Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT07198503
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Carotenoid-Based Instrumental Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Carotenoid Index', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': "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."}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': "BMI is derived from the subjects' measured height and weight."}, {'measure': 'Body Fat Percentage (BF%)', 'timeFrame': 'At a single Day 1 visit after enrollment'}, {'measure': 'Demographic Information', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': 'Including basic information such as gender, age, smoking status, use of health products or nutritional supplements, exercise habits.'}, {'measure': 'Dietary Intake', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': "Subjects' dietary intake during the previous month was evaluated using Food Frequency Questionnaire - 25 (FFQ-25)."}, {'measure': 'Fitzpatrick Skin Type', 'timeFrame': 'At a single Day 1 visit after enrollment'}, {'measure': 'Skin Condition Self-Assessment', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': '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.'}, {'measure': 'The score of 36-Item Short Form Survey (SF-36)', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': '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.'}, {'measure': 'Frequency of Physical Illness Symptoms', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': "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."}, {'measure': 'Gastrointestinal Discomfort Symptoms', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': "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."}, {'measure': 'Population-Based Visual Fatigue Scale Score', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': "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."}, {'measure': 'Traditional Chinese Medicine (TCM) Constitution Classification', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': "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."}, {'measure': 'Brief Resilience Scale (BRS) Score', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': '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.'}, {'measure': 'Multifactorial Memory Questionnaire (MMQ) Score', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': '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.'}, {'measure': 'Facial image analysis', 'timeFrame': 'At a single Day 1 visit after enrollment', 'description': 'Including red area ratio, number and area ratio of color spots, L, a, b, and ITA °.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Carotenoid Status']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese individuals of Asian ethnicity aged 18 years or above.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chinese individuals of Asian ethnicity aged 18 years or older.\n2. Basic proficiency in reading and writing Chinese, sufficient to independently complete questionnaires.\n3. Voluntary participation with signed informed consent.\n4. Willingness to comply with all assessment requirements.\n\nExclusion Criteria:\n\n1. Presence of open facial lesions, prominent scars, or visible acne marks.\n2. Currently planning pregnancy, pregnant, or breastfeeding.\n3. Ongoing treatment for acute or severe medical conditions.\n4. Significant impairments affecting cognitive or behavioral abilities.\n5. Other medical reasons identified by experts or professionals that may interfere with the assessment results.'}, 'identificationModule': {'nctId': 'NCT07198503', 'briefTitle': 'Study on Carotenoid-Based Instrumental Index', 'organization': {'class': 'INDUSTRY', 'fullName': 'ChinaNorm'}, 'officialTitle': 'Study on Carotenoid-Based Instrumental Index', 'orgStudyIdInfo': {'id': 'W25002001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chinese citizens aged 18-50', 'description': 'The study sample was selected to be as evenly distributed as possible in terms of age and gender.'}, {'label': 'Chinese citizens aged ≥50', 'description': 'The study sample was selected to be as evenly distributed as possible in terms of age and gender.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sunny Sun', 'role': 'CONTACT', 'email': 'sunnysun@china-norm.com', 'phone': '+86 18918961656'}], 'facility': 'Shanghai China-norm Quality Technical Service Co., Ltd.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ChinaNorm', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Nu Skin Enterprises', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}