Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
Not Applicable
Completed
- Conditions
- Coenzyme Q Deficiency
- Interventions
- Dietary Supplement: Dietary supplement - Investigational product IP1Dietary Supplement: Dietary supplement - standard productDietary Supplement: Dietary supplement - Investigational product IP2
- Registration Number
- NCT05272228
- Lead Sponsor
- University of Primorska
- Brief Summary
The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Q10 MICROENCAPSULATED Dietary supplement - Investigational product IP1 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 Coenzyme Q10 (ubiquinone) Dietary supplement - standard product 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 Final formulated product BQSM® Dietary supplement - Investigational product IP2 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
- Primary Outcome Measures
Name Time Method Serum coenzyme Q10 concentrations 0,2,4,6,8,12 and 24 hours after ingestion Serum coenzyme Q10 concentrations will me measured in all three different coenzyme Q10 products with ELISA kit for coenzyme Q10
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Primorska
🇸🇮Izola, Slovenia