DiabetesPhase 2/3NCT02622672
Water-soluble Ubiquinol Supplementation on Blood Glucose, Lipids, Oxidative Stress, and Inflammation in Diabetes
A Phase 2/3 study testing water-soluble ubiquinol in people with Diabetes, run by Yeh.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- water-soluble ubiquinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2016to 1 Mar 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
About this study
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
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- water-soluble ubiquinol, Placebo
- Keywords
- Antioxidation, Anti-inflammation, Blood glucose, Blood lipids
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water-soluble ubiquinolDietary supplement
Also called water-soluble coenzyme Q10
100 mg/d
PlaceboDietary supplement
glycerin.soy-lecithin, and water
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | glycerin.soy-lecithin, and water Receives: Dietary Supplement: Placebo |
| Supplement | Experimental | water-soluble Ubiquinol 100 mg/d Receives: Dietary Supplement: water-soluble ubiquinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
serum level of fasting glucose in mmol/L.
Measured: 12 weeks
Secondary outcomes (8)
Low density lipoprotein-cholesterol (LDL-C)
serum level of LDL-C in mmol/L.
Measured: 12 weeks
high density lipoprotein-cholesterol (HDL-C)
serum level of HDL-C in mmol/L.
Measured: 12 weeks
malondialdehyde (MDA)
plasma level of MDA in micromol/L.
Measured: 12 weeks
catalase (CAT)
red blood cells level of CAT in Units/mg protein.
Measured: 12 weeks
superoxide dismutase (SOD)
red blood cells level of SOD in Units/mg protein.
Measured: 12 weeks
glutathione peroxidase (GPx)
red blood cells level of GPx in Units/mg protein.
Measured: 12 weeks
high sensitivity C-reactive protein (hs-CRP)
serum level of hs-CRP in mg/L.
Measured: 12 weeks
high sensitivity interleukin (hs-IL-6)
serum level of hs-IL-6 in pg/mL.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start4 Jan 2016
- Primary completion25 Oct 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yeh, Chung Shan Medical University
- Investigators
- Ping-Ting Lin, Ph.D., Principal investigator, School of Nutrition, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622672
- Sponsor's protocol ID
- CS2-15095
- Status last verified
- Mar 2017
- First submitted
- 19 Nov 2015
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02622672
- Acronym / sponsor ID
- CS2-15095
- Conditions
- Diabetes
- Keywords
- Antioxidation, Anti-inflammation, Blood glucose, Blood lipids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- YehUniversity, hospital or other
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Dietary Supplement: Placeboglycerin.soy-lecithin, and water |
| Supplement | Experimental | Dietary Supplement: water-soluble ubiquinolwater-soluble Ubiquinol 100 mg/d |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water-soluble ubiquinolAlso: water-soluble coenzyme Q10100 mg/d | Dietary supplement | Supplement |
| Placeboglycerin.soy-lecithin, and water | Dietary supplement | Placebo |
Primary outcome
Fasting glucose
Time frame: 12 weeks
serum level of fasting glucose in mmol/L.
8 secondary outcomes
Low density lipoprotein-cholesterol (LDL-C)
Time frame: 12 weeks
high density lipoprotein-cholesterol (HDL-C)
Time frame: 12 weeks
malondialdehyde (MDA)
Time frame: 12 weeks
catalase (CAT)
Time frame: 12 weeks
superoxide dismutase (SOD)
Time frame: 12 weeks
glutathione peroxidase (GPx)
Time frame: 12 weeks
high sensitivity C-reactive protein (hs-CRP)
Time frame: 12 weeks
high sensitivity interleukin (hs-IL-6)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-Ting Lin, Ph.D. principal investigator
School of Nutrition, Chung Shan Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing water-soluble ubiquinol in people with Diabetes, run by Yeh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.