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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: water-soluble ubiquinol

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; glycerin.soy-lecithin, and water	Dietary supplement: Placebo; glycerin.soy-lecithin, and water
Experimental: Supplement; water-soluble Ubiquinol 100 mg/d	Dietary supplement: water-soluble ubiquinol; 100 mg/d; Other Names: water-soluble coenzyme Q10

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yeh
• Investigators: Principal Investigator: Ping-Ting Lin, Ph.D., School of Nutrition, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2016
• Primary Completion (Actual): October 25, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Blood glucose; Blood lipids; Antioxidation; Anti-inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Inflammation; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10
• Other Study ID Numbers: CS2-15095