Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
NCT ID: NCT05272228
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2022-03-09
2022-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
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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 - standard product
Single dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10
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 - Investigational product IP1
Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10
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 - Investigational product IP2
Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10
Interventions
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Dietary supplement - standard product
Single dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10
Dietary supplement - Investigational product IP1
Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10
Dietary supplement - Investigational product IP2
Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
55 Years
ALL
Yes
Sponsors
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Biovis d.o.o.
UNKNOWN
University of Primorska
OTHER
Responsible Party
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Zala Jenko Praznikar
Associate Professor, PhD
Principal Investigators
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Zala Jenko-Pražnikar, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Primorska, Faculty of Health Sciences
Locations
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University of Primorska
Izola, , Slovenia
Countries
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Other Identifiers
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CoenzymeQ10
Identifier Type: -
Identifier Source: org_study_id
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