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An Open Label Study Evaluating the Effectiveness of Omega Q Plus® Resveratrol at Increasing Blood Levels of CoQ10

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ClinicalTrials.gov Identifier: NCT02415114
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Healthy Directions, LLC
Information provided by (Responsible Party):
KGK Science Inc.

Brief 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 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

Condition or disease Intervention/treatment Phase
CoQ10 Blood Levels CoQ10 Blood Levels With Statin Use Dietary Supplement: Omega Q Plus Resveratrol (with 50mg CoQ10) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : March 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Healthy Population
Healthy Population with Omega Q Plus Resveratrol (with 50mg CoQ10)
Dietary Supplement: Omega Q Plus Resveratrol (with 50mg CoQ10)
Omega Q Plus Resveratrol (with 50mg CoQ10)

Active Comparator: Population taking Statins
Population taking Statins with Omega Q Plus Resveratrol (with 50mg CoQ10)
Dietary Supplement: Omega Q Plus Resveratrol (with 50mg CoQ10)
Omega Q Plus Resveratrol (with 50mg CoQ10)




Primary Outcome Measures :
  1. To assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Change from Baseline in blood levels of Coenzyme Q10 at 28 days [ Time Frame: 28 days ]

Other Outcome Measures:
  1. Change from,14 days prior to Baseline, in safety blood chemistry parameters (glucose, creatinine, AST, ALT, GGT, bilirubin) at 28 days [ Time Frame: 42 days ]
  2. Change from,14 days prior to Baseline, in vital signs at 28 days [ Time Frame: 42 days ]
  3. Number of Participants with Adverse Events [ Time Frame: 42 days ]
  4. Change from,14 days prior to Baseline, in hematology parameters (CBC, electrolytes) to 28 days [ Time Frame: 42 days ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for healthy adults

  • 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
  • Has given voluntary, written, informed consent to participate in the study

Inclusion criteria for adults on statin medications

  • 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

Exclusion Criteria:

Exclusion criteria for healthy adults

  • 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
  • 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

Exclusion criteria for adults on statins

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415114


Locations
Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
KGK Science Inc.
Healthy Directions, LLC
Investigators
Principal Investigator: Tetyana Pelipyagina, MD KGK Science Inc.

Responsible Party: KGK Science Inc.
ClinicalTrials.gov Identifier: NCT02415114     History of Changes
Other Study ID Numbers: 15COHH
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by KGK Science Inc.:
Coenzyme Q10
Resveratrol
Statin

Additional relevant MeSH terms:
Resveratrol
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coenzyme Q10
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Protective Agents
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents
Vitamins
Micronutrients
Growth Substances