Skip to main content
OpenTrials
Completed

NCT Number: NCT05272228

Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products

The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coenzyme Q Deficiency Coenzyme Q10 Deficiency

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Primorska

Izola, 6310, Slovenia

About this study

The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products will include 25 subjects who will test three different coenzyme Q10 products. Serum concentration of coenzyme Q10 will be measured.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • subject informed consent form
  • aged between 40 and 55 years old
  • body mass for women 65± 5 kg and for men 85± 5 kg
  • non-smoking
  • healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases
  • absence of any prescribed medication during the study
  • willing to avoid a consumption of any food supplements at least 2 weeks before and during the study
  • willing to study all study procedures

Exclusion criteria

  • cardio-vascular diseases,
  • diabetes,
  • neurodegenerative diseases,
  • gastrointestinal disorders
  • hypotension
  • pregnancy
  • breast-feeding
  • intake of any prescribed medication within two week of the beginning of the study
  • intake of any food supplements within two week of the beginning of the study
  • drug or alcohol abuse

Treatment and study plan

Dietary supplement - standard product

Dietary Supplement

Single dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10

Dietary supplement - Investigational product IP1

Dietary Supplement

Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10

Dietary supplement - Investigational product IP2

Dietary Supplement

Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10

Primary outcomes

  1. Serum coenzyme Q10 concentrations

    Time frame: 0,2,4,6,8,12 and 24 hours after ingestion

    Serum coenzyme Q10 concentrations will me measured in all three different coenzyme Q10 products with ELISA kit for coenzyme Q10

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Collaborators

  • Biovis d.o.o.

Registry information

Official study title

The Single-centre, Randomized, Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2022
Registry last updated
Jul 21, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.