UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023499 |
|---|---|
| Receipt number | R000026735 |
| Scientific Title | Effect of a grain-derived processed product on visceral fat area |
| Date of disclosure of the study information | 2016/08/28 |
| Last modified on | 2019/07/30 13:15:05 |
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Basic information
Public title
Effect of a grain-derived processed product on visceral fat area
Acronym
Effect of a grain-derived processed product on visceral fat area
Scientific Title
Effect of a grain-derived processed product on visceral fat area
Scientific Title:Acronym
Effect of a grain-derived processed product on visceral fat area
Region
| Japan |
Condition
Condition
healthy humans
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of grain-derived processed product on visceral fat area
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visceral fat area
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
control: product code;P-001
12-wk repeated consumption and 4-wk post treatment observation.
Dose of 1 serving per day.
Visceral fat area measurement every 4-wk.
Interventions/Control_2
Active: product code;S-001
12-wk repeated consumption and 4-wk post treatment observation.
Dose of 1 serving per day.
Visceral fat area measurement every 4-wk.
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1,25<=BMI<30
2,visceral fat area=>100cm2
3,30<=Age<65 of healthy men and women
4,provided written informed consent from subjects
Key exclusion criteria
1,liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases
2,surgery or therapy within 2 months before the trial
3,medicine user for hyperglycaemia, lipidemia, or hypertension
4,user of supplements or foods with health claim,
5,unpleasant feeling during blood drawing
6,donated 200 mL or more blood within 1 month before the trial
7,skin disease, metal allergy and implanted pacemaker
8,remain constipated 5 days and more
9,changes in weight of 2kg or more within 3 month before the study
10,shift worker
11,business trip and travel planned for 10 consecutive days or more
12,allergies against any constituents in the test diet
13,other clinical study or who intended to participate in one during the study period
14,disagree with explanation for study
15,judged to be inappropriate as subject by physician in charge
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hirona |
| Middle name | |
| Last name | Miura |
Organization
Higashi shinjyuku Clinic
Division name
Director
Zip code
169-0072
Address
1-11-3 Okubo Shinjuku-ku Tokyo
TEL
03-6233-8581
koike@meiseikai-cl.com
Public contact
Name of contact person
| 1st name | Shimpei |
| Middle name | |
| Last name | Tomita |
Organization
New Drug Research Center, Inc.
Division name
Research Division
Zip code
061-1405
Address
452-1, Toiso, Eniwa-shi, Hokkaido
TEL
0123-34-0412
Homepage URL
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
Higashi shinjyuku Clinic
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Miyawaki orthopedics clinic IRB
Address
3-1-6 Ariakecho, Eniwa-city, Hokkaido
Tel
0123-35-3011
d-kameda@mediffom.co.jp
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 | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Unpublished
Result
URL related to results and publications
works in progress
Number of participants that the trial has enrolled
120
Results
There was a significant difference in primary outcome
Results date posted
| 2019 | Year | 07 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
overweight
Participant flow
114 participants completed and 111 subjects were incorporated into the analyses
Adverse events
No adverse effect related to the test diets reported
Outcome measures
visceral fat area
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026735
| 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 |
