The Effect of 12-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters: Double Blind, Placebo-controlled, Randomised Four-way Study Comparing the Efficacy of Three Test Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Change of dermis density from baseline in all test groups in comparison to placebo group after 12 weeks of dietary supplementation
研究概览
简要总结
The aim of the randomized, double-blind, placebo-controlled, one-period effectiveness study is to compare the effects of multiple-dose 12 weeks daily dietary supplementation with 10 g collagen alone or 5 g or 10 g of collagen in combination with MSM on skin in healthy human subjects in comparison to placebo product. The main objective is to show that test products have beneficial effects on dermis density, and also on other skin parameters and to investigate differences in the effects among test products.
详细描述
This is a double-blind, randomized, placebo-controlled four-way study comparing the efficacy of multiple-dose dietary intake of three test products on skin parameters, that will be conducted in Slovenia in one research center.
The study will be performed on 109 adult women, between the ages 40 and 65 years and will include daily dietary supplementation over 12-weeks period.
Subjects will be divided in four study groups . Test group 1 (TG1) will receive investigational product 1 (IP1, daily dose 25 mL: collagen 5 g, MSM: 1,5 g, vitamin C: 80 mg), test group 2 (TG2) will receive investigational product 2 (IP2, daily dose 25 mL: collagen 10 g, vitamin C: 80 mg), test group 3 (TG3) will receive investigational product 3 (TP3, daily dose 25 mL: collagen 10 g, MSM: 1,5 g, , vitamin C: 80 mg) and the placebo group (PG) will receive placebo product without those active ingredients (25 mL: 0 g collagen, 0 g MSM). Participants will test continuous administration of placebo or investigational products for 12 weeks in order to demonstrate and assess multiple-dose effects. Their influence on skin appendages via self-evaluations questionnaires will also be assessed.
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 I-IV,
- •Signs of skin aging,
- •In good general health condition,
- •Body mass index (BMI) < 35
- •Willingness to avoid a consumption of any food supplements containing methylsulfonylmethane (MSM), antioxidants, collagen and other protein-based food supplements during the study,
- •Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability).
- •Willingness to maintain their living habits and to not begin or change any estrogen or progesterone therapies,
- •Willingness to avoid shaving/depilation of their arms during the study,
- •Willingness not to change cosmetic treatment routine during the study,
- •Willingness to avoid rejuvenation treatments during the study.
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 the last three months prior to inclusion,
- •Regular use of food supplements containing MSM, antioxidants, collagen or other protein-based food supplements in the last three months prior to inclusion,
- •Veganism,
- •Changes in cosmetic facial and body care routine in the last month prior to inclusion,
- •Diagnosed and uncontrolled/unregulated disease,
- •Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, hematological disease,
- •Intake of drugs with any impact on skin reactions (e.g., glucocorticoids, antihistamines, and immunomodulators),
- •Any clinically significant acute or chronic skin diseases,
- •Skin pigmentation disorders on measuring sites,
- •Anticipated sunbathing or solarium visits before or during the study,
- •Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels, laser therapy etc.) in the last 4 months prior to study entry,
- •Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound, intense pulsed light therapy (IPL)) in the last month prior to study entry,
- •Shaving/depilation of the arms in the last 14 days before inclusion,
- •Mental incapacity that precludes adequate understanding or cooperation.
结局指标
主要结局
Change of dermis density from baseline in all test groups in comparison to placebo group after 12 weeks of dietary supplementation
时间窗: 12 weeks
Significant change of dermis density from baseline in test groups, 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. Differences in change of dermis density between test groups under primary objective conditions will also be evaluated.
次要结局
- Change of skin texture from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)
- Change of skin hydration from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)
- Change of dermis thickness from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)
- Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)
- Change of TEWL from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)
- Change of skin elasticity from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)