Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

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: Completed
• Conditions: Bioavailability of Coenzyme Q10
• Intervention / Treatment: Dietary supplement: Single dose intervention with Standard product (SP); Dietary supplement: Single dose intervention with Investigational product (IP1); Dietary supplement: Single dose intervention with Investigational product (IP2); Dietary supplement: Single dose intervention with Investigational product (IP3); Dietary supplement: Single dose intervention with Investigational product (IP4)

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative single dose bioavailability (AUC48) among all the investigational products	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	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

• Sponsor: Nutrition Institute, Slovenia
• Collaborators: Vizera d.o.o.; ADM, Ambulanta družinske medicine, Ljubljana, Slovenia; Adrialab d.o.o., Ljubljana, Slovenia; Tishcon Corp., USA
• Investigators: Principal Investigator: Igor Pravst, Nutrition Institute, Ljubljana; Principal Investigator: Tina Modrej Zadnikar, ADM, ambulanta družinske medicine, Ljubljana, Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2021
• Primary Completion (Actual): May 21, 2021
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: coenzyme q10; single dose bioavailability
• Other Study ID 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