Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

Nutrition Institute, Slovenia

Status: Completed

Conditions: Bioavailability of Coenzyme Q10

Treatments: Dietary Supplement: Single dose intervention with Investigational product (IP4); Dietary Supplement: Single dose intervention with Investigational product (IP2); Dietary Supplement: Single dose intervention with Investigational product (IP1); Dietary Supplement: Single dose intervention with Standard product (SP); Dietary Supplement: Single dose intervention with Investigational product (IP3)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04780074

TISHCON/CoQ10-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Standard product (SP): USP CoQ10 powder, hard capsules

Active Comparator group

Description:

100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10

Treatment:

Dietary Supplement: Single dose intervention with Standard product (SP)

Investigational product 1 (IP1): CoQ10 in soybean oil, softgels

Experimental group

Description:

100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10

Treatment:

Dietary Supplement: Single dose intervention with Investigational product (IP1)

Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels

Experimental group

Description:

100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10

Treatment:

Dietary Supplement: Single dose intervention with Investigational product (IP2)

Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels

Experimental group

Description:

100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10

Treatment:

Dietary Supplement: Single dose intervention with Investigational product (IP3)

Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules

Experimental group

Description:

100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10

Treatment:

Dietary Supplement: Single dose intervention with Investigational product (IP4)