CoQ10 Blood Levels, CoQ10 Blood Levels With Statin Use
Conditions
Keywords
Coenzyme Q10, Resveratrol, Statin
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
Interventions
DIETARY_SUPPLEMENTOmega Q Plus Resveratrol (with 50mg CoQ10)
Omega Q Plus Resveratrol (with 50mg CoQ10)
Sponsors
Healthy Directions, LLC
KGK Science Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Change from Baseline in blood levels of Coenzyme Q10 at 28 days | 28 days |
Other
| 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 |
Countries
Canada
Outcome results
None listed