Study With Two Coenzyme Q10 Products

NCT06736366 | Completed

• 1 other identifier: Q10_2024
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coenzyme Q Deficiency

Keywords

single dose bioavailability; Coenzyme Q10

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Coenzyme Q10 (ubiquinone)

ACTIVE COMPARATOR

Synonyms: Maltodextrin, capsule (HPMC - hydroxypropyl methyl cellulose), coenzyme Q10 (ubiquinone); Dosage: 2 capsules, total 100 mg Co-Q10

Dietary Supplement: Dietary supplement - Experimental product

BMT® coenzyme Q10

EXPERIMENTAL

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

Interventions

Dietary supplement - Active comparator DIETARY_SUPPLEMENT

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

BMT® coenzyme Q10

Dietary supplement - Experimental product DIETARY_SUPPLEMENT

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

Coenzyme Q10 (ubiquinone)

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Primorska: lead
• Biostile d.o.o.: collaborator
• QFarm s.r.l.: collaborator

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, Municipality of Izola, 6310, Slovenia

Location

MeSH Terms

Conditions

Coenzyme Q10 Deficiency

Study Officials

• Ana Petelin, phD

  University of Primorska, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: December 5, 2024
• Primary Completion: December 16, 2024
• Study Completion: June 30, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)