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

Study Overview
=================
Brief Summary
-----------------
The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products

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.

Official Title
-----------------
The Single-centre, Randomized, Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products

Conditions
-----------------
Coenzyme Q Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Dietary supplement - standard product
* Dietary Supplement: Dietary supplement - Investigational product IP1
* Dietary Supplement: Dietary supplement - Investigational product IP2


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coenzyme Q10 (ubiquinone)<br>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<br>* Single dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10<br>|
| Experimental: Q10 MICROENCAPSULATED<br>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<br>* Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10<br>|
| Experimental: Final formulated product BQSM®<br>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<br>* Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coenzyme Q10, single dose bioavailability