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NCT Number: NCT04780074

Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

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

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Key information

Conditions

Bioavailability of Coenzyme Q10

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ADM, ambulanta družinske medicine, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single dose intervention with Standard product (SP)

Dietary Supplement

2 capsules - 200 mg total CoQ10

Single dose intervention with Investigational product (IP1)

Dietary Supplement

2 softgels - 200 mg total CoQ10

Single dose intervention with Investigational product (IP2)

Dietary Supplement

2 softgels - 200 mg total CoQ10

Single dose intervention with Investigational product (IP3)

Dietary Supplement

2 softgels - 200 mg total CoQ10

Single dose intervention with Investigational product (IP4)

Dietary Supplement

2 capsules - 200 mg total CoQ10

Primary outcomes

  1. 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 outcomes

  1. 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.

Other outcomes

  1. Relative single dose bioavailability (AUC48) among all the investigational products

    Time frame: 72 hours

    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.

  2. Relative single dose bioavailability (AUCinf) among all investigational products

    Time frame: 72 hours

    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.

Sponsors and collaborators

Lead sponsor

Institute of Nutrition, Slovenia (Nutris)

Other

Collaborators

  • ADM, Ambulanta družinske medicine, Ljubljana, Slovenia
  • Adrialab d.o.o., Ljubljana, Slovenia
  • Tishcon Corp., USA
  • Vizera d.o.o.

Registry information

Official study title

Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations in Healthy Adults

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 3, 2021
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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