Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

December 13, 2022 updated by: Igor Pravst, Nutrition Institute, Slovenia

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard product (SP): USP CoQ10 powder, hard capsules
100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10
Dietary supplement: Single dose intervention with Standard product (SP)
2 capsules - 200 mg total CoQ10
Experimental: Investigational product 1 (IP1): CoQ10 in soybean oil, softgels
100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Dietary supplement: Single dose intervention with Investigational product (IP1)
2 softgels - 200 mg total CoQ10
Experimental: Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels
100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Dietary supplement: Single dose intervention with Investigational product (IP2)
2 softgels - 200 mg total CoQ10
Experimental: Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels
100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Dietary supplement: Single dose intervention with Investigational product (IP3)
2 softgels - 200 mg total CoQ10
Experimental: Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules
100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10
Dietary supplement: Single dose intervention with Investigational product (IP4)
2 capsules - 200 mg total CoQ10

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative single dose bioavailability (AUCinf) 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 AUCinf, i.e. extrapolated area under the CoQ10 plasma concentration curve above the baseline CoQ10 concentration.
72 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative single dose bioavailability (AUC48) among all the investigational products
Time Frame: 72 hours
Relative bioavailability among all the investigational products (IP1 vs. IP2, IP1 vs. IP3, IP1 vs. IP4, IP2 vs. IP3, IP2 vs. IP4, and IP3 vs. IP4) 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.
72 hours
Relative single dose bioavailability (AUCinf) among all investigational products
Time Frame: 72 hours
Relative bioavailability among all investigational products (IP1 vs. IP2, IP1 vs. IP3, IP1 vs. IP4, IP2 vs. IP3, IP2 vs. IP4, and IP3 vs. IP4) expressed as ratio of baseline corrected AUCinf, i.e. extrapolated area under the CoQ10 plasma concentration curve above the baseline CoQ10 concentration.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutrition Institute, Slovenia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vizera d.o.o.
ADM, Ambulanta družinske medicine, Ljubljana, Slovenia
Adrialab d.o.o., Ljubljana, Slovenia
Tishcon Corp., USA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Igor Pravst, Nutrition Institute, Ljubljana
  • Principal Investigator: Tina Modrej Zadnikar, ADM, ambulanta družinske medicine, Ljubljana, Slovenia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TISHCON/CoQ10-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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