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

Single-dose and Multiple-dose Comparative Bioavailability Study of Three CoQ10 Formulations in Healthy Elderly Adults

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.

Study Overview

• Status: Completed
• Conditions: Bioavailability of Coenzyme Q10
• Intervention / Treatment: Dietary supplement: Single dose intervention with Standard product (SP); Dietary supplement: Single dose intervention with Comparative product (CP); Dietary supplement: Single dose intervention with Investigational product (IP); Dietary supplement: Multiple dose intervention with Standard product (SP); Dietary supplement: Multiple dose intervention with Comparative product (CP); Dietary supplement: Multiple dose intervention with Investigational product (IP)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Nutrition Institute, Ljubljana
  • Ljubljana, Slovenia, 1000
    • MEDEDUS, Ljubljana, Slovenia
  • Ljubljana, Slovenia, 1000
    • Vizera d.o.o., Ljubljana, Slovenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 72 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard product group; 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)	Dietary supplement: Single dose intervention with Standard product (SP); hard capsules, 100 mg; Dietary supplement: Single dose intervention with Comparative product (CP); soft-gel capsules, 100 mg; Dietary supplement: Single dose intervention with Investigational product (IP); syrup, 100 mg; Dietary supplement: Multiple dose intervention with Standard product (SP); hard capsules, 100 mg - 14 days
Active Comparator: Comparative product group; 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)	Dietary supplement: Single dose intervention with Standard product (SP); hard capsules, 100 mg; Dietary supplement: Single dose intervention with Comparative product (CP); soft-gel capsules, 100 mg; Dietary supplement: Single dose intervention with Investigational product (IP); syrup, 100 mg; Dietary supplement: Multiple dose intervention with Comparative product (CP); soft-gel capsules, 100 mg - 14 days
Experimental: Investigational product group; 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)	Dietary supplement: Single dose intervention with Standard product (SP); hard capsules, 100 mg; Dietary supplement: Single dose intervention with Comparative product (CP); soft-gel capsules, 100 mg; Dietary supplement: Multiple dose intervention with Investigational product (IP); syrup, 100 mg - 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improved single dose bioavailability of IP (in comparison to SP)	Relative bioavailability between the investigational and standard product expressed as ratio of AUC0-48h (area under the plasma concentration curve from the administration time to the last observation point, i.e. 48h) of total CoQ10 plasma concentrations above the baseline value.	48 hours
improved plasma CoQ10 level after multiple dose study for IP (in comparison to SP)	Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational and standard product.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparable single dose bioavailability of IP (in comparison to CP)	Relative bioavailability between the investigational product and comparator expressed as ratio of AUC0-48h of total CoQ10 plasma concentrations above the baseline value.	48 hours
comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP)	Ratio between total CoQ10 trough plasma concentrations after multiple-dose application on day 14 (CMIN,day14) between the investigational product and comparator.	14 days

Collaborators and Investigators

• Sponsor: Nutrition Institute, Slovenia
• Collaborators: MEDEDUS, Ljubljana, Slovenia; Vizera d.o.o.; Valens Int. d.o.o., Slovenija
• Investigators: Principal Investigator: Igor Pravst, Nutrition Institute, Ljubljana; Principal Investigator: Snežana Kocijančič, MEDEDUS, Ljubljana, Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): October 20, 2017
• Study Completion (Actual): October 20, 2017

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: coenzyme q10; single dose bioavailability; multiple dose bioavailability
• Other Study ID Numbers: KME 89/07/17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No