Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults (CoQ10-01)

Nutrition Institute, Slovenia

Status: Completed

Conditions: Bioavailability of Coenzyme Q10

Treatments: Dietary Supplement: Multiple dose intervention with Comparative product (CP); Dietary Supplement: Multiple dose intervention with Standard product (SP); Dietary Supplement: Single dose intervention with Standard product (SP); Dietary Supplement: Multiple dose intervention with Investigational product (IP); Dietary Supplement: Single dose intervention with Comparative product (CP); Dietary Supplement: Single dose intervention with Investigational product (IP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03284814

KME 89/07/17

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 65 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Standard product group

Active Comparator group

Description:

This group will be included in a single dose cross over study, and in multiple dose study with standard product (SP: CoQ10 hard capsules; 100 mg)

Treatment:

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

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

Dietary Supplement: Single dose intervention with Comparative product (CP)

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

Comparative product group

Active Comparator group

Description:

This group will be included in a single dose cross over study, and in multiple dose study with comparative product (CP: CoQ10 soft-gel capsules; 100 mg)

Treatment:

Dietary Supplement: Multiple dose intervention with Comparative product (CP)

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

Dietary Supplement: Single dose intervention with Comparative product (CP)

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

Investigational product group

Experimental group

Description:

This group will be included in a single dose cross over study, and in multiple dose study with investigational product (IP: CoQ10 syrup; 100 mg)

Treatment:

Dietary Supplement: Single dose intervention with Comparative product (CP)

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

Dietary Supplement: Multiple dose intervention with Investigational product (IP)