Study on Carotenoid-Based Instrumental Index

NCT07198503 | Recruiting

• 1 other identifier: W25002001
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Carotenoid Status

Outcome Measures

Primary Outcomes (15)

• Skin Carotenoid Index

  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.

  At a single Day 1 visit after enrollment

• Body Mass Index (BMI)

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

  At a single Day 1 visit after enrollment

• Body Fat Percentage (BF%)

  At a single Day 1 visit after enrollment

• Demographic Information

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

  At a single Day 1 visit after enrollment

• Dietary Intake

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

  At a single Day 1 visit after enrollment

• Fitzpatrick Skin Type

  At a single Day 1 visit after enrollment

• Skin Condition Self-Assessment

  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.

  At a single Day 1 visit after enrollment

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

  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.

  At a single Day 1 visit after enrollment

• Frequency of Physical Illness Symptoms

  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.

  At a single Day 1 visit after enrollment

• Gastrointestinal Discomfort Symptoms

  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.

  At a single Day 1 visit after enrollment

• Population-Based Visual Fatigue Scale Score

  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.

  At a single Day 1 visit after enrollment

• Traditional Chinese Medicine (TCM) Constitution Classification

  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.

  At a single Day 1 visit after enrollment

• Brief Resilience Scale (BRS) Score

  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.

  At a single Day 1 visit after enrollment

• Multifactorial Memory Questionnaire (MMQ) Score

  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.

  At a single Day 1 visit after enrollment

• Facial image analysis

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

  At a single Day 1 visit after enrollment

Study Arms (2)

Chinese citizens aged 18-50

The study sample was selected to be as evenly distributed as possible in terms of age and gender.

Chinese citizens aged ≥50

The study sample was selected to be as evenly distributed as possible in terms of age and gender.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese individuals of Asian ethnicity aged 18 years or above.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ChinaNorm: lead
• Nu Skin Enterprises: collaborator

Study Sites (1)

Shanghai China-norm Quality Technical Service Co., Ltd.

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 30, 2025
• Study Start: September 6, 2025
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

CN (1)