Coenzyme Q DeficiencyNCT05272228
Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
A study testing Dietary supplement - standard product, Dietary supplement - Investigational product IP1 and Dietary supplement - Investigational product IP2 in people with Coenzyme Q Deficiency, run by University of Primorska at 1 site in Slovenia.
Trial summary
The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Coenzyme Q Deficiency
- What is being tested?
- Dietary supplement - standard product, Dietary supplement - Investigational product IP1 and Dietary supplement - Investigational product IP2
- 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
- 9 Mar 2022to 15 Jul 2022
- 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- subject informed consent form
- aged between 40 and 55 years old
- body mass for women 65± 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
- willing to study all study procedures
Who cannot join
- cardio-vascular diseases,
- diabetes,
- neurodegenerative diseases,
- gastrointestinal disorders
- hypotension
- pregnancy
Show all 10Show fewer
- breast-feeding
- intake of any prescribed medication within two week of the beginning of the study
- 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.
About this study
Official title: The Single-centre, Randomized, Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products
Read the detailed description
The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products will include 25 subjects who will test three different coenzyme Q10 products. Serum concentration of coenzyme Q10 will be measured.
- Conditions
- Coenzyme Q Deficiency
- Being tested
- Dietary supplement - standard product, Dietary supplement - Investigational product IP1, Dietary supplement - Investigational product IP2
- Keywords
- coenzyme Q10, single dose bioavailability
- 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 - standard productDietary supplement
Single dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10
Dietary supplement - Investigational product IP1Dietary supplement
Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10
Dietary supplement - Investigational product IP2Dietary supplement
Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 (ubiquinone) | Active comparator | Synonyms: Co-Q10; Ubiquinone; Ubidecarenone; 2,5-Cyclohexadiene-1,4-dione, 2- [(2E,6E,10E,14E,18E,22E,26E,30E,34E)-3,7,11,15,19,23,27,31,35,39-decamethyl-,6,10,14,18,22,26,30,34,38- tetracontadecaenyl]-5,6-dimethoxy-3-methyl CAS number: 303-98-0 Molecular formula: C59H90O4 USP standard Content: Co-Q10 (ubiquinone), bulking agent (maltodextrin), capsule (HPCM- hydroxypropyl methyl cellulose), anti-adherents (magnesium stearate and anhydrous silica) Dosage: 2 capsules, total 100 mg Co-Q10 Receives: Dietary Supplement: Dietary supplement - standard product |
| Q10 MICROENCAPSULATED | Experimental | IP1:Q10 MICROENCAPSULATED. ENG: Ingredient BMT® Coenzyme Q10 Content Co-Q10 (ubiquinone), stabiliser (gum arabic), bulking agent (maltodextrin), capsule (HPCM- hydroxypropyl methyl cellulose), olive oil, corn starch, anti-adherents (magnesium stearate and anhydrous silica), acidity regulator (citric acid, acetic acid) HPMC capsules, size '0', 50 mg/capsule Dosage: 2 capsule, total 100 mg Co-Q10 Receives: Dietary Supplement: Dietary supplement - Investigational product IP1 |
| Final formulated product BQSM® | Experimental | IP2: Final formulated product BQSM® Ingredients: Rosehip (Rosa canina) fruit extract standardised to min. 70 % of vitamin C (L-ascorbic acid), capsule (HPCM- hydroxypropyl methyl cellulose), BMT® Coenzyme Q10 (ubiquinone), vitamin E (D-alfa tocopheryl acetate), vitamin A (retinyl acetate), L-selenomethionine, bulking agent (maltodextrin), stabiliser (gum arabic), olive oil, corn starch, anti-adherents (magnesium stearate and anhydrous silica), acidity regulator (citric acid, acetic acid) HPMC capsule, size '0', 50 mg/capsule Dosage: 2 capsule, total 100 mg Co-Q10 Receives: Dietary Supplement: Dietary supplement - Investigational product IP2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum coenzyme Q10 concentrations
Serum coenzyme Q10 concentrations will me measured in all three different coenzyme Q10 products with ELISA kit for coenzyme Q10
Measured: 0,2,4,6,8,12 and 24 hours after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start9 Mar 2022
- Primary completion15 May 2022
- Study completion15 Jul 2022
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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- Biovis d.o.o.
- Responsible party
- Principal investigator, Zala Jenko Praznikar, University of Primorska
- Investigators
- Zala Jenko-Pražnikar, PhD, Principal investigator, University of Primorska, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272228
- Sponsor's protocol ID
- CoenzymeQ10
- Status last verified
- Jul 2022
- First submitted
- 28 Feb 2022
- Last updated
- 21 Jul 2022
- Results posted
- 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 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Single-centre, Randomized, Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
- ClinicalTrials.gov ID
- NCT05272228
- Acronym / sponsor ID
- CoenzymeQ10
- Conditions
- Coenzyme Q Deficiency
- Keywords
- coenzyme Q10, single dose bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- Biovis d.o.o.
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 9 Mar 2022 (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, three period crossover single-dose bioavailability study with three coenzyme Q10 products
Detailed description
The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products will include 25 subjects who will test three different coenzyme Q10 products. Serum concentration of coenzyme Q10 will be measured.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 (ubiquinone) | Active comparator | Dietary Supplement: Dietary supplement - standard productSynonyms: Co-Q10; Ubiquinone; Ubidecarenone; 2,5-Cyclohexadiene-1,4-dione, 2- [(2E,6E,10E,14E,18E,22E,26E,30E,34E)-3,7,11,15,19,23,27,31,35,39-decamethyl-,6,10,14,18,22,26,30,34,38- tetracontadecaenyl]-5,6-dimethoxy-3-methyl CAS number: 303-98-0 Molecular formula: C59H90O4 USP standard Content: Co-Q10 (ubiquinone), bulking agent (maltodextrin), capsule (HPCM- hydroxypropyl methyl cellulose), anti-adherents (magnesium stearate and anhydrous silica) Dosage: 2 capsules, total 100 mg Co-Q10 |
| Q10 MICROENCAPSULATED | Experimental | Dietary Supplement: Dietary supplement - Investigational product IP1IP1:Q10 MICROENCAPSULATED. ENG: Ingredient BMT® Coenzyme Q10 Content Co-Q10 (ubiquinone), stabiliser (gum arabic), bulking agent (maltodextrin), capsule (HPCM- hydroxypropyl methyl cellulose), olive oil, corn starch, anti-adherents (magnesium stearate and anhydrous silica), acidity regulator (citric acid, acetic acid) HPMC capsules, size '0', 50 mg/capsule Dosage: 2 capsule, total 100 mg Co-Q10 |
| Final formulated product BQSM® | Experimental | Dietary Supplement: Dietary supplement - Investigational product IP2IP2: Final formulated product BQSM® Ingredients: Rosehip (Rosa canina) fruit extract standardised to min. 70 % of vitamin C (L-ascorbic acid), capsule (HPCM- hydroxypropyl methyl cellulose), BMT® Coenzyme Q10 (ubiquinone), vitamin E (D-alfa tocopheryl acetate), vitamin A (retinyl acetate), L-selenomethionine, bulking agent (maltodextrin), stabiliser (gum arabic), olive oil, corn starch, anti-adherents (magnesium stearate and anhydrous silica), acidity regulator (citric acid, acetic acid) HPMC capsule, size '0', 50 mg/capsule Dosage: 2 capsule, total 100 mg Co-Q10 |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- subject informed consent form
- aged between 40 and 55 years old
- body mass for women 65± 5 kg and for men 85± 5 kg
- non-smoking
- healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases
Key exclusion criteria (10 listed)
- cardio-vascular diseases,
- diabetes,
- neurodegenerative diseases,
- gastrointestinal disorders
- hypotension
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 - standard productSingle dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10 | Dietary supplement | Coenzyme Q10 (ubiquinone) |
| Dietary supplement - Investigational product IP1Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10 | Dietary supplement | Q10 MICROENCAPSULATED |
| Dietary supplement - Investigational product IP2Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10 | Dietary supplement | Final formulated product BQSM® |
Primary outcome
Serum coenzyme Q10 concentrations
Time frame: 0,2,4,6,8,12 and 24 hours after ingestion
Serum coenzyme Q10 concentrations will me measured in all three different coenzyme Q10 products with ELISA kit for coenzyme Q10
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 21 Jul 2022.
- 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.
Zala Jenko-Pražnikar, 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 - standard product, Dietary supplement - Investigational product IP1 and Dietary supplement - Investigational product IP2 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 8 inclusion and 10 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 21 Jul 2022. 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?
Serum coenzyme Q10 concentrations (time frame: 0,2,4,6,8,12 and 24 hours after ingestion). 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 21 Jul 2022.