The Impact of 12 Week Retention of Nutrients on Skin and the Perception of Physical Health Status
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Facial Image Capture VISIA-7
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled clinical trial exploring the effects of a 12-week dietary supplement regimen on skin condition and perceived overall health status.
The study will involve 120 healthy Chinese adults aged 18 and above with low daily fruit and vegetable intake. Participants will be randomly assigned to one of two groups: one group will take a combination of Nu Skin's Vitamin C & Green Tea Capsules and Multivitamin & Mineral Capsules, while the other group will take a matching placebo.
The primary goal is to assess if the supplement combination improves skin health after 12 weeks, measured through specialized facial imaging (assessing spots, redness, evenness) and probe measurements (assessing elasticity, moisture, gloss). Secondary goals include evaluating changes in participants' self-perceived health status (via quality of life, fatigue, and digestive health questionnaires), psychological resilience, memory, and exploring a new method for measuring skin carotenoid levels.
This study is not intended to verify the approved health functions of the products but to explore the potential combined effects of antioxidant and nutritional supplementation on skin and general well-being.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese adults of Asian descent aged 18 and above;
- •Daily fruit and vegetable intake < 240g (calculated based on the fruit and vegetable section of the food frequency questionnaire);
- •S3 measurement index < 30000;
- •Participants must possess basic Chinese reading comprehension and expression skills, and be able to independently complete questionnaire surveys;
- •Voluntary participation in the test and signing of the informed consent form;
- •Willingness to comply with all evaluation requirements.
排除标准
- •Presence of open facial skin lesions, clearly visible scars, acne marks, etc.;
- •Skin lesions, scars, or significant pigmentation on the hand measurement area;
- •Symptoms of skin disease on the face or hand measurement areas;
- •Having undergone medical aesthetic procedures within the last 6 months;
- •Participation in other clinical trials involving product use within the last 3 months;
- •Use of health supplements or nutritional supplements (e.g., vitamins, minerals) within the last 1 month;
- •Currently planning for pregnancy, pregnant, or lactating;
- •Presence of any disease under current treatment;
- •Any other health issues or chronic diseases that affect behavioral or cognitive abilities;
- •Other iatrogenic reasons identified by experts or professionals that may affect the evaluation results.
- •The S3 instrument refers to a Raman spectroscopy-based biophotonic scanner. The threshold for the S3 screening value is based on previously published literature, which indicated that participants with a daily fruit and vegetable intake of less than 240g had an average Raman spectroscopy biophotonic scanner score below 25,
- •However, considering practical recruitment challenges, the inclusion criterion was set at < 30,
- •The S3 device measures the Skin Carotenoid Index, a non-invasive biomarker reflecting skin carotenoid levels.
研究组 & 干预措施
Supplement Combination Group
干预措施: Vitamin C & Green Tea Capsules + Multivitamin & Mineral Capsules Combination (Dietary Supplement)
Placebo Control Group
干预措施: Placebo Combination (Matching) (Dietary Supplement)
结局指标
主要结局
Facial Image Capture VISIA-7
时间窗: Imaging sessions are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks)
Skin Elasticity Test Probe Cutometer
时间窗: Measurements are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks)
Skin Gloss Measurement Glossmeter
时间窗: Measurements are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).
Skin Moisture Content Corneometer
时间窗: Measurements are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks)
Skin Hemoglobin Measurement Mexameter MX18 (Courage & Khazaka, Germany)
时间窗: Measurements are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).
Skin Moisture Loss Meter Vapometer (Delfin, Finland)
时间窗: Measurements are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).
Skin Carotenoid Index
时间窗: Measurements are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).
次要结局
- Skin Condition Survey(The scales and questionnaires are administered at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).)
- Physical Health and Life Status Survey(The survey is administered at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).)
- Psychological State and Memory Level(The assessment is conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).)
- Self-Evaluation Questionnaire(This questionnaire is administered only at follow-up visits: T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).)
- Height and Weight Measurement BMI(Measurements are conducted at T0 (baseline, upon enrollment) and T12w (12 weeks).)