Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults

Bioavailability of Coenzyme Q10 Clinical Trial

— CoQ10-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284814
• Other study ID #: KME 89/07/17
• Status: Completed
• Phase: N/A
• Start date: August 29, 2017
• Est. completion date: October 20, 2017

Study information

• Verified date: March 2019
• Source: Nutrition Institute, Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 20, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability of Coenzyme Q10

Intervention

Dietary Supplement:
• Single dose intervention with Standard product (SP)
hard capsules, 100 mg
• Single dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg
• Single dose intervention with Investigational product (IP)
syrup, 100 mg
• Multiple dose intervention with Standard product (SP)
hard capsules, 100 mg - 14 days
• Multiple dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg - 14 days
• Multiple dose intervention with Investigational product (IP)
syrup, 100 mg - 14 days

Locations

Country	Name	City	State
Slovenia	MEDEDUS, Ljubljana, Slovenia	Ljubljana
Slovenia	Nutrition Institute, Ljubljana	Ljubljana
Slovenia	Vizera d.o.o., Ljubljana, Slovenia	Ljubljana

Sponsors (4)

Lead Sponsor	Collaborator
Nutrition Institute, Slovenia	MEDEDUS, Ljubljana, Slovenia, Valens Int. d.o.o., Slovenija, Vizera d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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