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

Primary Purpose

Diabetes

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

water-soluble ubiquinol

Placebo

About this trial

This is an interventional supportive care trial for Diabetes focused on measuring Antioxidation, Anti-inflammation, Blood glucose, Blood lipids

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Placebo

Supplement

Arm Description

glycerin.soy-lecithin, and water

water-soluble Ubiquinol 100 mg/d

Outcomes

Primary Outcome Measures

Fasting glucose

serum level of fasting glucose in mmol/L.

Secondary Outcome Measures

Low density lipoprotein-cholesterol (LDL-C)

serum level of LDL-C in mmol/L.

high density lipoprotein-cholesterol (HDL-C)

serum level of HDL-C in mmol/L.

malondialdehyde (MDA)

plasma level of MDA in micromol/L.

catalase (CAT)

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

superoxide dismutase (SOD)

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

glutathione peroxidase (GPx)

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

high sensitivity C-reactive protein (hs-CRP)

serum level of hs-CRP in mg/L.

high sensitivity interleukin (hs-IL-6)

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

Full Information

NCT ID

NCT02622672

First Posted

November 19, 2015

Last Updated

March 13, 2017

Sponsor

Yeh

1. Study Identification

Unique Protocol Identification Number

NCT02622672

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 4, 2016 (Actual)

Primary Completion Date

October 25, 2016 (Actual)

Study Completion Date

March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yeh

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes

Keywords

Antioxidation, Anti-inflammation, Blood glucose, Blood lipids

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Experimental

Arm Description

glycerin.soy-lecithin, and water

Arm Title

Supplement

Arm Type

Experimental

Arm Description

water-soluble Ubiquinol 100 mg/d

Intervention Type

Dietary Supplement

Intervention Name(s)

water-soluble ubiquinol

Other Intervention Name(s)

water-soluble coenzyme Q10

Intervention Description

100 mg/d

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

glycerin.soy-lecithin, and water

Primary Outcome Measure Information:

Title

Fasting glucose

Description

serum level of fasting glucose in mmol/L.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Low density lipoprotein-cholesterol (LDL-C)

Description

serum level of LDL-C in mmol/L.

Time Frame

12 weeks

Title

high density lipoprotein-cholesterol (HDL-C)

Description

serum level of HDL-C in mmol/L.

Time Frame

12 weeks

Title

malondialdehyde (MDA)

Description

plasma level of MDA in micromol/L.

Time Frame

12 weeks

Title

catalase (CAT)

Description

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

Time Frame

12 weeks

Title

superoxide dismutase (SOD)

Description

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

Time Frame

12 weeks

Title

glutathione peroxidase (GPx)

Description

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

Time Frame

12 weeks

Title

high sensitivity C-reactive protein (hs-CRP)

Description

serum level of hs-CRP in mg/L.

Time Frame

12 weeks

Title

high sensitivity interleukin (hs-IL-6)

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ping-Ting Lin, Ph.D.

Organizational Affiliation

School of Nutrition, Chung Shan Medical University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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