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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-04

Study Completion Date

2017-03-01

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.

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo

glycerin.soy-lecithin, and water

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

glycerin.soy-lecithin, and water

Supplement

water-soluble Ubiquinol 100 mg/d

Group Type EXPERIMENTAL

water-soluble ubiquinol

Intervention Type DIETARY_SUPPLEMENT

100 mg/d

Interventions

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water-soluble ubiquinol

100 mg/d

Intervention Type DIETARY_SUPPLEMENT

Placebo

glycerin.soy-lecithin, and water

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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water-soluble coenzyme Q10

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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No