Clinical Drug Experience Knowledgebase

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