The goal of this clinical trial is to learn whether daily intake of CyanthOx™80 capsules can improve skin, scalp, hair, and selected blood biomarkers in healthy adults after 12 weeks. Researchers will compare participants who take CyanthOx™80 with participants who take a placebo to evaluate its effectiveness and tolerability. A total of 40 participants will be randomly assigned to the CyanthOx™80 group or placebo group, with 20 participants in each group. Participants will not know which capsule they receive. Participants will: Take one capsule daily for 12 weeks. Attend study visits at baseline and weeks 4, 8, and 12. Undergo non-invasive facial skin assessments at baseline, week 4, and week 12. Undergo scalp and hair assessments at baseline and weeks 4, 8, and 12. Provide a 10 mL blood sample at baseline and week 12 for tests related to antioxidant capacity, inflammation, aging, collagen, and blood lipids. Complete questionnaires about skin condition and product satisfaction. Provide collected shed hair at weeks 4, 8, and 12. Have facial, scalp, and hair photographs taken. Identifiable areas will be masked before disclosure. Before each skin or scalp assessment, participants will cleanse the test area with water and rest at room temperature for 30 minutes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
40
Participants will take one placebo capsule daily for 12 weeks.
Participants will take one CyanthOx™80 capsule daily for 12 weeks.
Chia Nan University of Pharmacy & Science
Tainan, Taiwan, Taiwan
Product Tolerability
Product tolerability will be assessed by recording any adverse events reported by participants during the study. The number and percentage of participants experiencing one or more adverse events will be summarized for each group. unit: number and percentage of participants
Time frame: Baseline to Week 12
Participant-Reported Skin Condition and Product Satisfaction
Perceived skin condition and product satisfaction will be assessed using a study-specific questionnaire with a 5-point scale, ranging from 1 to 5. Higher scores indicate greater perceived improvement or satisfaction. The percentage of participants with a score of 3 or higher will be reported. Unit:score
Time frame: Baseline, Week 4, and Week 12
Change in Blood Biomarkers (TEAC)
Changes in biomarkers related to antioxidant capacity using TEAC ELISA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Hair and Scalp Condition (hair-root diameter)
Changes in hair-root diameter by using Mitutoyo, C/N293-100 Unit:percent change
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Hair and Scalp Condition (hair strength)
Changes in hair strength by using Hair Pull Test Unit:percent change
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Hair and Scalp Condition (hair elasticity)
Changes in hair elasticity measured using SHIMADZU EZ-SX Unit:percent change
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Hair and Scalp Condition (tensile strength)
Changes in tensile strength by using SHIMADZU EZ-SX Unit:percent change
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Hair and Scalp Condition (hair shedding)
Changes in hair shedding by collecting and counting hairs found in the shower drain unit:percent change
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Blood Biomarkers (SOD)
Changes in biomarkers related to antioxidant capacity measured using SOD ELISA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (GSH)
Changes in biomarkers related to antioxidant capacity using GSH ELISA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (TNF-alpha)
Changes in biomarkers related to inflammation measured using TNF-alpha ELISA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (Desmosine)
Changes in biomarkers related to aging measured using Desmosine ELISA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (AGE)
Changes in biomarkers related to aging measured using AGE ELISA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (HA)
Changes in biomarkers related to collagen metabolism measured using TEAC HA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (NAD/NADH)
Changes in biomarkers related to antioxidant capacity measured using NAD/NADH ELISA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (Collagen)
Changes in biomarkers related to collagen metabolism measured using Collagen ELISA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (Telomerase)
Changes in biomarkers related to aging, measured using Telomerase ELISA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (CHOL)
Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (TEAC)
Changes in biomarkers related to antioxidant capacity, inflammation, aging, collagen metabolism, and blood lipid metabolism measured using TEAC ELISA kits. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (TG)
Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (HDL)
Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change
Time frame: Baseline and Week 12
Change in Blood Biomarkers (LDL)
Changes in biomarkers related to blood lipid metabolism measured using automated clinical chemistry analyzer. Unit: percent change
Time frame: Baseline and Week 12
Facial Skin Analysis Parameters (skin spots)
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin spots. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Wrinkle)
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Wrinkle. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Texture)
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Texture. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Spot)
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Spot. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (UV Spot)
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure UV Spot. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Brown Spot)
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Brown Spot. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Red Area)
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure Red Area. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Collagen)
DermaLab® Series SkinLab Combo was utilized to measure collagen. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Brightness)
Chroma Meter MM500 was utilized to measure Brightness. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Erythema)
Chroma Meter MM500 was utilized to measure Erythema. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Melanin)
Soft Plus was utilized to measure Melanin. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Skin Hydration)
Corneometer CM825 was utilized to measure Skin Hydration. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Skin Elasticity)
Soft Plus was utilized to measure Skin Elasticity. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
Facial Skin Analysis Parameters (Transepidermal Water Loss)
Tewameter TM300 was utilized to measure Transepidermal Water Loss. Units: percetage change.
Time frame: Baseline, Week 4, and Week 12
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