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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033280 |
Receipt No. | R000037947 |
Official scientific title of the study | Effect of intake of CoQ10 supplement on fat-burning in young women |
Date of disclosure of the study information | 2018/07/04 |
Last modified on | 2018/07/04 |
Basic information | ||
Official scientific title of the study | Effect of intake of CoQ10 supplement on fat-burning in young women | |
Title of the study (Brief title) | Effect of intake of CoQ10 supplement on fat-burning in young women | |
Region |
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Condition | ||
Condition | Healthy individual | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Verification of fat-burning effect by taking CoQ10 |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Body composition (including weight, body fat, water volume, muscle mass)
Intake for 4 weeks Measurement points: twice, Day 0, Day 28 |
Key secondary outcomes | Visceral adipometer Amount of visceral fat, abdominal circumference
Saliva measurement 1,Cortisol, 2,8-OHdG Skin measurement 1,Water volume, 2,TEWL Questionnaire Life style habit, physical condition, fatigue |
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 | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | No need to know |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | CoQ10 supplement (containing CoQ10 and other diet ingredients)
(Name of constituents) CoQ10, L-carnitine, rose hip extract, blue pepper fermented extract, vitamin B group, and excipients |
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Interventions/Control_2 | Active control (containing CoQ10 but not containing other diet ingredients)
(Constituents) CoQ10, excipients |
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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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | (1) The age at the time of obtaining a consent is 20 years or older.
(2) Female (3) Those from whom a written consent can be obtained on a voluntary basis. |
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Key exclusion criteria | The person who is unsuitable for the entry judged by a officer. | |||
Target sample size | 28 |
Research contact person | |
Name of lead principal investigator | Motoko Takaoka |
Organization | Kobe College |
Division name | School of Human Sciences, Department of Biosphere Sciences |
Address | 4-1 Okadayama, Nhishinomiya-shi, Hyogo pref. 662-8506 Japan |
TEL | 0798-51-8668 |
takaoka@mail.kobe-c.ac.jp |
Public contact | |
Name of contact person | Saki Okumura |
Organization | Noevir Co., Ltd. |
Division name | Groupwide Research and Development |
Address | R&D C Building No. 333, Kanagawa Science park (KSP), 3-2-1 Sakado, Takatsu-ku, Kawasaki-shi, Kanagaw |
TEL | 044-813-2488 |
Homepage URL | |
saki_okumura@n1.noevir.co.jp |
Sponsor | |
Institute | Kobe College |
Institute | |
Department |
Funding Source | |
Organization | Noevir Co., Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
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 | 神戸女学院大学(兵庫県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037947 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |