Clincosm LogoSign in Get a demo

Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products

Sponsor
University of Primorska (Other)
Overall Status
Completed
CT.gov ID
NCT05272228
Collaborator
Biovis d.o.o. (Other)
25
Enrollment
1
Location
3
Arms
4.2
Actual Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dietary supplement - standard product
  • Dietary Supplement: Dietary supplement - Investigational product IP1
  • Dietary Supplement: Dietary supplement - Investigational product IP2
 N/A

Detailed Description

The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products will include 25 subjects who will test three different coenzyme Q10 products. Serum concentration of coenzyme Q10 will be measured.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
The Single-centre, Randomized, Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
Actual Study Start Date :
Mar 9, 2022
Actual Primary Completion Date :
May 15, 2022
Actual Study Completion Date :
Jul 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Coenzyme Q10 (ubiquinone)

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

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
Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10
Experimental: Final formulated product BQSM®

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

Outcome Measures

Primary Outcome Measures

  1. Serum coenzyme Q10 concentrations [0,2,4,6,8,12 and 24 hours after ingestion]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Primorska Izola Slovenia 6310

Sponsors and Collaborators

  • University of Primorska
  • Biovis d.o.o.

Investigators

  • Principal Investigator: Zala Jenko-Pražnikar, PhD, University of Primorska, Faculty of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zala Jenko Praznikar, Associate Professor, PhD, University of Primorska
ClinicalTrials.gov Identifier:
NCT05272228
Other Study ID Numbers:
  • CoenzymeQ10
First Posted:
Mar 9, 2022
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zala Jenko Praznikar, Associate Professor, PhD, University of Primorska
coenzyme Q10
single dose bioavailability

Study Results

No Results Posted as of Jul 21, 2022