Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

Bioavailability of Coenzyme Q10 Clinical Trial

Official title:

Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780074
• Other study ID #: TISHCON/CoQ10-01
• Status: Completed
• Phase: N/A
• Start date: February 28, 2021
• Est. completion date: December 13, 2022

Study information

• Verified date: December 2022
• Source: Nutrition Institute, Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 13, 2022
• Est. primary completion date: May 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability of Coenzyme Q10

Intervention

Dietary Supplement:
• Single dose intervention with Standard product (SP)
2 capsules - 200 mg total CoQ10
• Single dose intervention with Investigational product (IP1)
2 softgels - 200 mg total CoQ10
• Single dose intervention with Investigational product (IP2)
2 softgels - 200 mg total CoQ10
• Single dose intervention with Investigational product (IP3)
2 softgels - 200 mg total CoQ10
• Single dose intervention with Investigational product (IP4)
2 capsules - 200 mg total CoQ10

Locations

Country	Name	City	State
Slovenia	ADM, ambulanta družinske medicine, Ljubljana, Slovenia	Ljubljana

Sponsors (5)

Lead Sponsor	Collaborator
Nutrition Institute, Slovenia	ADM, Ambulanta družinske medicine, Ljubljana, Slovenia, Adrialab d.o.o., Ljubljana, Slovenia, Tishcon Corp., USA, Vizera d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relative single dose bioavailability (AUC48) among all the investigational products	Relative bioavailability among all the investigational products (IP1 vs. IP2, IP1 vs. IP3, IP1 vs. IP4, IP2 vs. IP3, IP2 vs. IP4, and IP3 vs. IP4) expressed as ratio of baseline corrected AUC0-72h, i.e. area under the plasma concentration curve from the administration time to the last observation point (72h) of CoQ10 plasma concentrations above the baseline value.	72 hours
Other	Relative single dose bioavailability (AUCinf) among all investigational products	Relative bioavailability among all investigational products (IP1 vs. IP2, IP1 vs. IP3, IP1 vs. IP4, IP2 vs. IP3, IP2 vs. IP4, and IP3 vs. IP4) expressed as ratio of baseline corrected AUCinf, i.e. extrapolated area under the CoQ10 plasma concentration curve above the baseline CoQ10 concentration.	72 hours
Primary	Relative single dose bioavailability (AUC48) of IP (in comparison to SP)	Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUC0-72h, i.e. area under the plasma concentration curve from the administration time to the last observation point (72h) of CoQ10 plasma concentrations above the baseline value.	72 hours
Secondary	Relative single dose bioavailability (AUCinf) of IP (in comparison to SP)	Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUCinf, i.e. extrapolated area under the CoQ10 plasma concentration curve above the baseline CoQ10 concentration.	72 hours