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

University of Primorska

Status: Completed

Conditions: Coenzyme Q Deficiency

Treatments: Dietary Supplement: Dietary supplement - Investigational product IP2; Dietary Supplement: Dietary supplement - Investigational product IP1; Dietary Supplement: Dietary supplement - standard product

Study type: Interventional

Funder types: Other

Identifiers

NCT05272228

CoenzymeQ10

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Coenzyme Q10 (ubiquinone)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Dietary supplement - standard product

Q10 MICROENCAPSULATED

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary supplement - Investigational product IP1

Final formulated product BQSM®

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary supplement - Investigational product IP2