Assessing Two Coenzyme Q10 Products in Men and Women

Official title

A Randomized, Double-blind, Crossover Study to Assess the Relative Bioavailability of Two Coenzyme Q10 Products in Men and Women

Overview

The goal of this clinical trial is to compare the relative bioavailability of coenzyme Q10 (CoQ10) from acute administrations of a CoQ10 product designed for enhanced absorption versus a standard CoQ10 product in healthy men and women. Participants will be asked to come to the clinical on five different occasions, including a screening visit (visit 1, -7 days), two test 1 visits (visits 2 and 3, days 0 and 1), and two test 2 visits (visits 4 and 5, days 7 and 8). During the start of each test visit (visits 2 and 4), the participant will consume each study product with water and a standardized breakfast meal. Then, blood samples will be collected over a 10-hour period, and a standardized lunch, dinner, and snacks will be provided. The participant will return to the clinic the next morning for a blood draw 24 hours after the study product ingestion from the previous day. The same procedures will be repeated 7 to 14 days later with the other study product.

Detailed description

The study products will include 100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules) and 100 mg standard CoQ10 product (administered as two 50 mg capsules).

Interventions

• Dietary supplement high absorption CoQ10 product
  100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules)
• Dietary supplement standard CoQ10 product
  100 mg standard CoQ10 product (administered as two 50 mg capsules)

Primary outcome measures

• Net incremental area under the curve (niAUC) for plasma CoQ10 [Time frame: 7 to 14 days between conditions]

Secondary outcome measures (5)

• Incremental area under the curve (iAUC) for plasma CoQ10 [Time frame: 7 to 14 days between conditions]
• Total area under the curve (AUC) for plasma CoQ10 [Time frame: 7 to 14 days between conditions]
• Unadjusted maximum concentration (Cmax) for plasma CoQ10 [Time frame: 7 to 14 days between conditions]
• Baseline-adjusted maximum concentration (Cmax) for plasma CoQ10 [Time frame: 7 to 14 days between conditions]
• Time to maximum concentration (Tmax) for plasma CoQ10 [Time frame: 7 to 14 days between conditions]

Eligibility criteria

Inclusion criteria

• Male or female, between 21 and 65 y of age.
• Individual has a BMI of 18.5 to 34.9 kg/m2.
• Individual has a score ≥7 on the Vein Access Scale.
• Individual is willing to discontinue any dietary supplement use for two weeks prior to visit 2 and throughout the end of the testing period.
• Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening/baseline measurements.
• Individual understands the study procedures, including maintaining usual physical activity pattern and refraining from vigorous physical activity for 24 h prior to each clinic visit requiring a blood draw. Signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion criteria

• Individual has any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
• Individual has a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, or stroke), pulmonary, renal, hepatic, or biliary disorders.
• Individual has had any major trauma or surgical event within 12 weeks prior to screening/baseline (visit 1).
• Individual has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
• Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening/baseline (visit 1).
• Individual has a laboratory test result of clinical significance at screening/baseline (visit 1) based on the judgment of the Principal Investigator or qualified designee.
• Individual has signs or symptoms of an active infection of clinical significance (e.g., urinary tract or respiratory) within five days prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have been resolved for at least five days and, if antibiotics were prescribed, antibiotic therapy has been completed at least 7 days prior to the test visit.
• Individual has unstable use (defined as initiation or change in dose, agent, or regimen) of statin therapy within 3 months of visit 1.
• Individual uses medications or dietary supplements known to interfere with CoQ10 metabolism within 14 days prior to screening/baseline (visit 1) and throughout the study period, including, but not limited to, lipid-lowering (stable dose of statin therapy is allowed), anti-hypertensive, hypoglycemic, anti-coagulant, and psychotherapeutic therapies. For all other medications, individual must be on a stable dose for at least 3 months prior to visit 1.
• Use of any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications, etc.) within 3 months of visit 1. A stable dose of selective serotonin reuptake inhibitors ≥3 months is allowed.
• Individual has lost ≥4.5 kg (10 lbs.) in the previous 3 months.
• Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 6 months of visit 1. Occasional use (defined as less than once per week) within 6 months of visit 1 is allowed but requires that the participant refrain for 24 hours prior to and during test visits.
• Individual follows a restricted diet (e.g., vegetarian, vegan, Atkins, etc.).
• Individual is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
• Individual has a known allergy or sensitivity to any ingredients in the study products or standardized meals/snacks.
• Individual has been exposed to any non-registered drug product within 30 days of the prior to screening/baseline (visit 1).
• Individual has a current or recent history (past 12 months of screening/baseline) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
• Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Quadruple blind

Primary purpose

Other

Study locations

United States · 1 center

• Biofortis Clinical Research — Addison

Identifiers

NCT: NCT07530250 · MB-2580

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗