Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults

NCT03284814 | Completed

• 1 other identifier: KME 89/07/17
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Bioavailability of Coenzyme Q10

Keywords

coenzyme q10; single dose bioavailability; multiple dose bioavailability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• comparable single dose bioavailability of IP (in comparison to CP)

  48 hours

• comparable plasma CoQ10 level after multiple dose study for IP (in comparison to CP)

  14 days

Study Arms (3)

Standard product group

ACTIVE COMPARATOR

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); 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)

Comparative product group

ACTIVE COMPARATOR

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

Investigational product group

EXPERIMENTAL

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

Interventions

Single dose intervention with Standard product (SP) DIETARY_SUPPLEMENT

hard capsules, 100 mg

Comparative product group; Investigational product group; Standard product group

Single dose intervention with Comparative product (CP) DIETARY_SUPPLEMENT

soft-gel capsules, 100 mg

Comparative product group; Investigational product group; Standard product group

Single dose intervention with Investigational product (IP) DIETARY_SUPPLEMENT

syrup, 100 mg

Comparative product group; Standard product group

Multiple dose intervention with Standard product (SP) DIETARY_SUPPLEMENT

hard capsules, 100 mg - 14 days

Standard product group

Multiple dose intervention with Comparative product (CP) DIETARY_SUPPLEMENT

soft-gel capsules, 100 mg - 14 days

Comparative product group

Multiple dose intervention with Investigational product (IP) DIETARY_SUPPLEMENT

syrup, 100 mg - 14 days

Investigational product group

Eligibility Criteria

• Age: 65 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• Vizera d.o.o.: collaborator
• Valens Int. d.o.o., Slovenija: collaborator
• MEDEDUS, Ljubljana, Slovenia: collaborator

Study Sites (3)

MEDEDUS, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

Location

Nutrition Institute, Ljubljana

Ljubljana, 1000, Slovenia

Location

Vizera d.o.o., Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Igor Pravst

  Nutrition Institute, Ljubljana

  PRINCIPAL INVESTIGATOR

• Snežana Kocijančič

  MEDEDUS, Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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 Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: August 29, 2017
• Primary Completion: October 20, 2017
• Study Completion: October 20, 2017
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

SL (3)