Study With Two Coenzyme Q10 Products (Co10_2024)

University of Primorska

Status: Completed

Conditions: Coenzyme Q Deficiency

Treatments: Dietary Supplement: Dietary supplement - Experimental product; Dietary Supplement: Dietary supplement - Active comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT06736366

Q10_2024

Details and patient eligibility

About

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

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Coenzyme Q10 (ubiquinone)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Dietary supplement - Experimental product

BMT® coenzyme Q10

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary supplement - Active comparator