The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters: Randomised Double-blind Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
研究概览
简要总结
Placebo controlled double-blind multi-dose comparative study of the effects of coenzyme Q10 and collagen formulation with improved water-solubility in healthy adults.
One group (test group) will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg) and the other (placebo group) placebo syrup without those active ingredients. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects on skin condition and signs of skin aging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Caucasian female volunteers aged between 40 and 65 years at the time of the signature of Informed consent form (ICF),
- •Signed Informed consent form (ICF),
- •Fitzpatrick skin phototypes II and III,
- •Signs of skin aging,
- •In good health condition,
- •Willingness to avoid a consumption of any food supplements containing CoQ10 and other antioxidants, collagen or vitamins during the study,
- •Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability).
排除标准
- •Pregnancy or breastfeeding,
- •Known or suspected allergy to any ingredient of the tested products,
- •Changes in dietary habits and dietary supplementation in last three months prior to inclusion,
- •Regular use of food supplements containing CoQ10 or other antioxidants, collagen or other protein-based food supplements, vitamin A, vitamin E or biotin in last three months prior to inclusion,
- •Veganism,
- •Changes in cosmetic facial and body care routine in last month prior to inclusion,
- •Diagnosed and uncontrolled/untreated/unregulated disease,
- •Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological disease,
- •Acute skin diseases,
- •Skin pigmentation disorders,
- •Increased cholesterol and use of cholesterol lowering drugs (statins),
- •Anticipated sunbathing or solarium visits before or during the study,
- •Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels etc.) in last 6 months prior to study entry,
- •Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound therapy) in last 2 months prior to study entry,
- •Mental incapacity that precludes adequate understanding or cooperation.
结局指标
主要结局
Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
时间窗: 12 weeks
Significant change of dermis density from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement.
次要结局
- Influence of the investigational product in relation to placebo product on TEWL(12 weeks)
- Influence of investigational product in relation to placebo product on wrinkles will be assessed using wrinkle area fraction measurements(12 weeks)
- Influence of investigational product in relation to placebo product on dermis thickness(12 weeks)
- Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity(12 weeks)
- Influence of the investigational product in relation to placebo product on skin hydration(12 weeks)