Clinical trial NCT03284814: Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults
Official title: Single-dose and Multiple-dose Comparative Bioavailability Study of Three CoQ10 Formulations in Healthy Elderly Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability of Coenzyme Q10
Keywords: coenzyme q10
single dose bioavailability
multiple dose bioavailability
Lead sponsor: Nutrition Institute, Slovenia
Sponsor class: OTHER
Collaborators: name: Vizera d.o.o.
name: Valens Int. d.o.o., Slovenija
name: MEDEDUS, Ljubljana, Slovenia
First posted: 2017-09-15
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Maximum age (years): 74
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.
Primary purpose: OTHER

Brief summary: The single-center, randomized, open-label, three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.


Eligibility criteria: Inclusion Criteria:

* Subject Informed consent form (ICF) is singed
* Aged between 65 and 74 years at the time of the signature of ICF
* A body mass index between 20 and 29 kg/m2
* 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), and keeping a diary for the time of multiple-dose study (to follow their compliance and palatability)

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
* Hypotension
* Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or hematological 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: improved single dose bioavailability of IP (in comparison to SP)
timeFrame: 48 hours
measure: improved plasma CoQ10 level after multiple dose study for IP (in comparison to SP)
timeFrame: 14 days
Secondary outcomes:
measure: comparable single dose bioavailability of IP (in comparison to CP)
timeFrame: 48 hours
measure: comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP)
timeFrame: 14 days
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: MEDEDUS, Ljubljana, Slovenia
city: Ljubljana
country: Slovenia
facility: Nutrition Institute, Ljubljana
city: Ljubljana
country: Slovenia
facility: Vizera d.o.o., Ljubljana, Slovenia
Study officials:
affiliation: Nutrition Institute, Ljubljana
name: Igor Pravst
role: PRINCIPAL_INVESTIGATOR
affiliation: MEDEDUS, Ljubljana, Slovenia
name: Snežana Kocijančič
role: PRINCIPAL_INVESTIGATOR
References: