Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

NCT04780074 | Completed

• 1 other identifier: TISHCON/CoQ10-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bioavailability of Coenzyme Q10

Keywords

coenzyme q10; single dose bioavailability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relative single dose bioavailability (AUCinf) of IP (in comparison to SP)

  72 hours

Other Outcomes (2)

• Relative single dose bioavailability (AUC48) among all the investigational products

  72 hours

• Relative single dose bioavailability (AUCinf) among all investigational products

  72 hours

Study Arms (5)

Standard product (SP): USP CoQ10 powder, hard capsules

ACTIVE COMPARATOR

100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10

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

Investigational product 1 (IP1): CoQ10 in soybean oil, softgels

EXPERIMENTAL

100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10

Dietary Supplement: Single dose intervention with Investigational product (IP1)

Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels

EXPERIMENTAL

100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10

Dietary Supplement: Single dose intervention with Investigational product (IP2)

Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels

EXPERIMENTAL

100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10

Dietary Supplement: Single dose intervention with Investigational product (IP3)

Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules

EXPERIMENTAL

100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10

Dietary Supplement: Single dose intervention with Investigational product (IP4)

Interventions

Single dose intervention with Standard product (SP) DIETARY_SUPPLEMENT

2 capsules - 200 mg total CoQ10

Standard product (SP): USP CoQ10 powder, hard capsules

Single dose intervention with Investigational product (IP1) DIETARY_SUPPLEMENT

2 softgels - 200 mg total CoQ10

Investigational product 1 (IP1): CoQ10 in soybean oil, softgels

Single dose intervention with Investigational product (IP2) DIETARY_SUPPLEMENT

2 softgels - 200 mg total CoQ10

Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels

Single dose intervention with Investigational product (IP3) DIETARY_SUPPLEMENT

2 softgels - 200 mg total CoQ10

Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels

Single dose intervention with Investigational product (IP4) DIETARY_SUPPLEMENT

2 capsules - 200 mg total CoQ10

Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

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
• 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

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• Vizera d.o.o.: collaborator
• ADM, Ambulanta družinske medicine, Ljubljana, Slovenia: collaborator
• Adrialab d.o.o., Ljubljana, Slovenia: collaborator
• Tishcon Corp., USA: collaborator

Study Sites (1)

ADM, ambulanta družinske medicine, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Interventions

Methods; I-kappa B Kinase

Intervention Hierarchy (Ancestors)

Investigative Techniques; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Igor Pravst

  Nutrition Institute, Ljubljana

  PRINCIPAL INVESTIGATOR

• Tina Modrej Zadnikar

  ADM, Ambulanta družinske medicine, 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: Prof. Dr. Igor Pravst

Model Details: Five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Subjects will test 5 formulations of single dose CoQ10 with 2 week wash-out. to assess bioavailability.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 3, 2021
• Study Start: February 28, 2021
• Primary Completion: May 21, 2021
• Study Completion: December 13, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)