CoQ10 Blood LevelsPhase 1NCT02415114
An Open Label Study Evaluating the Effectiveness of Omega Q Plus® Resveratrol at Increasing Blood Levels of CoQ10
A Phase 1 study testing Omega Q Plus Resveratrol (with 50mg CoQ10) in people with CoQ10 Blood Levels and CoQ10 Blood Levels With Statin Use, run by KGK Science Inc. at 1 site in Canada.
Trial summary
The primary objective of this study is to assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days.The secondary objective of the study is to determine if statin use has an impact on the blood levels of Coenzyme Q10 when administered Omega Q Plus® Resveratrol… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- CoQ10 Blood Levels, CoQ10 Blood Levels With Statin Use
- What is being tested?
- Omega Q Plus Resveratrol (with 50mg CoQ10)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Jun 2015
- Phase
- Phase 1
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 45 years of age or older
- BMI <30kg/m2 (±1 kg/m2)
- If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
- OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System). Double-barrier method. Non-hormonal intrauterine devices. Vasectomy of partner. Non-heterosexual lifestyle (same-sex relationship).
- CoQ10 levels between 0.5 mcg/mL - 1 mcg/mL
- Agree to maintain current level of physical activity, caffeine consumption habits, alcohol consumption habits, smoking habits and dietary habits throughout the study
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- Has given voluntary, written, informed consent to participate in the study
- Adults on statin medications for at least 3 months and are otherwise healthy
- Male or female 45 years of age or older
- BMI <30kg/m2 (±1 kg/m2)
- If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
- OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System). Double-barrier method. Non-hormonal intrauterine devices. Vasectomy of partner.Non-heterosexual lifestyle (same-sex relationship)
- Agree to maintain current level of physical activity, caffeine consumption habits, alcohol consumption habits, smoking habits and dietary habits throughout the study
- Has given voluntary, written, informed consent to participate in the study
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Unstable medical conditions
- History of atrial or ventricular arrhythmia
- History of atherosclerosis
- History of seizures
- Type I or Type II diabetes
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- Use of illicit drugs or history of alcohol or drug abuse within the last 6 months
- Currently having more than 2 standard alcoholic drinks per day
- Medical use of marijuana
- Clinically significant abnormal laboratory results at screening
- History or a current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subject with cancer in full remission more than 5 years after diagnosis are acceptable
- Use of prescription blood thinner medications (i.e. warfarin etc.)
- Use of products containing CoQ10 other than vitamins or minerals within 2 weeks of randomization
- Uncontrolled hypertension defined as untreated systolic blood pressure >160 mmHg or/or diastolic blood pressure >100mmHg
- Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
- Significant abnormal liver function as defined as AST or/ALT > 2 times the upper limit of normal (ULN), and/or bilirubin > 2 times the ULN
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study supplement ingredients
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Conditions that in the opinion of the investigator may suggest that the subject may be unsuitable for this study
- Unstable medical conditions
- Use of illicit drugs or history of alcohol or drug abuse within the last 6 months
- Currently having more than 2 standard alcoholic drinks per day
- Medical use of marijuana
- Clinically significant abnormal laboratory results at screening (except elevated levels of creatinine kinase that will be considered based on the opinion of the Investigator)
- History or a current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subject with cancer in full remission more than 5 years after diagnosis are acceptable
- History of muscle disease unrelated to statin use
- History of seizures
- Any acute disease that may influence plasma CoQ10 levels
- Subjects on background CoQ10 therapy during the last 3 months
- Use of products containing CoQ10 other than vitamins or minerals within 2 weeks of randomization
- Uncontrolled hypertension defined as untreated systolic blood pressure >160 mmHg or/or diastolic blood pressure >100mmHg
- Use of prescription blood thinner medications (i.e. warfarin etc.)
- Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
- Significant abnormal liver function as defined as AST or/ALT > 2 times the upper limit of normal (ULN), and/or bilirubin > 2 times the ULN
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study supplement ingredients
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Pilot Study to Evaluate the Effectiveness of Omega Q Plus® Resveratrol at Increasing Blood Levels of CoQ10 in Healthy Subjects and Subjects on Statins
The primary objective of this study is to assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days.The secondary objective of the study is to determine if statin use has an impact on the blood levels of Coenzyme Q10 when administered Omega Q Plus® Resveratrol for 28 days. The safety objectives will include assessment of safety evaluations as determined by:
- laboratory tests - CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin
- vital signs - heart rate and blood pressure
- adverse events
- Being tested
- Omega Q Plus Resveratrol (with 50mg CoQ10)
- Keywords
- Coenzyme Q10, Resveratrol, Statin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega Q Plus Resveratrol (with 50mg CoQ10)Dietary supplement
Omega Q Plus Resveratrol (with 50mg CoQ10)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Population | Active comparator | Healthy Population with Omega Q Plus Resveratrol (with 50mg CoQ10) Receives: Dietary Supplement: Omega Q Plus Resveratrol (with 50mg CoQ10) |
| Population taking Statins | Active comparator | Population taking Statins with Omega Q Plus Resveratrol (with 50mg CoQ10) Receives: Dietary Supplement: Omega Q Plus Resveratrol (with 50mg CoQ10) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days.
Measured: 28 days
Secondary outcomes (1)
Change from Baseline in blood levels of Coenzyme Q10 at 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoQ10 Blood LevelsStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Healthy Directions, LLC
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415114
- Sponsor's protocol ID
- 15COHH
- Status last verified
- Sep 2015
- First submitted
- 3 Mar 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study to Evaluate the Effectiveness of Omega Q Plus® Resveratrol at Increasing Blood Levels of CoQ10 in Healthy Subjects and Subjects on Statins
- ClinicalTrials.gov ID
- NCT02415114
- Acronym / sponsor ID
- 15COHH
- Keywords
- Coenzyme Q10, Resveratrol, Statin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Healthy Directions, LLC
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Apr 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.
The primary objective of this study is to assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days.The secondary objective of the study is to determine if statin use has an impact on the blood levels of Coenzyme Q10 when administered Omega Q Plus® Resveratrol for 28 days. The safety objectives will include assessment of safety evaluations as determined by:
- laboratory tests - CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin
- vital signs - heart rate and blood pressure
- adverse events
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Population | Active comparator | Dietary Supplement: Omega Q Plus Resveratrol (with 50mg CoQ10)Healthy Population with Omega Q Plus Resveratrol (with 50mg CoQ10) |
| Population taking Statins | Active comparator | Dietary Supplement: Omega Q Plus Resveratrol (with 50mg CoQ10)Population taking Statins with Omega Q Plus Resveratrol (with 50mg CoQ10) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female 45 years of age or older
- BMI <30kg/m2 (±1 kg/m2)
- If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
- OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System). Double-barrier method. Non-hormonal intrauterine devices. Vasectomy of partner. Non-heterosexual lifestyle (same-sex relationship).
- CoQ10 levels between 0.5 mcg/mL - 1 mcg/mL
Key exclusion criteria (41 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Unstable medical conditions
- History of atrial or ventricular arrhythmia
- History of atherosclerosis
- History of seizures
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 |
|---|---|---|
| Omega Q Plus Resveratrol (with 50mg CoQ10)Omega Q Plus Resveratrol (with 50mg CoQ10) | Dietary supplement | Healthy Population, Population taking Statins |
Primary outcome
To assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days.
Time frame: 28 days
1 secondary outcome
Change from Baseline in blood levels of Coenzyme Q10 at 28 days
Time frame: 28 days
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 23 Sep 2015.
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.
Tetyana Pelipyagina, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omega Q Plus Resveratrol (with 50mg CoQ10) in people with CoQ10 Blood Levels and CoQ10 Blood Levels With Statin Use, run by KGK Science Inc. at 1 site in Canada.
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 14 inclusion and 41 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 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days. (time frame: 28 days). 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 23 Sep 2015.