Status:
COMPLETED
Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations
Lead Sponsor:
Institute of Nutrition, Slovenia (Nutris)
Collaborating Sponsors:
Vizera d.o.o.
ADM, Ambulanta družinske medicine, Ljubljana, Slovenia
Conditions:
Bioavailability of Coenzyme Q10
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The single-center, randomized, open-label, five-period crossover single-dose bioavailability study with five CoQ10 formulations
Detailed Description
The single-center, randomized, open-label, five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Study will be conducted with single dose CoQ10 to...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subject Informed consent form (ICF) is singed
- Aged between 18 and 65 years at the time of the signature of ICF
- A body mass index between 18.5-29.9 kg/m2
- Total blood cholesterol range 3,11 - 6,50 mmol/L (not treated with medications)
- Healthy, meaning absence of any prescribed medication for a month prior to the inclusion to the study and during the study
- Willing to avoid a consumption of any food supplements except vitamin D and calcium at least 2 weeks before and during the study
- Consumption of dairy and cereal products (standardised breakfast will include low lactose dairy and bread)
- Willing to follow all study procedures, including attending all site visits (including sessions during which a venous line will be inserted for blood sampling)
- Exclusion criteria:
- Intake of any prescribed medication within 2 weeks of the beginning of the study
- Intake of any food supplements within 2 weeks of the beginning of the study, except vitamin D and calcium
- Pregnancy or planned pregnancy
- Breast-feeding mother
- Hypotension
- Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or haematological disease, diabetes
- Gastrointestinal disorders or other serious acute or chronic diseases
- Known lactose/gluten intolerances/ food allergies (limitation for standardisation of meals)
- Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
- Known drug and/or alcohol abuse
- Using any form of nicotine or tobacco
- Mental incapacity that precludes adequate understanding or cooperation
- Participation in another investigational study or blood donation within 3 months prior to or during this study
Exclusion
Key Trial Info
Start Date :
February 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04780074
Start Date
February 28 2021
End Date
December 13 2022
Last Update
December 14 2022
Active Locations (1)
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1
ADM, ambulanta družinske medicine, Ljubljana, Slovenia
Ljubljana, Slovenia, 1000