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 |
Effect of a plant-derived processed product on visceral fat area
Effect of a plant-derived processed product on visceral fat area
Effect of a plant-derived processed product on visceral fat area
Effect of a plant-derived processed product on visceral fat area
Japan |
healthy humans
Adult |
Others
NO
To investigate the effect of plant-derived processed product on visceral fat area
Efficacy
visceral fat area
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
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
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
35 | years-old | <= |
65 | years-old | > |
Male and Female
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
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
126
1st name | Atsuko |
Middle name | |
Last name | Mori |
Oriental Ueno Kenshin Center
Head of center
110-0005
1-20-11 Ueno Taito-ku Tokyo 110-0005
03-5816-0711
ueno-center@oriental-gr.com
1st name | Toshiyasu |
Middle name | |
Last name | Tamura |
TES Holdings Co. Ltd
Sales Department of Regenerative Medicine and Clinical Trials
103-0027
6F Univ. of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
03-6801-8480
t.tamura@tes-h.co.jp
Oriental Ueno Kenshin Center
Health Care Food Research Laboratories, Kao Corporation
Profit organization
the Ethical Committee of the Oriental Ueno Kenshin Center
421-1, Zitoukata, Ugeo City
03-5816-0711
ueno-center@oriental-gr.com
NO
2016 | Year | 05 | Month | 10 | Day |
Unpublished due to the protocol including the intellectual property rights
Published
http://onlinelibrary.wiley.com/doi/10.1002/oby.21938/epdf
114
Significant difference in the primary outcome between the groups
2019 | Year | 07 | Month | 25 | Day |
overweight and obesity
126 were screened and 114 were analyzed
None associated with the test diets consumption
visceral fat area
Main results already published
2016 | Year | 04 | Month | 18 | Day |
2016 | Year | 04 | Month | 18 | Day |
2016 | Year | 05 | Month | 30 | Day |
2017 | Year | 12 | Month | 17 | Day |
2016 | Year | 04 | Month | 18 | Day |
2019 | Year | 07 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025166