Diabetes
Conditions
Keywords
Antioxidation, Anti-inflammation, Blood glucose, Blood lipids
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTwater-soluble ubiquinol
100 mg/d
DIETARY_SUPPLEMENTPlacebo
glycerin.soy-lecithin, and water
Sponsors
Yeh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose | 12 weeks | serum level of fasting glucose in mmol/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| high density lipoprotein-cholesterol (HDL-C) | 12 weeks | serum level of HDL-C in mmol/L. |
| malondialdehyde (MDA) | 12 weeks | plasma level of MDA in micromol/L. |
| catalase (CAT) | 12 weeks | red blood cells level of CAT in Units/mg protein. |
| Low density lipoprotein-cholesterol (LDL-C) | 12 weeks | serum level of LDL-C in mmol/L. |
| glutathione peroxidase (GPx) | 12 weeks | red blood cells level of GPx in Units/mg protein. |
| high sensitivity C-reactive protein (hs-CRP) | 12 weeks | serum level of hs-CRP in mg/L. |
| high sensitivity interleukin (hs-IL-6) | 12 weeks | serum level of hs-IL-6 in pg/mL. |
| superoxide dismutase (SOD) | 12 weeks | red blood cells level of SOD in Units/mg protein. |
Outcome results
None listed