Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults (CoQ10-01)

March 18, 2019 updated by: Snežana Kocijančič, Nutrition Institute, Slovenia

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.

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.

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.
21

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
        • Nutrition Institute, Ljubljana
      • Ljubljana, Slovenia, 1000
        • MEDEDUS, Ljubljana, Slovenia
      • Ljubljana, Slovenia, 1000
        • Vizera d.o.o., 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

61 years to 70 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

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
  • 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)
  • 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 group
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)
Dietary supplement: Single dose intervention with Standard product (SP)
hard capsules, 100 mg
Dietary supplement: Single dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg
Dietary supplement: Single dose intervention with Investigational product (IP)
syrup, 100 mg
Dietary supplement: Multiple dose intervention with Standard product (SP)
hard capsules, 100 mg - 14 days
Active Comparator: Comparative product group
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)
Dietary supplement: Single dose intervention with Standard product (SP)
hard capsules, 100 mg
Dietary supplement: Single dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg
Dietary supplement: Single dose intervention with Investigational product (IP)
syrup, 100 mg
Dietary supplement: Multiple dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg - 14 days
Experimental: Investigational product group
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)
Dietary supplement: Single dose intervention with Standard product (SP)
hard capsules, 100 mg
Dietary supplement: Single dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg
Dietary supplement: Multiple dose intervention with Investigational product (IP)
syrup, 100 mg - 14 days

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
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.
48 hours
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.
14 days

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
comparable single dose bioavailability of IP (in comparison to CP)
Time Frame: 48 hours
Relative bioavailability between the investigational product and comparator expressed as ratio of AUC0-48h of total CoQ10 plasma concentrations above the baseline value.
48 hours
comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP)
Time Frame: 14 days
Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational product and comparator.
14 days

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.
MEDEDUS, Ljubljana, Slovenia
Vizera d.o.o.
Valens Int. d.o.o., Slovenija

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: Snežana Kocijančič, MEDEDUS, 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.
August 29, 2017

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.
October 20, 2017

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.
October 20, 2017

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).
September 13, 2017

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.
September 13, 2017

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.
September 15, 2017

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.
March 20, 2019

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.
March 18, 2019

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.
March 1, 2019

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.
  • KME 89/07/17

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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