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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

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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
Japan

Condition
Condition Healthy individual
Classification by specialty
Adult
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
Food
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
Interventions/Control_2 Active control (containing CoQ10 but not containing other diet ingredients)
(Constituents) CoQ10, excipients
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
20 years-old <=
Age-upper limit

Not applicable
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.
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
Email 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
Email 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
2018 Year 07 Month 04 Day

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 04 Month 26 Day
Anticipated trial start date
2018 Year 06 Month 04 Day
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
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 04 Day


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


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