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NCT04780074

Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

NCT ID: NCT04780074

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2022-12-13

Brief Summary

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

Detailed Description

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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

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Bioavailability of Coenzyme Q10

Keywords

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coenzyme q10 single dose bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standard product (SP): USP CoQ10 powder, hard capsules

100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10

Group Type ACTIVE_COMPARATOR

Single dose intervention with Standard product (SP)

Intervention Type DIETARY_SUPPLEMENT

2 capsules - 200 mg total CoQ10

Investigational product 1 (IP1): CoQ10 in soybean oil, softgels

100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10

Group Type EXPERIMENTAL

Single dose intervention with Investigational product (IP1)

Intervention Type DIETARY_SUPPLEMENT

2 softgels - 200 mg total CoQ10

Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels

100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10

Group Type EXPERIMENTAL

Single dose intervention with Investigational product (IP2)

Intervention Type DIETARY_SUPPLEMENT

2 softgels - 200 mg total CoQ10

Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels

100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10

Group Type EXPERIMENTAL

Single dose intervention with Investigational product (IP3)

Intervention Type DIETARY_SUPPLEMENT

2 softgels - 200 mg total CoQ10

Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules

100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10

Group Type EXPERIMENTAL

Single dose intervention with Investigational product (IP4)

Intervention Type DIETARY_SUPPLEMENT

2 capsules - 200 mg total CoQ10

Interventions

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Single dose intervention with Standard product (SP)

2 capsules - 200 mg total CoQ10

Intervention Type DIETARY_SUPPLEMENT

Single dose intervention with Investigational product (IP1)

2 softgels - 200 mg total CoQ10

Intervention Type DIETARY_SUPPLEMENT

Single dose intervention with Investigational product (IP2)

2 softgels - 200 mg total CoQ10

Intervention Type DIETARY_SUPPLEMENT

Single dose intervention with Investigational product (IP3)

2 softgels - 200 mg total CoQ10

Intervention Type DIETARY_SUPPLEMENT

Single dose intervention with Investigational product (IP4)

2 capsules - 200 mg total CoQ10

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vizera d.o.o.

INDUSTRY

Sponsor Role collaborator

ADM, Ambulanta družinske medicine, Ljubljana, Slovenia

UNKNOWN

Sponsor Role collaborator

Adrialab d.o.o., Ljubljana, Slovenia

UNKNOWN

Sponsor Role collaborator

Tishcon Corp., USA

UNKNOWN

Sponsor Role collaborator

Institute of Nutrition, Slovenia (Nutris)

OTHER

Sponsor Role lead

Responsible Party

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Igor Pravst

Prof. Dr. Igor Pravst

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Igor Pravst

Role: PRINCIPAL_INVESTIGATOR

Nutrition Institute, Ljubljana

Tina Modrej Zadnikar

Role: PRINCIPAL_INVESTIGATOR

ADM, Ambulanta družinske medicine, Ljubljana, Slovenia

Locations

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ADM, ambulanta družinske medicine, Ljubljana, Slovenia

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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TISHCON/CoQ10-01

Identifier Type: -

Identifier Source: org_study_id