healthy subjects
Conditions
Interventions
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.
Sponsors
Kobe University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 10 seconds high power test using bicycle ergometer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical Working Capacity (PWC) test, Blood test, autonomic nervous, VAS, Chalder, d-ROMs, BAP, Blood coenzyme Q10 level, Blood alpha-lipoic acid level. | — |
Countries
Japan
Contacts
Public ContactNaoko Ikuta
Kobe University Graduate School of Medicine
Outcome results
None listed