UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030882
Receipt number 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 18:16:38

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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 or person

Institute

Kobe University

Institute

Department

Personal name



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

Value
https://center6.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