or diabetes
2) Subjects who are under treatment (Excluding transient treatment such as common cold)
3) Subjects who cannot maintain their own life-style
4) Subjects who plan to travel overseas or have a long business trip during this study period
5) Subjects who are shift workers or graveyard shift workers
6) Subjects who use oral medication or supplements which may affect this study
7) Subjects drink alcohol over 1,000mL in terms of beer (= 40 mL of pure alcohol) per day
8) Subjects smoke over average 20 cigarettes per day
9) Subjects who are pregnant, lactation, or planning to become pregnant
10) Subjects who are sensitive to test product or other foods, and medical products.
11) Subjects who cannot take the test food as instructed
12) Subjects who donated blood component or more than 200 mL of whole blood from the last one month just before the start of the study
13) Subjects who have experienced sickness due to blood collection
14) Subjects in constipation (frequency of defecation twice or less a week, feces is hard, difficulty of defecation, feeling of remaining feces)
15) Subjects who participated in other clinical studies in the past 3 months
16) Subjects who have some metal inside the body
17) Subjects judged as unsuitable for this study by the principal investigator
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name tomita shinpei
Organization NDRC
Division name clinical
Zip code
Address 452-1
TEL 0123-34-0412
Email s-tomita@ndrcenter.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toyotada Ashino
Organization New drug research center, Inc.
Division name Clinical Research Dept.
Zip code
Address 452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL 0123-34-0412
Homepage URL
Email t-ashino@ndrcenter.co.jp

Sponsor
Institute New drug research center, Inc.
Institute
Department

Funding Source
Organization NDRC
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 福原医院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 16 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 04 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 10 Month 16 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039357

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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