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

Phase 2

Completed

• Conditions: Diabetes
• Interventions: Dietary Supplement: water-soluble ubiquinol; Dietary Supplement: Placebo

• Registration Number: NCT02622672
• Lead Sponsor: Yeh

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.

Study Timeline

• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Study Start: 2016-01-04
• Primary Completion: 2016-10-25
• Status Verified: 2017-03
• Study Completion: 2017-03-01
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplement	water-soluble ubiquinol	water-soluble Ubiquinol 100 mg/d
Placebo	Placebo	glycerin.soy-lecithin, and water

Primary Outcome Measures

Name	Time	Method
Fasting glucose	12 weeks	serum level of fasting glucose in mmol/L.

Secondary Outcome Measures

Name	Time	Method
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.
glutathione peroxidase (GPx)	12 weeks	red blood cells level of GPx in Units/mg protein.
high sensitivity interleukin (hs-IL-6)	12 weeks	serum level of hs-IL-6 in pg/mL.
Low density lipoprotein-cholesterol (LDL-C)	12 weeks	serum level of LDL-C in mmol/L.
high density lipoprotein-cholesterol (HDL-C)	12 weeks	serum level of HDL-C in mmol/L.
superoxide dismutase (SOD)	12 weeks	red blood cells level of SOD in Units/mg protein.
high sensitivity C-reactive protein (hs-CRP)	12 weeks	serum level of hs-CRP in mg/L.