Unique ID issued by UMIN | UMIN000030882 |
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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 |
Anti-fatigue effect of coenzyme Q10 and R-alpha-lipoic acid against physical work: randomized, double-blinded, cross-over clinical trial.
Anti-fatigue effect of coenzyme Q10 and R-alpha-lipoic acid
Anti-fatigue effect of coenzyme Q10 and R-alpha-lipoic acid against physical work: randomized, double-blinded, cross-over clinical trial.
Anti-fatigue effect of coenzyme Q10 and R-alpha-lipoic acid
Japan |
healthy subjects
Adult |
Others
NO
Clinical study to evaluate anti-fatigue effects of long-term oral intake of coenzyme Q10 and R-alpha-lipoic acid.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
10 seconds high power test using bicycle ergometer.
Physical Working Capacity (PWC) test, Blood test, autonomic nervous, VAS, Chalder, d-ROMs, BAP, Blood coenzyme Q10 level, Blood alpha-lipoic acid level.
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Food |
Orally intake test Jelly (coenzyme Q10 and R-alpha-lipoic acid) twice a day for 4 weeks.
Orally intake placebo jelly twice a day for 4 weeks.
30 | years-old | <= |
60 | years-old | >= |
Male and Female
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.
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.
24
1st name | |
Middle name | |
Last name | Norihiro Sakamoto |
Kobe University
Graduate School of Medicine
7-5-2 Kusunoki-cho Chuo-ku, Kobe, Hyogo 650-0017, Japan
078-382-5777
nori@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Naoko Ikuta |
Kobe University
Graduate School of Medicine
7-5-2 Kusunoki-cho Chuo-ku, Kobe, Hyogo 650-0017, Japan
078-382-5777
naoko.ikuta@people.kobe-u.ac.jp
Kobe University
CycloChem Co., Ltd.
Profit organization
NO
医療法人弘正会ふくだ内科クリニック
2018 | Year | 01 | Month | 19 | Day |
Unpublished
Preinitiation
2017 | Year | 12 | Month | 05 | Day |
2018 | Year | 01 | Month | 06 | Day |
2018 | Year | 01 | Month | 18 | Day |
2018 | Year | 01 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031183
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