Bioavailability of Coenzyme Q10CoQ10-01NCT03284814
Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults
A study testing Single dose intervention with Standard product (SP), Single dose intervention with Comparative product (CP) and Single dose intervention with Investigational product (IP) in people with Bioavailability of Coenzyme Q10, run by Institute of Nutrition, Slovenia (Nutris) at 3 sites in Slovenia.
Trial summary
The single-center, randomized, open-label, three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous… Read more about this study
- Who is it for?
- Ages 65 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability of Coenzyme Q10
- What is being tested?
- Single dose intervention with Standard product (SP), Single dose intervention with Comparative product (CP) and Single dose intervention with Investigational product (IP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesSlovenia
- Study dates
- 29 Aug 2017to 20 Oct 2017
- 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 65 to 74 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subject Informed consent form (ICF) is singed
- Aged between 65 and 74 years at the time of the signature of ICF
- A body mass index between 20 and 29 kg/m2
- Healthy, meaning absence of any prescribed medication for a month prior to the inclusion to the study and during the study
- Willing to avoid a consumption of any food supplements except vitamin D and calcium at least 2 weeks before and during the study
- Consumption of dairy and cereal products (standardised breakfast will include low lactose dairy and bread)
- Willing to follow all study procedures, including attending all site visits (including sessions during which a venous line will be inserted for blood sampling), and keeping a diary for the time of multiple-dose study (to follow their compliance and palatability)
Who cannot join
- Intake of any prescribed medication within 2 weeks of the beginning of the study
- Intake of any food supplements within 2 weeks of the beginning of the study, except vitamin D and calcium
- Hypotension
- Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or hematological disease, diabetes
- Gastrointestinal disorders or other serious acute or chronic diseases
- Known lactose/gluten intolerances/ food allergies (limitation for standardisation of meals)
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- Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
- Known drug and/or alcohol abuse
- Using any form of nicotine or tobacco
- Mental incapacity that precludes adequate understanding or cooperation
- Participation in another investigational study or blood donation within 3 months prior to or during this study
Trial locations and contacts
3 sites in 1 country.
Slovenia3 sites
MEDEDUS, Ljubljana, Slovenia
Ljubljana, 1000
Nutrition Institute, Ljubljana
Ljubljana, 1000
Vizera d.o.o., Ljubljana, Slovenia
Ljubljana, 1000
About this study
Official title: Single-dose and Multiple-dose Comparative Bioavailability Study of Three CoQ10 Formulations in Healthy Elderly Adults
The single-center, randomized, open-label, three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.
- Conditions
- Bioavailability of Coenzyme Q10
- Being tested
- Single dose intervention with Standard product (SP), Single dose intervention with Comparative product (CP), Single dose intervention with Investigational product (IP), Multiple dose intervention with Standard product (SP), Multiple dose intervention with Comparative product (CP)
- Keywords
- coenzyme q10, single dose bioavailability, multiple dose bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose intervention with Standard product (SP)Dietary supplement
hard capsules, 100 mg
Single dose intervention with Comparative product (CP)Dietary supplement
soft-gel capsules, 100 mg
Single dose intervention with Investigational product (IP)Dietary supplement
syrup, 100 mg
Multiple dose intervention with Standard product (SP)Dietary supplement
hard capsules, 100 mg - 14 days
Multiple dose intervention with Comparative product (CP)Dietary supplement
soft-gel capsules, 100 mg - 14 days
Multiple dose intervention with Investigational product (IP)Dietary supplement
syrup, 100 mg - 14 days
| Study group | Role | What they receive |
|---|---|---|
| Standard product group | Active comparator | This group will be included in a single dose cross over study, and in multiple dose study with standard product (SP: CoQ10 hard capsules; 100 mg) Receives: Dietary Supplement: Single dose intervention with Standard product (SP); Dietary Supplement: Single dose intervention with Comparative product (CP); Dietary Supplement: Single dose intervention with Investigational product (IP); Dietary Supplement: Multiple dose intervention with Standard product (SP) |
| Comparative product group | Active comparator | This group will be included in a single dose cross over study, and in multiple dose study with comparative product (CP: CoQ10 soft-gel capsules; 100 mg) Receives: Dietary Supplement: Single dose intervention with Standard product (SP); Dietary Supplement: Single dose intervention with Comparative product (CP); Dietary Supplement: Single dose intervention with Investigational product (IP); Dietary Supplement: Multiple dose intervention with Comparative product (CP) |
| Investigational product group | Experimental | This group will be included in a single dose cross over study, and in multiple dose study with investigational product (IP: CoQ10 syrup; 100 mg) Receives: Dietary Supplement: Single dose intervention with Standard product (SP); Dietary Supplement: Single dose intervention with Comparative product (CP); Dietary Supplement: Multiple dose intervention with Investigational product (IP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved single dose bioavailability of IP (in comparison to SP)
Relative bioavailability between the investigational and standard product expressed as ratio of AUC0-48h (area under the plasma concentration curve from the administration time to the last observation point, i.e. 48h) of total CoQ10 plasma concentrations above the baseline value.
Measured: 48 hours
improved plasma CoQ10 level after multiple dose study for IP (in comparison to SP)
Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational and standard product.
Measured: 14 days
Secondary outcomes (2)
comparable single dose bioavailability of IP (in comparison to CP)
Relative bioavailability between the investigational product and comparator expressed as ratio of AUC0-48h of total CoQ10 plasma concentrations above the baseline value.
Measured: 48 hours
comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP)
Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational product and comparator.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start29 Aug 2017
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of Coenzyme Q10Studies 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
- Model description
- Three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- Vizera d.o.o., Valens Int. d.o.o., Slovenija, MEDEDUS, Ljubljana, Slovenia
- Responsible party
- Principal investigator, Snežana Kocijančič, Institute of Nutrition, Slovenia (Nutris)
- Investigators
- Igor Pravst, Principal investigator, Nutrition Institute, LjubljanaSnežana Kocijančič, Principal investigator, MEDEDUS, Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284814
- Sponsor's protocol ID
- KME 89/07/17
- Acronym
- CoQ10-01
- Status last verified
- Mar 2019
- First submitted
- 13 Sep 2017
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose and Multiple-dose Comparative Bioavailability Study of Three CoQ10 Formulations in Healthy Elderly Adults
- ClinicalTrials.gov ID
- NCT03284814
- Acronym / sponsor ID
- CoQ10-01 / KME 89/07/17
- Conditions
- Bioavailability of Coenzyme Q10
- Keywords
- coenzyme q10, single dose bioavailability, multiple dose bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)University, hospital or other
- Collaborators
- Vizera d.o.o., Valens Int. d.o.o., Slovenija, MEDEDUS, Ljubljana, Slovenia
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 15 Sep 2017 (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 single-center, randomized, open-label, three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.
| Arm | Type | Receives |
|---|---|---|
| Standard product group | Active comparator | Dietary Supplement: Single dose intervention with Standard product (SP), Dietary Supplement: Single dose intervention with Comparative product (CP), Dietary Supplement: Single dose intervention with Investigational product (IP), Dietary Supplement: Multiple dose intervention with Standard product (SP)This group will be included in a single dose cross over study, and in multiple dose study with standard product (SP: CoQ10 hard capsules; 100 mg) |
| Comparative product group | Active comparator | Dietary Supplement: Single dose intervention with Standard product (SP), Dietary Supplement: Single dose intervention with Comparative product (CP), Dietary Supplement: Single dose intervention with Investigational product (IP), Dietary Supplement: Multiple dose intervention with Comparative product (CP)This group will be included in a single dose cross over study, and in multiple dose study with comparative product (CP: CoQ10 soft-gel capsules; 100 mg) |
| Investigational product group | Experimental | Dietary Supplement: Single dose intervention with Standard product (SP), Dietary Supplement: Single dose intervention with Comparative product (CP), Dietary Supplement: Multiple dose intervention with Investigational product (IP)This group will be included in a single dose cross over study, and in multiple dose study with investigational product (IP: CoQ10 syrup; 100 mg) |
Who may qualify
- Ages
- 65 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Subject Informed consent form (ICF) is singed
- Aged between 65 and 74 years at the time of the signature of ICF
- A body mass index between 20 and 29 kg/m2
- Healthy, meaning absence of any prescribed medication for a month prior to the inclusion to the study and during the study
- Willing to avoid a consumption of any food supplements except vitamin D and calcium at least 2 weeks before and during the study
Key exclusion criteria (11 listed)
- Intake of any prescribed medication within 2 weeks of the beginning of the study
- Intake of any food supplements within 2 weeks of the beginning of the study, except vitamin D and calcium
- Hypotension
- Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or hematological disease, diabetes
- Gastrointestinal disorders or other serious acute or chronic diseases
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 |
|---|---|---|
| Single dose intervention with Standard product (SP)hard capsules, 100 mg | Dietary supplement | Comparative product group, Investigational product group, Standard product group |
| Single dose intervention with Comparative product (CP)soft-gel capsules, 100 mg | Dietary supplement | Comparative product group, Investigational product group, Standard product group |
| Single dose intervention with Investigational product (IP)syrup, 100 mg | Dietary supplement | Comparative product group, Standard product group |
| Multiple dose intervention with Standard product (SP)hard capsules, 100 mg - 14 days | Dietary supplement | Standard product group |
| Multiple dose intervention with Comparative product (CP)soft-gel capsules, 100 mg - 14 days | Dietary supplement | Comparative product group |
| Multiple dose intervention with Investigational product (IP)syrup, 100 mg - 14 days | Dietary supplement | Investigational product group |
Primary outcome
improved single dose bioavailability of IP (in comparison to SP)
Time frame: 48 hours
Relative bioavailability between the investigational and standard product expressed as ratio of AUC0-48h (area under the plasma concentration curve from the administration time to the last observation point, i.e. 48h) of total CoQ10 plasma concentrations above the baseline value.
improved plasma CoQ10 level after multiple dose study for IP (in comparison to SP)
Time frame: 14 days
Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational and standard product.
2 secondary outcomes
comparable single dose bioavailability of IP (in comparison to CP)
Time frame: 48 hours
comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP)
Time frame: 14 days
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 20 Mar 2019.
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.
Igor Pravst principal investigator
Nutrition Institute, Ljubljana
Snežana Kocijančič principal investigator
MEDEDUS, Ljubljana, Slovenia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single dose intervention with Standard product (SP), Single dose intervention with Comparative product (CP) and Single dose intervention with Investigational product (IP) in people with Bioavailability of Coenzyme Q10, run by Institute of Nutrition, Slovenia (Nutris) at 3 sites 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 11 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 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
improved single dose bioavailability of IP (in comparison to SP) (time frame: 48 hours). The study lists 2 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 20 Mar 2019.