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

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

Study Overview

• Status: Completed
• Conditions: CoQ10 Blood Levels; CoQ10 Blood Levels With Statin Use
• Intervention / Treatment: Dietary supplement: Omega Q Plus Resveratrol (with 50mg CoQ10)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the blood levels of Coenzyme Q10 in healthy subjects when administered Omega Q Plus® Resveratrol for 28 days.	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in blood levels of Coenzyme Q10 at 28 days	28 days

Other Outcome Measures

Outcome Measure	Time Frame
Change from,14 days prior to Baseline, in safety blood chemistry parameters (glucose, creatinine, AST, ALT, GGT, bilirubin) at 28 days	42 days
Change from,14 days prior to Baseline, in vital signs at 28 days	42 days
Number of Participants with Adverse Events	42 days
Change from,14 days prior to Baseline, in hematology parameters (CBC, electrolytes) to 28 days	42 days

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: Healthy Directions, LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 3, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Statin; Resveratrol; Coenzyme Q10
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: 15COHH