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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030882
Receipt No. R000031183
Scientific Title Anti-fatigue effect of coenzyme Q10 and R-alpha-lipoic acid against physical work: randomized, double-blinded, cross-over clinical trial.
Date of disclosure of the study information 2018/01/19
Last modified on 2018/01/18

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Basic information
Public title Anti-fatigue effect of coenzyme Q10 and R-alpha-lipoic acid against physical work: randomized, double-blinded, cross-over clinical trial.
Acronym Anti-fatigue effect of coenzyme Q10 and R-alpha-lipoic acid
Scientific Title Anti-fatigue effect of coenzyme Q10 and R-alpha-lipoic acid against physical work: randomized, double-blinded, cross-over clinical trial.
Scientific Title:Acronym Anti-fatigue effect of coenzyme Q10 and R-alpha-lipoic acid
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical study to evaluate anti-fatigue effects of long-term oral intake of coenzyme Q10 and R-alpha-lipoic acid.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 10 seconds high power test using bicycle ergometer.
Key secondary outcomes Physical Working Capacity (PWC) test, Blood test, autonomic nervous, VAS, Chalder, d-ROMs, BAP, Blood coenzyme Q10 level, Blood alpha-lipoic acid level.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Orally intake test Jelly (coenzyme Q10 and R-alpha-lipoic acid) twice a day for 4 weeks.
Interventions/Control_2 Orally intake placebo jelly twice a day for 4 weeks.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Subject who gives a written informed consent and being between an age of 30 to 60, being Japanese, being non-smoker, being in good health and physical condition.
Key exclusion criteria 1)receiving medical treatment or having a history or suspicion of diabetes, liver disease, kidney disease, heart disease, lung disease, endocrine disease, metabolic disease, or other grave diseases.
2)being a CFS (chronic fatigue syndrome) patient or having severe fatigue such as idiopathic chronic fatigue as determined by investigators.
3)having a history of chest pain or fainting.
4)having abnormal electrocardiogram.
5)having back pain, joint pain, disc hernia, leg pain or a palpitation.
6)having a food allergy or a drug allergy.
7)taking supplemental coenzyme Q10 and alpha-lipoic acid.
8)taking a drug or a functional food for recovery from fatigue or supplementation for muscle fatigue.
9)taking drugs which could affect test results such as cholesterol-lowering-drug, triglyceride lowering drug, blood pressure drug, blood glucose lowering drug, and so on, or having taken these drugs within the past one month, or need to take these drug during the test period.
10)taking alcohol of 60g/day and more and cannot keep abstinence from the day before the Visit to the end of the Visit.
11)having blood drawn of over 200mL within one month or over 400mL within 3 month before this study starts.
12)a person who is pregnant, or having a possibility to be pregnant or of breast-feeding during the test period or within 2 weeks after the end of the study.
13)being a participant of other clinical study at the start of this study or having its possibility.
14)being a participant of other clinical study within the past 3 months.
15)having a LDL level of 160 mg/dL and over.
16)having a fasting triglyceride level of 200 mg/dL and over.
17)having a fasting blood glucose level of 126 mg/dL and over.
18)having a systolic blood pressure of 160mmHg and over, or having a diastolic blood pressure of 100mmHg and over.
19)Being included significant clinical deviation from normal as determined by investigators.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Sakamoto
Organization Kobe University
Division name Graduate School of Medicine
Zip code
Address 7-5-2 Kusunoki-cho Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL 078-382-5777
Email nori@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Ikuta
Organization Kobe University
Division name Graduate School of Medicine
Zip code
Address 7-5-2 Kusunoki-cho Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL 078-382-5777
Homepage URL
Email naoko.ikuta@people.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization CycloChem Co., Ltd.
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
Address
Tel
Email

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 医療法人弘正会ふくだ内科クリニック

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 18 Day
Last modified on
2018 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031183

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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