Coenzyme Q DeficiencyCo10_2024NCT06736366
Study With Two Coenzyme Q10 Products
A study testing Dietary supplement - Active comparator and Dietary supplement - Experimental product in people with Coenzyme Q Deficiency, run by University of Primorska at 1 site in Slovenia.
Trial summary
The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coenzyme Q Deficiency
- What is being tested?
- Dietary supplement - Active comparator and Dietary supplement - Experimental product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 Dec 2024to 30 Jun 2025
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subject informed consent form
- aged between 50 and 65 years old
- body mass for women 70± 5 kg and for men 85± 5 kg
- non-smoking
- healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases
- absence of any prescribed medication during the study
- willing to avoid a consumption of any food supplements at least 2 weeks before and during the study
Who cannot join
- cardio-vascular diseases, diabetes, neurodegenerative diseases, gastrointestinal disorders, pregnancy, breast-feeding
- intake of any food supplements within two week of the beginning of the study
- drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska, Faculty of Health Sciences
Izola, Municipality of Izola, 6310
About this study
Official title: Comparative Single-dose Bioavailability Clinical Study of Two Different Coenzyme Q10 Products
The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products
Read the detailed description
The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products will include 35 subjects who will test two different coenzyme Q10 products. Plasma concentration of coenzyme Q10 will be measured.
- Conditions
- Coenzyme Q Deficiency
- Being tested
- Dietary supplement - Active comparator, Dietary supplement - Experimental product
- Keywords
- single dose bioavailability, Coenzyme Q10
- Medical subject headings
- Coenzyme Q10 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement - Active comparatorDietary supplement
Single dose intervention with Standard product Coenzyme Q10 (ubiquinone); 2 capsules - 100 mg total coenzyme Q10
Dietary supplement - Experimental productDietary supplement
Single dose intervention with Experimental product; BMT® coenzyme Q10; 2 capsules - 100 mg total coenzyme Q10
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 (ubiquinone) | Active comparator | Synonyms: Maltodextrin, capsule (HPMC - hydroxypropyl methyl cellulose), coenzyme Q10 (ubiquinone); Dosage: 2 capsules, total 100 mg Co-Q10 Receives: Dietary Supplement: Dietary supplement - Experimental product |
| BMT® coenzyme Q10 | Experimental | Maltodextrin, BMT® coenzyme Q10 [maltodextrin, coenzyme Q10 (ubiquinone), stabiliser (gum arabic), corn starch, olive oil, anti-caking agent (silicon dioxide), acidity regulators (acetic acid, citric acid)], capsule (HPMC - hydroxypropyl methyl cellulose); Dosage: 2 capsules, total 100 mg Co-Q10 Receives: Dietary Supplement: Dietary supplement - Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of Coenzyme Q10
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Measured: At Baseline
Plasma levels of Coenzyme Q10
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Measured: Four hours after consumption
Plasma levels of Coenzyme Q10
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Measured: Six hours after consumption
Plasma levels of Coenzyme Q10
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Measured: Twelve hours after consumption
Plasma levels of Coenzyme Q10
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Measured: Twenty-four hours after consumption
Plasma levels of Coenzyme Q10
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Measured: Forthy-eight hours after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start5 Dec 2024
- Primary completion16 Dec 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coenzyme Q DeficiencyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- Biostile, QFarm s.r.l.
- Responsible party
- Principal investigator, Zala Jenko Praznikar, University of Primorska
- Investigators
- Ana Petelin, phD, Principal investigator, University of Primorska, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736366
- Sponsor's protocol ID
- Q10_2024
- Acronym
- Co10_2024
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Single-dose Bioavailability Clinical Study of Two Different Coenzyme Q10 Products
- ClinicalTrials.gov ID
- NCT06736366
- Acronym / sponsor ID
- Co10_2024 / Q10_2024
- Conditions
- Coenzyme Q Deficiency
- Keywords
- single dose bioavailability, Coenzyme Q10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- Biostile, QFarm s.r.l.
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Dec 2024 (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 randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products
Detailed description
The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products will include 35 subjects who will test two different coenzyme Q10 products. Plasma concentration of coenzyme Q10 will be measured.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 (ubiquinone) | Active comparator | Dietary Supplement: Dietary supplement - Experimental productSynonyms: Maltodextrin, capsule (HPMC - hydroxypropyl methyl cellulose), coenzyme Q10 (ubiquinone); Dosage: 2 capsules, total 100 mg Co-Q10 |
| BMT® coenzyme Q10 | Experimental | Dietary Supplement: Dietary supplement - Active comparatorMaltodextrin, BMT® coenzyme Q10 [maltodextrin, coenzyme Q10 (ubiquinone), stabiliser (gum arabic), corn starch, olive oil, anti-caking agent (silicon dioxide), acidity regulators (acetic acid, citric acid)], capsule (HPMC - hydroxypropyl methyl cellulose); Dosage: 2 capsules, total 100 mg Co-Q10 |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- subject informed consent form
- aged between 50 and 65 years old
- body mass for women 70± 5 kg and for men 85± 5 kg
- non-smoking
- healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases
Key exclusion criteria (3 listed)
- cardio-vascular diseases, diabetes, neurodegenerative diseases, gastrointestinal disorders, pregnancy, breast-feeding
- intake of any food supplements within two week of the beginning of the study
- drug or alcohol abuse
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 |
|---|---|---|
| Dietary supplement - Active comparatorSingle dose intervention with Standard product Coenzyme Q10 (ubiquinone); 2 capsules - 100 mg total coenzyme Q10 | Dietary supplement | BMT® coenzyme Q10 |
| Dietary supplement - Experimental productSingle dose intervention with Experimental product; BMT® coenzyme Q10; 2 capsules - 100 mg total coenzyme Q10 | Dietary supplement | Coenzyme Q10 (ubiquinone) |
Primary outcome
Plasma levels of Coenzyme Q10
Time frame: At Baseline
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Plasma levels of Coenzyme Q10
Time frame: Four hours after consumption
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Plasma levels of Coenzyme Q10
Time frame: Six hours after consumption
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Plasma levels of Coenzyme Q10
Time frame: Twelve hours after consumption
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Plasma levels of Coenzyme Q10
Time frame: Twenty-four hours after consumption
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
Plasma levels of Coenzyme Q10
Time frame: Forthy-eight hours after consumption
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
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 5 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Ana Petelin, phD principal investigator
University of Primorska, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement - Active comparator and Dietary supplement - Experimental product in people with Coenzyme Q Deficiency, run by University of Primorska at 1 site in Slovenia.
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 7 inclusion and 3 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 5 Dec 2025. 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 Slovenia. 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?
Plasma levels of Coenzyme Q10 (time frame: At Baseline). The study lists 6 primary outcomes in all. 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 5 Dec 2025.