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RecruitingNCT07198503Updated Sep 30, 2025

Study on Carotenoid-Based Instrumental Index

An observational study in Skin Carotenoid Status, sponsored by ChinaNorm. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by ChinaNorm · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Carotenoid Status
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Chinese individuals of Asian ethnicity aged 18 years or above.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Presence of open facial lesions, prominent scars, or visible acne marks.
  2. Currently planning pregnancy, pregnant, or breastfeeding.
  3. Ongoing treatment for acute or severe medical conditions.
  4. Significant impairments affecting cognitive or behavioral abilities.
  5. Other medical reasons identified by experts or professionals that may interfere with the assessment results.
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At a single Day 1 visit after enrollment

  2. Body Mass Index (BMI)

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

    Time frame: At a single Day 1 visit after enrollment

  3. Body Fat Percentage (BF%)

    Time frame: At a single Day 1 visit after enrollment

  4. Demographic Information

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

    Time frame: At a single Day 1 visit after enrollment

  5. Dietary Intake

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

    Time frame: At a single Day 1 visit after enrollment

  6. Fitzpatrick Skin Type

    Time frame: At a single Day 1 visit after enrollment

  7. 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.

    Time frame: At a single Day 1 visit after enrollment

  8. 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.

    Time frame: At a single Day 1 visit after enrollment

  9. 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.

    Time frame: At a single Day 1 visit after enrollment

  10. 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.

    Time frame: At a single Day 1 visit after enrollment

  11. 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.

    Time frame: At a single Day 1 visit after enrollment

  12. 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.

    Time frame: At a single Day 1 visit after enrollment

  13. 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.

    Time frame: At a single Day 1 visit after enrollment

  14. 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.

    Time frame: At a single Day 1 visit after enrollment

  15. Facial image analysis

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

    Time frame: At a single Day 1 visit after enrollment

06

Study locations

1 of 1 sites recruiting
  • Shanghai China-norm Quality Technical Service Co., Ltd.
    Shanghai, Shanghai Municipality 200072, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07198503
Lead sponsor
ChinaNorm
Collaborators
Nu Skin Enterprises
Responsible party
Sponsor
First posted
Sep 30, 2025
Start date
Sep 6, 2025
Primary completion
Oct 16, 2025 (estimated)
Completion
Oct 16, 2025 (estimated)
Last update
Sep 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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