Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults

Launched by NUTRITION INSTITUTE, SLOVENIA · Sep 13, 2017

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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