UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021970 |
|---|---|
| Receipt number | R000025166 |
| Scientific Title | Effect of a plant-derived processed product on visceral fat area |
| Date of disclosure of the study information | 2016/05/10 |
| Last modified on | 2019/07/25 13:59:13 |
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Basic information
Public title
Effect of a plant-derived processed product on visceral fat area
Acronym
Effect of a plant-derived processed product on visceral fat area
Scientific Title
Effect of a plant-derived processed product on visceral fat area
Scientific Title:Acronym
Effect of a plant-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 plant-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
12-wk repeated consumption of control product (product code A-001), visceral fat area measurement every 4wk, pre-treatment observation period (4wk), post-treatment observation period (4wk) , dose of 1 serving per day
Interventions/Control_2
12-wk repeated consumption of test product (product code B-001), visceral fat area measurement every 4wk, pre-treatment observation period (4wk), post-treatment observation period (4wk), dose of 1 serving per day
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1,25<=BMI<30, 2,visceral fat area=>120cm2, 3,35<=Age<65 of men and postmenopausal women, 4,provides informed consent in a documented form
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,changed weight 2 kg or more within 1 month before the trial, 8,shiftworker, 9,plans business trip for 10 consecutive days or more, 10, allergy against any constituents in the test diet, 11, participant in the other trial or plan to be, 12, cannot provide informed consent, 13, judged to be inappropriate as subject by physician in charge
Target sample size
126
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Mori |
Organization
Oriental Ueno Kenshin Center
Division name
Head of center
Zip code
110-0005
Address
1-20-11 Ueno Taito-ku Tokyo 110-0005
TEL
03-5816-0711
ueno-center@oriental-gr.com
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Tamura |
Organization
TES Holdings Co. Ltd
Division name
Sales Department of Regenerative Medicine and Clinical Trials
Zip code
103-0027
Address
6F Univ. of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
03-6801-8480
Homepage URL
t.tamura@tes-h.co.jp
Sponsor or person
Institute
Oriental Ueno Kenshin Center
Institute
Department
Personal name
Funding Source
Organization
Health Care Food Research Laboratories, 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
the Ethical Committee of the Oriental Ueno Kenshin Center
Address
421-1, Zitoukata, Ugeo City
Tel
03-5816-0711
ueno-center@oriental-gr.com
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 | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1002/oby.21938/epdf
Number of participants that the trial has enrolled
114
Results
Significant difference in the primary outcome between the groups
Results date posted
| 2019 | Year | 07 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
overweight and obesity
Participant flow
126 were screened and 114 were analyzed
Adverse events
None associated with the test diets consumption
Outcome measures
visceral fat area
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 17 | 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 | 04 | Month | 18 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025166
