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NCT Number: NCT06736366

Study With Two Coenzyme Q10 Products

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

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Key information

Conditions

Coenzyme Q Deficiency Coenzyme Q10 Deficiency

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Primorska, Faculty of Health Sciences

Izola, Municipality of Izola, 6310, Slovenia

About this study

The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products will include 35 subjects who will test two different coenzyme Q10 products. Plasma 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 50 and 65 years old
  • body mass for women 70± 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

Exclusion criteria

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

Treatment and study plan

Dietary supplement - Active comparator

Dietary Supplement

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

Dietary supplement - Experimental product

Dietary Supplement

Single dose intervention with Experimental product; BMT® coenzyme Q10; 2 capsules - 100 mg total coenzyme Q10

Primary outcomes

  1. Plasma levels of Coenzyme Q10

    Time frame: At Baseline

    Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.

  2. Plasma levels of Coenzyme Q10

    Time frame: Four hours after consumption

    Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.

  3. Plasma levels of Coenzyme Q10

    Time frame: Six hours after consumption

    Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.

  4. Plasma levels of Coenzyme Q10

    Time frame: Twelve hours after consumption

    Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.

  5. Plasma levels of Coenzyme Q10

    Time frame: Twenty-four hours after consumption

    Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.

  6. Plasma levels of Coenzyme Q10

    Time frame: Forthy-eight hours after consumption

    Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Collaborators

  • Biostile
  • QFarm s.r.l.

Registry information

Official study title

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

Acronym: Co10_2024

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Dec 5, 2025

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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