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Completed

NCT Number: NCT03284814

Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults

The single-center, randomized, open-label, three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.

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Key information

Conditions

Bioavailability of Coenzyme Q10

Age range

65 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MEDEDUS, Ljubljana, Slovenia, Ljubljana, Slovenia

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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 65 and 74 years at the time of the signature of ICF
  • A body mass index between 20 and 29 kg/m2
  • 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), and keeping a diary for the time of multiple-dose study (to follow their compliance and palatability)

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
  • Hypotension
  • Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or hematological 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

hard capsules, 100 mg

Single dose intervention with Comparative product (CP)

Dietary Supplement

soft-gel capsules, 100 mg

Single dose intervention with Investigational product (IP)

Dietary Supplement

syrup, 100 mg

Multiple dose intervention with Standard product (SP)

Dietary Supplement

hard capsules, 100 mg - 14 days

Multiple dose intervention with Comparative product (CP)

Dietary Supplement

soft-gel capsules, 100 mg - 14 days

Multiple dose intervention with Investigational product (IP)

Dietary Supplement

syrup, 100 mg - 14 days

Primary outcomes

  1. improved single dose bioavailability of IP (in comparison to SP)

    Time frame: 48 hours

    Relative bioavailability between the investigational and standard product expressed as ratio of AUC0-48h (area under the plasma concentration curve from the administration time to the last observation point, i.e. 48h) of total CoQ10 plasma concentrations above the baseline value.

  2. improved plasma CoQ10 level after multiple dose study for IP (in comparison to SP)

    Time frame: 14 days

    Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational and standard product.

Secondary outcomes

  1. comparable single dose bioavailability of IP (in comparison to CP)

    Time frame: 48 hours

    Relative bioavailability between the investigational product and comparator expressed as ratio of AUC0-48h of total CoQ10 plasma concentrations above the baseline value.

  2. comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP)

    Time frame: 14 days

    Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational product and comparator.

Sponsors and collaborators

Lead sponsor

Institute of Nutrition, Slovenia (Nutris)

Other

Collaborators

  • MEDEDUS, Ljubljana, Slovenia
  • Valens Int. d.o.o., Slovenija
  • Vizera d.o.o.

Registry information

Official study title

Single-dose and Multiple-dose Comparative Bioavailability Study of Three CoQ10 Formulations in Healthy Elderly Adults

Acronym: CoQ10-01

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2017
Registry last updated
Mar 20, 2019

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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