Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

Not Applicable

Completed

• Conditions: Bioavailability of Coenzyme Q10
• Interventions: Dietary Supplement: Single dose intervention with Investigational product (IP2); Dietary Supplement: Single dose intervention with Investigational product (IP1); Dietary Supplement: Single dose intervention with Standard product (SP); Dietary Supplement: Single dose intervention with Investigational product (IP3); Dietary Supplement: Single dose intervention with Investigational product (IP4)

• Registration Number: NCT04780074
• Lead Sponsor: Nutrition Institute, Slovenia

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-27
• Study Start: 2021-02-28
• Study First Posted: 2021-03-03
• Primary Completion: 2021-05-21
• Status Verified: 2022-12
• Study Completion: 2022-12-13
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels	Single dose intervention with Investigational product (IP2)	100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Investigational product 1 (IP1): CoQ10 in soybean oil, softgels	Single dose intervention with Investigational product (IP1)	100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10
Standard product (SP): USP CoQ10 powder, hard capsules	Single dose intervention with Standard product (SP)	100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10
Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels	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	Single dose intervention with Investigational product (IP4)	100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10

Primary Outcome Measures

Name	Time	Method
Relative single dose bioavailability (AUC48) of IP (in comparison to SP)	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.

Secondary Outcome Measures

Name	Time	Method
Relative single dose bioavailability (AUCinf) of IP (in comparison to SP)	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.

Trial Locations

Locations (1)

ADM, ambulanta družinske medicine, Ljubljana, Slovenia; 🇸🇮 Ljubljana, Slovenia