The Single-centre, Randomized, Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Serum coenzyme Q10 concentrations
研究概览
简要总结
The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Dietary supplement - standard product (Dietary Supplement)
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
干预措施: Dietary supplement - Investigational product IP1 (Dietary Supplement)
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
干预措施: Dietary supplement - Investigational product IP2 (Dietary Supplement)
结局指标
主要结局
Serum coenzyme Q10 concentrations
时间窗: 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
次要结局
未报告次要终点
研究者
Zala Jenko Praznikar
Associate Professor, PhD
University of Primorska