A Clinical Study to Evaluate the Efficacy of Nutritional Supplements on Human Health and to Assess the Reliability of Sponsor's Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Skin carotenoid score via Prysm iO device
研究概览
简要总结
The goal of this clinical trial is to evaluate a nutritional supplement in an otherwise healthy adult population. The main questions it aims to answer are:
- Do antioxidant carotenoid levels increase in after supplementation as measured by a non-invasive device?
- Do wellness factors correlate with supplementation?
Researchers will compare the nutritional supplement arm to a placebo group to assess its effects.
Participants will take either the nutritional supplement or placebo once daily for 8 weeks. Participants will be scanned by a non-invasive hyperspectral absorption device to obtain a skin carotenoid score. Participants will also have facial images taken, dermal spectrophotometry measurements of their face, and complete self-assessment questionnaires.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 20-60 years.
- •all skin types
- •BMI between 18.5-23
- •No allergy with carotenoid-containing supplements
排除标准
- •subject who have undergone organ excision, organ transplantation, or experienced a skull concussion with extended loss of consciousness in the past 5 years, or with current after effects.
- •subjects with diseases such as heart disease, myocardial infarction, cancer, tuberculosis, chronic or acute renal failure, poliomyelitis, arthritis, or asthma
- •Subjects undergoing or schedule for long-term treatment, particularly with anti-inflammatory agents, steroids, sedatives, diabetes treatments, medications for blood pressure, hormone therapies, antihistamines, and/or drugs with similar functions,
- •subjects who have taken contraceptives or herbal medicines continuously for more than 2 months within the past 3 weeks,
- •subjects with any current medical condition, including gynecological disorders, or those undergoing hospital treatment,
- •subjects with known allergies to aspirin, antibiotics, fruits, laboratory substances, sunlight or metals;
- •Subjects who experience herpes outbreaks more than five times a year or suffer from acute swelling of the skin or mucous membranes;
- •Subjects with a history of psychiatric disorders, including sleep disorders or panic disorder
研究组 & 干预措施
Active
LifePak Optimum nutritional supplement
干预措施: LifePak Optimum nutritional supplement (Dietary Supplement)
Placebo
Placebo supplement
干预措施: Placebo supplement (Dietary Supplement)
结局指标
主要结局
Skin carotenoid score via Prysm iO device
时间窗: 8 weeks
The Prysm iO device will provide a numerical score between 0-1000. The score is an indicator of skin carotenoid concentration/nutritional wellness. The higher the score the more positive the outcome.
Short-Form 36 Health Survey
时间窗: 8 weeks
The Short-Form 36 Health Survey is a validated questionnaire that measures multidimensional health-related quality of life, including specific domains of everyday life. The questionnaire has a 1-5 scale, with the higher score reflected a better perception of health-related outcomes.
Skin color measurement via Spectrophotometer
时间窗: 8 weeks
Perceived Immunity
时间窗: 8 weeks
Perceived Immunity Scale, a validated questionnaire to assess individuals' beliefs about the strength of their immune system. The assessment uses a 1-6 point Likert scale, where a lower score indicates greater disagreement with the statement, and a higher score indicates greater agreement with the statement.
Psychological Scales Related to Physical Condition
时间窗: 8 weeks
Short Health Anxiety Inventory (SHAI) a validated questionnaires using a 1-5 point Likert scale, (where a lower score indicates greater disagreement, and higher score indicates greater agreement) to assess feelings about health and recovery.
Fatigue and Vitality Status Assessment
时间窗: 8 weeks
Multi-Dimensional Fatigue Inventory--a validated questionnaire using a 1-7 Likert scale (where a lower score indicates greater disagreement, and a higher score indicates greater agreement) to assess an individual's fatigue state.
Brief Resilience Scale (BRS)
时间窗: 8 weeks
The Brief Resilience Scale (BRS) is a validated questionnaire, using a 1-5 point Likert scale (where a lower score indicates greater disagreement, and a higher score indicates greater agreement), to assess the ability to bounce back from feelings of stress.
次要结局
未报告次要终点