UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019051 |
|---|---|
| Receipt number | R000022015 |
| Scientific Title | Randomized, Placebo-controlled, Clinical Study to Investigate the Anti-Metabolic Syndrome Effect of the Functional Food in humans |
| Date of disclosure of the study information | 2015/09/17 |
| Last modified on | 2016/02/16 09:47:57 |
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Basic information
Public title
Randomized, Placebo-controlled, Clinical Study to Investigate the Anti-Metabolic Syndrome Effect of the Functional Food in humans
Acronym
Box Lunch Study at Kanagawa Prefecture
Scientific Title
Randomized, Placebo-controlled, Clinical Study to Investigate the Anti-Metabolic Syndrome Effect of the Functional Food in humans
Scientific Title:Acronym
Box Lunch Study at Kanagawa Prefecture
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of functional food on metabolic syndrome in obese subjects with visceral fat accumulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
After the administration after 6 weeks, the start of administration after 12 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects take the test food(rice) during 12 weeks (non-holiday).
Interventions/Control_2
The subjects take the test food(Japanese tea) during 12 weeks (non-holiday).
Interventions/Control_3
The subjects take the test food(Side dish) during 12 weeks (non-holiday).
Interventions/Control_4
The subjects take the test food(rice,Japanese tea,Side dish) during 12 weeks (non-holiday).
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) Aged 20-65 years at informed consent
2) Visceral fat area >=100cm2 for male, >=80cm2 for female
3) Body-mass index (BMI) 25-30 kg/m2 for male, 23-30 kg/m2 for female
4)Fasting blood glucose =<125mg/dL
5) Obtained written informed consent from the subjects for the study participation
Key exclusion criteria
1) Pregnancy, nursing or planning to become pregnant during the study (female only)
2) Any other significant medical conditions
3) Uncontrolled metabolic syndrome, or diabetes with insulin treatment
4) Severe allergies to wheat, soy, egg, milk, crustacean shellfish
5) Severe sensitivity to caffeine
6) Implantable electronic medical devices
7) Wearable electronic medical devices
8) Mechanical life support equipment
9) Metals as implantable materials
10) Dialysis patients
11) Participation in other clinical trials at enrollment
12) Any other considered by a study physician to be inappropriate for inclusion
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichi Tanaka |
Organization
Medical Corporation Minato Mirai
Division name
President
Zip code
Address
2-2-1,minatoMirai,nisiku,Yokohama,Kanagawa,220-8139 Japan
TEL
045-640-1158
bento@crsu.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekazu Saito |
Organization
Not-for profit Organization Japan Clinical Research Support Unit
Division name
Clinical Research Department
Zip code
Address
Yushima D&A Building 3F,1-10-5,yushima,bunkyou-ku,Tokyo,113-0034 Japan
TEL
03-5842-7480
Homepage URL
bento@crsu.org
Sponsor or person
Institute
Not-for profit Organization Japan Clinical Research Support Unit
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kanagawa Prefecture
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
| 2015 | Year | 09 | Month | 17 | 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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 09 | 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
| 2015 | Year | 09 | Month | 17 | Day |
Last modified on
| 2016 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022015
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
