Study With Two Coenzyme Q10 Products

NCT ID: NCT06736366

Last Updated: 2025-12-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-05

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products will include 35 subjects who will test two different coenzyme Q10 products. Plasma concentration of coenzyme Q10 will be measured.

Conditions

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Coenzyme Q Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Coenzyme Q10 (ubiquinone)

Synonyms: Maltodextrin, capsule (HPMC - hydroxypropyl methyl cellulose), coenzyme Q10 (ubiquinone); Dosage: 2 capsules, total 100 mg Co-Q10

Group Type ACTIVE_COMPARATOR

Dietary supplement - Experimental product

Intervention Type DIETARY_SUPPLEMENT

Single dose intervention with Experimental product; BMT® coenzyme Q10; 2 capsules - 100 mg total coenzyme Q10

BMT® coenzyme Q10

Maltodextrin, BMT® coenzyme Q10 \[maltodextrin, coenzyme Q10 (ubiquinone), stabiliser (gum arabic), corn starch, olive oil, anti-caking agent (silicon dioxide), acidity regulators (acetic acid, citric acid)\], capsule (HPMC - hydroxypropyl methyl cellulose); Dosage: 2 capsules, total 100 mg Co-Q10

Group Type EXPERIMENTAL

Dietary supplement - Active comparator

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Dietary supplement - Experimental product

Single dose intervention with Experimental product; BMT® coenzyme Q10; 2 capsules - 100 mg total coenzyme Q10

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement - Active comparator

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* subject informed consent form
* aged between 50 and 65 years old
* body mass for women 70± 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

Exclusion Criteria

* cardio-vascular diseases, diabetes, neurodegenerative diseases, gastrointestinal disorders, pregnancy, breast-feeding
* intake of any food supplements within two week of the beginning of the study
* drug or alcohol abuse
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biostile d.o.o.

UNKNOWN

Sponsor Role collaborator

QFarm s.r.l.

UNKNOWN

Sponsor Role collaborator

University of Primorska

OTHER

Sponsor Role lead

Responsible Party

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Zala Jenko Praznikar

Associate Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana Petelin, phD

Role: PRINCIPAL_INVESTIGATOR

University of Primorska, Faculty of Health Sciences

Locations

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University of Primorska, Faculty of Health Sciences

Izola, Izola, Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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Q10_2024

Identifier Type: -

Identifier Source: org_study_id

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