Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

Overview

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

Full Title of Study: “Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations in Healthy Adults”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Other
  • Masking: None (Open Label)
• Study Primary Completion Date: May 21, 2021

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.

Interventions

• Dietary Supplement: Single dose intervention with Standard product (SP)
  • 2 capsules – 200 mg total CoQ10
• Dietary Supplement: Single dose intervention with Investigational product (IP1)
  • 2 softgels – 200 mg total CoQ10
• Dietary Supplement: Single dose intervention with Investigational product (IP2)
  • 2 softgels – 200 mg total CoQ10
• Dietary Supplement: Single dose intervention with Investigational product (IP3)
  • 2 softgels – 200 mg total CoQ10
• Dietary Supplement: Single dose intervention with Investigational product (IP4)
  • 2 capsules – 200 mg total CoQ10

Arms, Groups and Cohorts

• Active Comparator: Standard product (SP): USP CoQ10 powder, hard capsules
  • 100 mg per capsule; dosage: 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
• Experimental: Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels
  • 100 mg per softgel; dosage: 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
• Experimental: Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules
  • 100 mg per capsule; dosage: 2 capsules – 200 mg total CoQ10

Clinical Trial Outcome Measures

Primary Measures

• 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.

Secondary Measures

• 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Nutrition Institute, Slovenia
• Collaborator
  • Vizera d.o.o.
• Provider of Information About this Clinical Study
  • Principal Investigator: Igor Pravst, Prof. Dr. Igor Pravst – Nutrition Institute, Slovenia
• Overall Official(s)
  • Igor Pravst, Principal Investigator, Nutrition Institute, Ljubljana
  • Tina Modrej Zadnikar, Principal Investigator, ADM, Ambulanta družinske medicine, Ljubljana, Slovenia