Study With Two Coenzyme Q10 Products (Co10_2024)

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

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

Study Overview

• Status: Completed
• Conditions: Coenzyme Q Deficiency
• Intervention / Treatment: Dietary supplement: Dietary supplement - Experimental product; Dietary supplement: Dietary supplement - Active comparator

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Izola
    • Izola, Izola, Slovenia, 6310
      • University of Primorska, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coenzyme Q10 (ubiquinone); Synonyms: Maltodextrin, capsule (HPMC - hydroxypropyl methyl cellulose), coenzyme Q10 (ubiquinone); Dosage: 2 capsules, total 100 mg Co-Q10	Dietary supplement: Dietary supplement - Experimental product; Single dose intervention with Experimental product; BMT® coenzyme Q10; 2 capsules - 100 mg total coenzyme Q10
Experimental: BMT® coenzyme Q10; Maltodextrin, BMT® coenzyme Q10 [maltodextrin, coenzyme Q10 (ubiquinone), stabiliser (gum arabic), corn starch, olive oil, anti-caking agent (silicon dioxide), acidity regulators (acetic acid, citric acid)], capsule (HPMC - hydroxypropyl methyl cellulose); Dosage: 2 capsules, total 100 mg Co-Q10	Dietary supplement: Dietary supplement - Active comparator; Single dose intervention with Standard product Coenzyme Q10 (ubiquinone); 2 capsules - 100 mg total coenzyme Q10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma levels of Coenzyme Q10	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.	At Baseline
Plasma levels of Coenzyme Q10	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.	Four hours after consumption
Plasma levels of Coenzyme Q10	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.	Six hours after consumption
Plasma levels of Coenzyme Q10	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.	Twelve hours after consumption
Plasma levels of Coenzyme Q10	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.	Twenty-four hours after consumption
Plasma levels of Coenzyme Q10	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.	Forthy-eight hours after consumption

Collaborators and Investigators

• Sponsor: University of Primorska
• Collaborators: Biostile d.o.o.; QFarm s.r.l.
• Investigators: Principal Investigator: Ana Petelin, PhD, University of Primorska, Faculty of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Actual): December 16, 2024
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Coenzyme Q10; single dose bioavailability
• Additional Relevant MeSH Terms: Coenzyme Q10 Deficiency
• Other Study ID Numbers: Q10_2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No