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
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes
Started Jan 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
December 4, 2015
CompletedStudy Start
First participant enrolled
January 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 14, 2017
March 1, 2017
10 months
November 19, 2015
March 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting glucose
serum level of fasting glucose in mmol/L.
12 weeks
Secondary Outcomes (8)
Low density lipoprotein-cholesterol (LDL-C)
12 weeks
high density lipoprotein-cholesterol (HDL-C)
12 weeks
malondialdehyde (MDA)
12 weeks
catalase (CAT)
12 weeks
superoxide dismutase (SOD)
12 weeks
- +3 more secondary outcomes
Study Arms (2)
Placebo
EXPERIMENTALglycerin.soy-lecithin, and water
Supplement
EXPERIMENTALwater-soluble Ubiquinol 100 mg/d
Interventions
100 mg/d
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yehlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ping-Ting Lin, Ph.D.
School of Nutrition, Chung Shan Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 19, 2015
First Posted
December 4, 2015
Study Start
January 4, 2016
Primary Completion
October 25, 2016
Study Completion
March 1, 2017
Last Updated
March 14, 2017
Record last verified: 2017-03