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Completed

NCT Number: NCT02622672

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

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Water-soluble Ubiquinol

Dietary Supplement

100 mg/d

Other names: water-soluble coenzyme Q10

Placebo

Dietary Supplement

glycerin.soy-lecithin, and water

Primary outcomes

  1. Fasting glucose

    Time frame: 12 weeks

    serum level of fasting glucose in mmol/L.

Secondary outcomes

  1. Low density lipoprotein-cholesterol (LDL-C)

    Time frame: 12 weeks

    serum level of LDL-C in mmol/L.

  2. high density lipoprotein-cholesterol (HDL-C)

    Time frame: 12 weeks

    serum level of HDL-C in mmol/L.

  3. malondialdehyde (MDA)

    Time frame: 12 weeks

    plasma level of MDA in micromol/L.

  4. catalase (CAT)

    Time frame: 12 weeks

    red blood cells level of CAT in Units/mg protein.

  5. superoxide dismutase (SOD)

    Time frame: 12 weeks

    red blood cells level of SOD in Units/mg protein.

  6. glutathione peroxidase (GPx)

    Time frame: 12 weeks

    red blood cells level of GPx in Units/mg protein.

  7. high sensitivity C-reactive protein (hs-CRP)

    Time frame: 12 weeks

    serum level of hs-CRP in mg/L.

  8. high sensitivity interleukin (hs-IL-6)

    Time frame: 12 weeks

    serum level of hs-IL-6 in pg/mL.

Sponsors and collaborators

Lead sponsor

Yeh

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Dec 4, 2015
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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