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临床试验/NCT07198503
NCT07198503招募中不适用

Study on Carotenoid-Based Instrumental Index

ChinaNorm1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年9月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
The score of 36-Item Short Form Survey (SF-36)

研究概览

简要总结

Nu Skin (China) Daily-Use&Health Products Co.,Ltd. has developed biophotonic scanners based on Raman spectroscopy, which measures skin carotenoid levels through hand skin scanning. In this study, the new Prysm device, which adopts new technology in a lower cost and more portable form, was used to measure skin carotenoid levels in a population, and the relationships between these levels and dietary habits and lifestyle factors were analyzed. The collected data included basic demographic information such as age, gender, smoking status, use of health products or nutritional supplements, and exercise habits, as well as physiological indicators such as BMI and body fat percentage. Subjective assessments were also obtained, including questionnaires on diet, skin condition, physical health, lifestyle, psychological status, and memory performance, alongside skin image analyses capturing parameters such as ITA°, L*, a*, b*, glossiness, erythema, and pigmentation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chinese individuals of Asian ethnicity aged 18 years or older.
  • Basic proficiency in reading and writing Chinese, sufficient to independently complete questionnaires.
  • Voluntary participation with signed informed consent.
  • Willingness to comply with all assessment requirements.

排除标准

  • Presence of open facial lesions, prominent scars, or visible acne marks.
  • Currently planning pregnancy, pregnant, or breastfeeding.
  • Ongoing treatment for acute or severe medical conditions.
  • Significant impairments affecting cognitive or behavioral abilities.
  • Other medical reasons identified by experts or professionals that may interfere with the assessment results.

结局指标

主要结局

The score of 36-Item Short Form Survey (SF-36)

时间窗: At a single Day 1 visit after enrollment

It consists of 9 different dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), Mental Health (MH), Reported Health Transition (HT). Each dimension is scored from 0 to 100, higher scores reflect better health, functionality, and quality of life.

Frequency of Physical Illness Symptoms

时间窗: At a single Day 1 visit after enrollment

Subjects' immune function over the past year was evaluated using a questionnaire that collected the frequency of symptoms, including colds, influenza, allergies, etc. The total score ranges from 0 to 28, higher scores are associated with poorer immune function.

Gastrointestinal Discomfort Symptoms

时间窗: At a single Day 1 visit after enrollment

Subjects' gastrointestinal discomfort over the past month, including symptoms such as abdominal pain and bloating, was assessed using a questionnaire. The total score ranges from 20 to 100, and higher scores reflect more severe symptoms of gastrointestinal discomfort.

Traditional Chinese Medicine (TCM) Constitution Classification

时间窗: At a single Day 1 visit after enrollment

Subjects' body constitution was evaluated and categorized based on the Traditional Chinese Medicine Constitution Classification and Determination Self-Assessment Form, following the standards of the China Association of Chinese Medicine. For each constitution classification, scores range from 0 to 100, and higher scores indicate greater alignment with specific body constitution.

Brief Resilience Scale (BRS) Score

时间窗: At a single Day 1 visit after enrollment

The BRS score is calculated by summing averaging the scores of all the six items, which ranges from 1 to 5. A higher average indicates greater psychological resilience, while a lower average indicates lower psychological resilience.

Multifactorial Memory Questionnaire (MMQ) Score

时间窗: At a single Day 1 visit after enrollment

It consists of three subscales: How I Feel About My Memory (scores range from 0 to 72), Memory Mistakes (scores range from 0 to 80) and Use of Memory Strategies (scores range from 0 to 68). A higher score indicates better memory.

Facial image analysis

时间窗: At a single Day 1 visit after enrollment

Including red area ratio, number and area ratio of color spots, L, a, b, and ITA °.

Skin Carotenoid Index

时间窗: At a single Day 1 visit after enrollment

The Prysm device utilizing hyperspectral absorption technology and the S3 device utilizing Raman spectroscopy technology, was used to measure the skin carotenoid index on subjects' fingers.

Population-Based Visual Fatigue Scale Score

时间窗: At a single Day 1 visit after enrollment

The questionnaire comprises 5 ocular symptoms (such as 'discomfort around the eyes', 'dryness of the eyes', etc.) and 6 visual and systemic symptoms (such as 'eye discomfort caused by screen brightness', 'anxiety associated with eye discomfort', etc.). The total score ranges from 0 to 44, higher scores reflect greater symptom severity.

Body Mass Index (BMI)

时间窗: At a single Day 1 visit after enrollment

BMI is derived from the subjects' measured height and weight.

Fitzpatrick Skin Type

时间窗: At a single Day 1 visit after enrollment

Dietary Intake

时间窗: At a single Day 1 visit after enrollment

Subjects' dietary intake during the previous month was evaluated using Food Frequency Questionnaire - 25 (FFQ-25).

Body Fat Percentage (BF%)

时间窗: At a single Day 1 visit after enrollment

Demographic Information

时间窗: At a single Day 1 visit after enrollment

Including basic information such as gender, age, smoking status, use of health products or nutritional supplements, exercise habits.

Skin Condition Self-Assessment

时间窗: At a single Day 1 visit after enrollment

Subjects evaluated their skin condition during the previous month using a self-assessment questionnaire, covering dimensions such as photodamage, skin brightness, skin radiance, etc. Each dimension is scored from 0 to 9, with higher scores indicating better skin condition.

次要结局

未报告次要终点

研究者

发起方
ChinaNorm
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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