ClinicalTrials.gg
CompletedNCT07530250Updated Aug 24, 2026

Assessing Two Coenzyme Q10 Products in Men and Women

An interventional study of high absorption CoQ10 product and standard CoQ10 product in CoQ10 Blood Levels, sponsored by Midwest Center for Metabolic and Cardiovascular Research. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Midwest Center for Metabolic and Cardiovascular Research · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • CoQ10 Blood Levels
03

In context

Lead sponsor

Midwest Center for Metabolic and Cardiovascular Research is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female, between 21 and 65 y of age.
  2. Individual has a of 18.5 to 34.9 kg/m2.
  3. Individual has a score ≥7 on the Vein Access Scale.
  4. Individual is willing to discontinue any dietary supplement use for two weeks prior to visit 2 and throughout the end of the testing period.
  5. Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening/baseline measurements.
  6. 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 to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. Individual has a history or presence of 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.
  3. Individual has had any major trauma or surgical event within 12 weeks prior to screening/baseline (visit 1).
  4. Individual has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
  5. Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening/baseline (visit 1).
  6. 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.
  7. 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.
  8. Individual has unstable use (defined as initiation or change in dose, agent, or regimen) of statin therapy within 3 months of visit 1.
  9. 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.
  10. Use of any prescription medication with known effects on appetite or weight (e.g., oral , weight loss medications, etc.) within 3 months of visit 1. A stable dose of selective serotonin reuptake inhibitors ≥3 months is allowed.
  11. Individual has lost ≥4.5 kg (10 lbs.) in the previous 3 months.
  12. 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.
  13. Individual follows a restricted diet (e.g., vegetarian, vegan, Atkins, etc.).
  14. Individual is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of and is unwilling to commit to the use of a medically approved form of throughout the study period.
  15. Individual has a known allergy or sensitivity to any ingredients in the study products or standardized meals/snacks.
  16. Individual has been exposed to any non-registered drug product within 30 days of the prior to screening/baseline (visit 1).
  17. 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).
  18. Individual has a condition the Investigator believes would interfere with his or her ability to provide , comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Experimental - high absorption CoQ10 product

    100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules)

    Dietary Supplement: high absorption CoQ10 product

  • Active comparator
    Active Comparator - standard CoQ10 product

    100 mg standard CoQ10 product (administered as two 50 mg capsules)

    Dietary Supplement: standard CoQ10 product

Interventions

  • Dietary supplementhigh absorption CoQ10 product

    100 mg CoQ10 product designed for high absorption (administered as two 50 mg capsules)

  • Dietary supplementstandard CoQ10 product

    100 mg standard CoQ10 product (administered as two 50 mg capsules)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 7 to 14 days between conditions

Secondary outcomes

  1. 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

    Time frame: 7 to 14 days between conditions

  2. 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

    Time frame: 7 to 14 days between conditions

  3. 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

    Time frame: 7 to 14 days between conditions

  4. 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

    Time frame: 7 to 14 days between conditions

  5. 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

    Time frame: 7 to 14 days between conditions

07

Study locations

1 site
  • Biofortis Clinical Research
    Addison, Illinois 60101, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2026 to primary completion in Jul 2026, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2026
First posted
Apr 15, 2026
StartActual
May 18, 2026
Primary completionActual
Jul 1, 2026
CompletionActual
Jul 1, 2026
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07530250
Lead sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
Pharmavite LLC
Responsible party
Sponsor
First posted
Apr 15, 2026
Start date
May 18, 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026
Last update
Aug 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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