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

NCT02415114 | Completed Phase 1

• 1 other identifier: 15COHH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

CoQ10 Blood Levels; CoQ10 Blood Levels With Statin Use

Keywords

Coenzyme Q10; Resveratrol; Statin

Outcome Measures

Primary Outcomes (1)

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

  28 days

Secondary Outcomes (1)

• Change from Baseline in blood levels of Coenzyme Q10 at 28 days

  28 days

Other Outcomes (4)

• 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

Study Arms (2)

Healthy Population

ACTIVE COMPARATOR

Healthy Population with Omega Q Plus Resveratrol (with 50mg CoQ10)

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)

Dietary Supplement: Omega Q Plus Resveratrol (with 50mg CoQ10)

Interventions

Omega Q Plus Resveratrol (with 50mg CoQ10) DIETARY_SUPPLEMENT

Omega Q Plus Resveratrol (with 50mg CoQ10)

Healthy Population; Population taking Statins

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• KGK Science Inc.: lead
• Healthy Directions, LLC: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Interventions

Resveratrol; coenzyme Q10

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: April 14, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

CA (1)