NCT05272228

Brief Summary

The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 9, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

February 28, 2022

Last Update Submit

July 18, 2022

Conditions

Coenzyme Q Deficiency

Keywords

coenzyme Q10single dose bioavailability

Outcome Measures

Primary Outcomes (1)

  • Serum coenzyme Q10 concentrations

    Serum coenzyme Q10 concentrations will me measured in all three different coenzyme Q10 products with ELISA kit for coenzyme Q10

    0,2,4,6,8,12 and 24 hours after ingestion

Study Arms (3)

Coenzyme Q10 (ubiquinone)

ACTIVE COMPARATOR

Synonyms: Co-Q10; Ubiquinone; Ubidecarenone; 2,5-Cyclohexadiene-1,4-dione, 2- \[(2E,6E,10E,14E,18E,22E,26E,30E,34E)-3,7,11,15,19,23,27,31,35,39-decamethyl-,6,10,14,18,22,26,30,34,38- tetracontadecaenyl\]-5,6-dimethoxy-3-methyl CAS number: 303-98-0 Molecular formula: C59H90O4 USP standard Content: Co-Q10 (ubiquinone), bulking agent (maltodextrin), capsule (HPCM- hydroxypropyl methyl cellulose), anti-adherents (magnesium stearate and anhydrous silica) Dosage: 2 capsules, total 100 mg Co-Q10

Dietary Supplement: Dietary supplement - standard product

Q10 MICROENCAPSULATED

EXPERIMENTAL

IP1:Q10 MICROENCAPSULATED. ENG: Ingredient BMT® Coenzyme Q10 Content Co-Q10 (ubiquinone), stabiliser (gum arabic), bulking agent (maltodextrin), capsule (HPCM- hydroxypropyl methyl cellulose), olive oil, corn starch, anti-adherents (magnesium stearate and anhydrous silica), acidity regulator (citric acid, acetic acid) HPMC capsules, size '0', 50 mg/capsule Dosage: 2 capsule, total 100 mg Co-Q10

Dietary Supplement: Dietary supplement - Investigational product IP1

Final formulated product BQSM®

EXPERIMENTAL

IP2: Final formulated product BQSM® Ingredients: Rosehip (Rosa canina) fruit extract standardised to min. 70 % of vitamin C (L-ascorbic acid), capsule (HPCM- hydroxypropyl methyl cellulose), BMT® Coenzyme Q10 (ubiquinone), vitamin E (D-alfa tocopheryl acetate), vitamin A (retinyl acetate), L-selenomethionine, bulking agent (maltodextrin), stabiliser (gum arabic), olive oil, corn starch, anti-adherents (magnesium stearate and anhydrous silica), acidity regulator (citric acid, acetic acid) HPMC capsule, size '0', 50 mg/capsule Dosage: 2 capsule, total 100 mg Co-Q10

Dietary Supplement: Dietary supplement - Investigational product IP2

Interventions

Dietary supplement - standard productDIETARY_SUPPLEMENT

Single dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10

Coenzyme Q10 (ubiquinone)
Dietary supplement - Investigational product IP1DIETARY_SUPPLEMENT

Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10

Q10 MICROENCAPSULATED
Dietary supplement - Investigational product IP2DIETARY_SUPPLEMENT

Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10

Final formulated product BQSM®

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • subject informed consent form
  • aged between 40 and 55 years old
  • body mass for women 65± 5 kg and for men 85± 5 kg
  • non-smoking
  • healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases
  • absence of any prescribed medication during the study
  • willing to avoid a consumption of any food supplements at least 2 weeks before and during the study
  • willing to study all study procedures

You may not qualify if:

  • cardio-vascular diseases,
  • diabetes,
  • neurodegenerative diseases,
  • gastrointestinal disorders
  • hypotension
  • pregnancy
  • breast-feeding
  • intake of any prescribed medication within two week of the beginning of the study
  • intake of any food supplements within two week of the beginning of the study
  • drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Primorska

Izola, 6310, Slovenia

Location

MeSH Terms

Conditions

Coenzyme Q10 Deficiency

Study Officials

  • Zala Jenko-Pražnikar, PhD

    University of Primorska, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, PhD

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 9, 2022

Study Start

March 9, 2022

Primary Completion

May 15, 2022

Study Completion

July 15, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)