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Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

Sponsored by Nutrition Institute, Slovenia

About this trial

Last updated 3 years ago

Study ID

TISHCON/CoQ10-01

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Trial Timing

Ended 3 years ago

What is this trial about?

The single-center, randomized, open-label, five-period crossover single-dose bioavailability study with five CoQ10 formulations

What are the participation requirements?

Yes

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)

No

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

Locations

Location

Status