Clinical trial NCT04780074: Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations
Official title: Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability of Coenzyme Q10
Keywords: coenzyme q10
single dose bioavailability
Lead sponsor: Nutrition Institute, Slovenia
Sponsor class: OTHER
Collaborators: name: Vizera d.o.o.
name: ADM, Ambulanta družinske medicine, Ljubljana, Slovenia
name: Adrialab d.o.o., Ljubljana, Slovenia
name: Tishcon Corp., USA
First posted: 2021-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Subjects will test 5 formulations of single dose CoQ10 with 2 week wash-out. to assess bioavailability.
Primary purpose: OTHER

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 assess bioavailability.

Eligibility criteria: 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

Primary outcomes:
measure: Relative single dose bioavailability (AUC48) of IP (in comparison to SP)
timeFrame: 72 hours
Secondary outcomes:
measure: Relative single dose bioavailability (AUCinf) of IP (in comparison to SP)
timeFrame: 72 hours
Other outcomes:
measure: Relative single dose bioavailability (AUC48) among all the investigational products
timeFrame: 72 hours
measure: Relative single dose bioavailability (AUCinf) among all investigational products
timeFrame: 72 hours
Locations:
city: Ljubljana
country: Slovenia
facility: ADM, ambulanta družinske medicine, Ljubljana, Slovenia
Study officials:
affiliation: Nutrition Institute, Ljubljana
name: Igor Pravst
role: PRINCIPAL_INVESTIGATOR
affiliation: ADM, Ambulanta družinske medicine, Ljubljana, Slovenia
name: Tina Modrej Zadnikar
role: PRINCIPAL_INVESTIGATOR
References: