Bioavailability of Coenzyme Q10NCT04780074

Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

A study testing Single dose intervention with Standard product (SP), Single dose intervention with Investigational product (IP1) and Single dose intervention with Investigational product (IP2) in people with Bioavailability of Coenzyme Q10, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The single-center, randomized, open-label, five-period crossover single-dose bioavailability study with five CoQ10 formulations Read more about this study

Who is it for?: Ages 18 to 65 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 Investigational product (IP1) and Single dose intervention with Investigational product (IP2)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSlovenia
Study dates: 28 Feb 2021to 13 Dec 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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject Informed consent form (ICF) is singed
Aged between 18 and 65 years at the time of the signature of ICF
A body mass index between 18.5-29.9 kg/m2
Total blood cholesterol range 3,11 - 6,50 mmol/L (not treated with medications)
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)

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
Pregnancy or planned pregnancy
Breast-feeding mother
Hypotension
Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or haematological disease, diabetes

Show all 13Show fewer

Gastrointestinal disorders or other serious acute or chronic diseases
Known lactose/gluten intolerances/ food allergies (limitation for standardisation of meals)
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

1 site in 1 country.

Slovenia1 site

ADM, ambulanta družinske medicine, Ljubljana, Slovenia
Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations in Healthy Adults

The single-center, randomized, open-label, five-period crossover single-dose bioavailability study with five CoQ10 formulations

Read the detailed description

The single-center, randomized, open-label, five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Study will be conducted with single dose CoQ10 to assess bioavailability.

Conditions: Bioavailability of Coenzyme Q10
Being tested: Single dose intervention with Standard product (SP), Single dose intervention with Investigational product (IP1), Single dose intervention with Investigational product (IP2), Single dose intervention with Investigational product (IP3), Single dose intervention with Investigational product (IP4)
Keywords: coenzyme q10, single 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
2 capsules - 200 mg total CoQ10
Single dose intervention with Investigational product (IP1)Dietary supplement
2 softgels - 200 mg total CoQ10
Single dose intervention with Investigational product (IP2)Dietary supplement
2 softgels - 200 mg total CoQ10
Single dose intervention with Investigational product (IP3)Dietary supplement
2 softgels - 200 mg total CoQ10
Single dose intervention with Investigational product (IP4)Dietary supplement
2 capsules - 200 mg total CoQ10

Study groups in NCT04780074
Study group	Role	What they receive
Standard product (SP): USP CoQ10 powder, hard capsules	Active comparator	100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10 Receives: Dietary Supplement: Single dose intervention with Standard product (SP)
Investigational product 1 (IP1): CoQ10 in soybean oil, softgels	Experimental	100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10 Receives: Dietary Supplement: Single dose intervention with Investigational product (IP1)
Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels	Experimental	100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10 Receives: Dietary Supplement: Single dose intervention with Investigational product (IP2)
Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels	Experimental	100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10 Receives: Dietary Supplement: Single dose intervention with Investigational product (IP3)
Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules	Experimental	100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10 Receives: Dietary Supplement: Single dose intervention with Investigational product (IP4)

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative single dose bioavailability (AUC48) of IP (in comparison to SP)
Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUC0-72h, i.e. area under the plasma concentration curve from the administration time to the last observation point (72h) of CoQ10 plasma concentrations above the baseline value.
Measured: 72 hours

Secondary outcomes (1)

Relative single dose bioavailability (AUCinf) of IP (in comparison to SP)
Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUCinf, i.e. extrapolated area under the CoQ10 plasma concentration curve above the baseline CoQ10 concentration.
Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 202113 Dec 2022

First posted3 Mar 2021
Study start28 Feb 2021
Primary completion21 May 2021
Study completion13 Dec 2022

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: Five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Subjects will test 5 formulations of single dose CoQ10 with 2 week wash-out. to assess bioavailability.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04780074
Sponsor's protocol ID: TISHCON/CoQ10-01
Status last verified: Dec 2022
First submitted: 23 Feb 2021
Last updated: 14 Dec 2022
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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations in Healthy Adults
ClinicalTrials.gov ID: NCT04780074
Acronym / sponsor ID: TISHCON/CoQ10-01
Conditions: Bioavailability of Coenzyme Q10
Keywords: coenzyme q10, single dose bioavailability
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Institute of Nutrition, Slovenia (Nutris)University, hospital or other
Collaborators: Vizera d.o.o., ADM, Ambulanta družinske medicine, Ljubljana, Slovenia, Adrialab d.o.o., Ljubljana, Slovenia, Tishcon Corp., USA
Study start: 28 Feb 2021 (actual)
Primary completion: 21 May 2021 (actual)
Study completion: 13 Dec 2022 (actual)
First posted: 3 Mar 2021 (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, five-period crossover single-dose bioavailability study with five CoQ10 formulations

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5
Model description: Five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Subjects will test 5 formulations of single dose CoQ10 with 2 week wash-out. to assess bioavailability.

Arm	Type	Receives
Standard product (SP): USP CoQ10 powder, hard capsules	Active comparator	Dietary Supplement: Single dose intervention with Standard product (SP)100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10
Investigational product 1 (IP1): CoQ10 in soybean oil, softgels	Experimental	Dietary Supplement: Single dose intervention with Investigational product (IP1)100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels	Experimental	Dietary Supplement: Single dose intervention with Investigational product (IP2)100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels	Experimental	Dietary Supplement: Single dose intervention with Investigational product (IP3)100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules	Experimental	Dietary Supplement: Single dose intervention with Investigational product (IP4)100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject Informed consent form (ICF) is singed
Aged between 18 and 65 years at the time of the signature of ICF
A body mass index between 18.5-29.9 kg/m2
Total blood cholesterol range 3,11 - 6,50 mmol/L (not treated with medications)
Healthy, meaning absence of any prescribed medication for a month prior to the inclusion to the study and during the study

Key exclusion criteria (13 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
Pregnancy or planned pregnancy
Breast-feeding mother
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
Single dose intervention with Standard product (SP)2 capsules - 200 mg total CoQ10	Dietary supplement	Standard product (SP): USP CoQ10 powder, hard capsules
Single dose intervention with Investigational product (IP1)2 softgels - 200 mg total CoQ10	Dietary supplement	Investigational product 1 (IP1): CoQ10 in soybean oil, softgels
Single dose intervention with Investigational product (IP2)2 softgels - 200 mg total CoQ10	Dietary supplement	Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels
Single dose intervention with Investigational product (IP3)2 softgels - 200 mg total CoQ10	Dietary supplement	Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels
Single dose intervention with Investigational product (IP4)2 capsules - 200 mg total CoQ10	Dietary supplement	Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules

Primary outcome

Relative single dose bioavailability (AUC48) of IP (in comparison to SP)
Time frame: 72 hours
Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUC0-72h, i.e. area under the plasma concentration curve from the administration time to the last observation point (72h) of CoQ10 plasma concentrations above the baseline value.

1 secondary outcome

Relative single dose bioavailability (AUCinf) of IP (in comparison to SP)
Time frame: 72 hours

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 14 Dec 2022.
Individual participant dataSharing planned: No

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

Tina Modrej Zadnikar principal investigator

ADM, Ambulanta družinske medicine, Ljubljana, Slovenia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 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 14 Dec 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?

Relative single dose bioavailability (AUC48) of IP (in comparison to SP) (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04780074.

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 14 Dec 2022.