BECOME Study: Comparative Efficacy of Bovine and Marine Collagen Versus Placebo on Skin, Hair, Nails and Whole Body Health Markers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in skin elasticity
研究概览
简要总结
The BECOME Study (Bovine and Marine Collagen Efficacy for Skin, Hair, Nails and Whole Body Health Markers Evaluation) is a randomized controlled trial designed to compare the effects of bovine and marine collagen supplements versus a placebo on skin, hair, nails and whole body health markers. The trial aims to determine the most efficacious collagen source for improving health outcomes and to establish if both types of collagen are equally effective. Participants will be assessed on various health parameters, including skin elasticity, joint health, digestive health, and overall well-being, over a specified period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 35-55 years. Participants must be comfortable with bovine or marine collagen (non-vegan/vegetarian).
- •Must provide informed consent and be willing to comply with study requirements.
排除标准
- •Pregnant or breastfeeding women. History of chronic skin conditions (e.g., eczema, psoriasis) that might interfere with study outcomes.
- •Any active skin infections or severe acne. Currently taking collagen supplements or have taken them within the last 6 months.
- •Use of medications or topical agents that can affect skin, hair, nails, or gastrointestinal health (e.g., corticosteroids, retinoids).
- •Excessive alcohol consumption or current smokers. Regular use of sunbeds. Recent cosmetic procedures (e.g., Botox, fillers, chemical peels, laser treatments) on skin, hair, or nails within the last 3 months.
- •Any condition or situation that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study requirements or give informed consent.
- •Poor adherence to previous study protocols
结局指标
主要结局
Change in skin elasticity
时间窗: Baseline, week 6 and week 12
Changes in skin elasticity will be measured by a cutometer
Change in nail strength and growth
时间窗: Baseline, week 6 and week 12
Assessment of nail strength and growth will be assessed by self-perception questionnaire
Change in hair thickness and strength
时间窗: Baseline, week 6 and week 12
Strength and breakage of hair will be assessed by self perception questionnaire
Change in skin wrinkles
时间窗: Baseline, week 6 and week 12
Measurement of the reduction in skin wrinkles using Profilometer
Change in perceived skin health
时间窗: Baseline, week 6 and week 12
Changes in perceived skin health assessed by self perception questionnaire
Change in skin wrinkles by visual assessment
时间窗: Baseline, week 6 and week 12
Change in skin wrinkles will be performed by visual assessment by a dermatologist
Changes in skin pigmentation
时间窗: Baseline, week 6 and week 12
Changes in skin pigmentation will be assessed by Chromameter
Changes in skin hydration
时间窗: Baseline, week 6 and week 12
Changes in skin hydration will be assessed by a Corneometer
次要结局
- Digestive Quality of Life (DQDL) Assessment(Baseline, week 6 and week 12)
- Subjective Perception Questionnaire(Baseline, week 6 and week 12)