Coenzyme Q Deficiency
Conditions
Keywords
coenzyme Q10, single dose bioavailability
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.
Interventions
DIETARY_SUPPLEMENTDietary supplement - standard product
Single dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10
DIETARY_SUPPLEMENTDietary supplement - Investigational product IP1
Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10
DIETARY_SUPPLEMENTDietary supplement - Investigational product IP2
Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10
Sponsors
Biovis d.o.o.
University of Primorska
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Slovenia
Outcome results
None listed