Status:
COMPLETED
Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults
Lead Sponsor:
Institute of Nutrition, Slovenia (Nutris)
Collaborating Sponsors:
Vizera d.o.o.
Valens Int. d.o.o., Slovenija
Conditions:
Bioavailability of Coenzyme Q10
Eligibility:
All Genders
65-74 years
Phase:
NA
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 dos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03284814
Start Date
August 29 2017
End Date
October 20 2017
Last Update
March 20 2019
Active Locations (3)
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1
MEDEDUS, Ljubljana, Slovenia
Ljubljana, Slovenia, 1000
2
Nutrition Institute, Ljubljana
Ljubljana, Slovenia, 1000
3
Vizera d.o.o., Ljubljana, Slovenia
Ljubljana, Slovenia, 1000