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

The Single-centre, Randomized, 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

Study Overview

• Status: Completed
• Conditions: Coenzyme Q Deficiency
• Intervention / Treatment: Dietary supplement: Dietary supplement - standard product; Dietary supplement: Dietary supplement - Investigational product IP1; Dietary supplement: Dietary supplement - Investigational product IP2

Detailed Description

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.

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

Contacts and Locations

Study Locations

• Slovenia
  • Izola, Slovenia, 6310
    • University of Primorska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coenzyme Q10 (ubiquinone); Synonyms: Co-Q10; Ubiquinone; Ubidecarenone; 2,5-Cyclohexadiene-1,4-dione, 2- [(2E,6E,10E,14E,18E,22E,26E,30E,34E)-3,7,11,15,19,23,27,31,35,39-decamethyl-,6,10,14,18,22,26,30,34,38- tetracontadecaenyl]-5,6-dimethoxy-3-methyl CAS number: 303-98-0 Molecular formula: C59H90O4 USP standard Content: Co-Q10 (ubiquinone), bulking agent (maltodextrin), capsule (HPCM- hydroxypropyl methyl cellulose), anti-adherents (magnesium stearate and anhydrous silica) Dosage: 2 capsules, total 100 mg Co-Q10	Dietary supplement: Dietary supplement - standard product; Single dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10
Experimental: Q10 MICROENCAPSULATED; IP1:Q10 MICROENCAPSULATED. ENG: Ingredient BMT® Coenzyme Q10 Content Co-Q10 (ubiquinone), stabiliser (gum arabic), bulking agent (maltodextrin), capsule (HPCM- hydroxypropyl methyl cellulose), olive oil, corn starch, anti-adherents (magnesium stearate and anhydrous silica), acidity regulator (citric acid, acetic acid) HPMC capsules, size '0', 50 mg/capsule Dosage: 2 capsule, total 100 mg Co-Q10	Dietary supplement: Dietary supplement - Investigational product IP1; Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10
Experimental: Final formulated product BQSM®; IP2: Final formulated product BQSM® Ingredients: Rosehip (Rosa canina) fruit extract standardised to min. 70 % of vitamin C (L-ascorbic acid), capsule (HPCM- hydroxypropyl methyl cellulose), BMT® Coenzyme Q10 (ubiquinone), vitamin E (D-alfa tocopheryl acetate), vitamin A (retinyl acetate), L-selenomethionine, bulking agent (maltodextrin), stabiliser (gum arabic), olive oil, corn starch, anti-adherents (magnesium stearate and anhydrous silica), acidity regulator (citric acid, acetic acid) HPMC capsule, size '0', 50 mg/capsule Dosage: 2 capsule, total 100 mg Co-Q10	Dietary supplement: Dietary supplement - Investigational product IP2; Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum coenzyme Q10 concentrations	Serum coenzyme Q10 concentrations will me measured in all three different coenzyme Q10 products with ELISA kit for coenzyme Q10	0,2,4,6,8,12 and 24 hours after ingestion

Collaborators and Investigators

• Sponsor: University of Primorska
• Collaborators: Biovis d.o.o.
• Investigators: Principal Investigator: Zala Jenko-Pražnikar, PhD, University of Primorska, Faculty of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: coenzyme Q10; single dose bioavailability
• Other Study ID Numbers: CoenzymeQ10

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