Water-soluble Ubiquinol Supplementation on Blood Glucose, Lipids, Oxidative Stress, and Inflammation in Diabetes

Study Overview
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Brief Summary
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Diabetes is considered an oxidative stress and a chronic inflammatory disease. Coenzyme Q10 (ubiquinone) is recognized as a lipid soluble antioxidant. Ubiquinol is a reduced form of coenzyme Q10 in our body after food or supplements intakes. Studies have indicated that the water-soluble ubiquinol had better antioxidant activity and absorption than lipid-soluble. The purpose of this study was to investigate the effects of a water-soluble ubiquinol supplement (100 mg/d) on antioxidation and anti-inflammation in diabetes patients.

Detailed Description
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The patients with type 2 diabetes will recruit as subjects (n = 50) and randomly assign to the placebo (n = 25) or coenzyme Q10 groups (n = 25). The intervention will administer for 12 weeks. The concentrations of coenzyme Q10, oxidative stress marker (malondialdehyde), antioxidant enzymes activities (superoxide dismutase, catalase, and glutathione peroxidase), inflammatory markers [C-reactive protein (CRP), and interleukin-6 (IL-6)], and biochemical parameters (fasting glucose, A1C, insulin, C-peptide, and lipid profiles), and blood pressure will measure. Hopefully, the results of this study could provide the information of water-soluble ubiquinol supplement for clinical doctors and dietitians recommend that diabetes patients deserve to know whether the use of coenzyme Q10 supplement.

Official Title
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Water-soluble Ubiquinol (a Reduced Form of Coenzyme Q10) Supplementation on Blood Glucose, Lipids, Oxidative Stress, and Inflammation in Patients With Type 2 Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Dietary Supplement: water-soluble ubiquinol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnostic criteria for type 2 diabetes were defined as a glycohemoglobin (A1C) ≧ 6.5%, a fasting glucose ≧ 7.0 mmol/L or a 2-h plasma glucose ≧ 200 mmol/L during an oral glucose tolerance test (OGTT), as well as the use of anti-hyperglycemic drugs. Exclusion Criteria: pregnant or lactation women. patients with liver or renal disease Antioxidant dietary supplements user. patients under warfarin therapy. patients with hypoglycemia (fasting glucose < 60 mg/dL) or hyperlipidemia (fasting triglyceride ≧ 500 mg/dL)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>glycerin.soy-lecithin, and water | Dietary Supplement: Placebo<br>* glycerin.soy-lecithin, and water<br>|
| Experimental: Supplement<br>water-soluble Ubiquinol 100 mg/d | Dietary Supplement: water-soluble ubiquinol<br>* 100 mg/d<br>* Other names: water-soluble coenzyme Q10;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose | serum level of fasting glucose in mmol/L. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoprotein-cholesterol (LDL-C) | serum level of LDL-C in mmol/L. | 12 weeks | 
| high density lipoprotein-cholesterol (HDL-C) | serum level of HDL-C in mmol/L. | 12 weeks | 
| malondialdehyde (MDA) | plasma level of MDA in micromol/L. | 12 weeks | 
| catalase (CAT) | red blood cells level of CAT in Units/mg protein. | 12 weeks | 
| superoxide dismutase (SOD) | red blood cells level of SOD in Units/mg protein. | 12 weeks | 
| glutathione peroxidase (GPx) | red blood cells level of GPx in Units/mg protein. | 12 weeks | 
| high sensitivity C-reactive protein (hs-CRP) | serum level of hs-CRP in mg/L. | 12 weeks | 
| high sensitivity interleukin (hs-IL-6) | serum level of hs-IL-6 in pg/mL. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antioxidation, Anti-inflammation, Blood glucose, Blood lipids