CoQ10 Blood LevelsNCT07530250
Assessing Two Coenzyme Q10 Products in Men and Women
A study testing high absorption CoQ10 product and standard CoQ10 product in people with CoQ10 Blood Levels, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- CoQ10 Blood Levels
- What is being tested?
- high absorption CoQ10 product and standard CoQ10 product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
Official title: A Randomized, Double-blind, Crossover Study to Assess the Relative Bioavailability of Two Coenzyme Q10 Products in Men and Women
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.
Read the 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).
- Conditions
- CoQ10 Blood Levels
- Being tested
- high absorption CoQ10 product, standard CoQ10 product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high absorption CoQ10 productDietary supplement
100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules)
standard CoQ10 productDietary supplement
100 mg standard CoQ10 product (administered as two 50 mg capsules)
| Study group | Role | What they receive |
|---|---|---|
| Experimental - high absorption CoQ10 product | Experimental | 100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules) Receives: Dietary Supplement: high absorption CoQ10 product |
| Active Comparator - standard CoQ10 product | Active comparator | 100 mg standard CoQ10 product (administered as two 50 mg capsules) Receives: Dietary Supplement: standard CoQ10 product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net incremental area under the curve (niAUC) for plasma CoQ10
Difference between conditions in the niAUC for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion
Measured: 7 to 14 days between conditions
Secondary outcomes (5)
Incremental area under the curve (iAUC) for plasma CoQ10
Difference between conditions in the iAUC for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion
Measured: 7 to 14 days between conditions
Total area under the curve (AUC) for plasma CoQ10
Difference between conditions in the total AUC for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion
Measured: 7 to 14 days between conditions
Unadjusted maximum concentration (Cmax) for plasma CoQ10
Difference between conditions in the unadjusted Cmax for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion
Measured: 7 to 14 days between conditions
Baseline-adjusted maximum concentration (Cmax) for plasma CoQ10
Difference between conditions in the baseline-adjusted Cmax for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion
Measured: 7 to 14 days between conditions
Time to maximum concentration (Tmax) for plasma CoQ10
Difference between conditions in the Tmax for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion
Measured: 7 to 14 days between conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start18 May 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoQ10 Blood LevelsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmavite LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530250
- Sponsor's protocol ID
- MB-2580
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Crossover Study to Assess the Relative Bioavailability of Two Coenzyme Q10 Products in Men and Women
- ClinicalTrials.gov ID
- NCT07530250
- Acronym / sponsor ID
- MB-2580
- Conditions
- CoQ10 Blood Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Pharmavite LLC
- Study start
- 18 May 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - high absorption CoQ10 product | Experimental | Dietary Supplement: high absorption CoQ10 product100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules) |
| Active Comparator - standard CoQ10 product | Active comparator | Dietary Supplement: standard CoQ10 product100 mg standard CoQ10 product (administered as two 50 mg capsules) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high absorption CoQ10 product100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules) | Dietary supplement | Experimental - high absorption CoQ10 product |
| standard CoQ10 product100 mg standard CoQ10 product (administered as two 50 mg capsules) | Dietary supplement | Active Comparator - standard CoQ10 product |
Primary outcome
Net incremental area under the curve (niAUC) for plasma CoQ10
Time frame: 7 to 14 days between conditions
Difference between conditions in the niAUC for plasma CoQ10 from 0 to 24 h where t = 0 is the time of study product ingestion
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high absorption CoQ10 product and standard CoQ10 product in people with CoQ10 Blood Levels, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net incremental area under the curve (niAUC) for plasma CoQ10 (time frame: 7 to 14 days between conditions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.