Clinical trial NCT06322589: Evaluation of Human Efficacy of SOD Like Super Drink
Official title: Evaluation of Human Efficacy of SOD Like Super Drink
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatology
Keywords: Skin analysis
Skin care products
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the efficacy of SOD like Super Drink on anti-oxidant capacity, immuno regulation and skin for human


Eligibility criteria: Inclusion Criteria:

* healthy adults aged between 30-65 years old

Exclusion Criteria:

* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder
* Patients with diseases of the skin, liver, kidney.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 4 weeks.
* Students who are currently taking courses taught by the principal investigator of this trial.

Primary outcomes:
measure: the volume of skin wrinkles
timeFrame: Volume change from Baseline skin wrinkles at 8 weeks
measure: the roughness of skin texture
timeFrame: Rating skin roughness from Baseline skin texture at 8 weeks
measure: the change of skin elasticity
timeFrame: Change from Baseline skin elasticity at 8 weeks
measure: the change of Total Anti-oxidative Capacity (TAC) of blood
timeFrame: Change from Baseline TAC at 8 weeks
measure: the change of Superoxide Dismutase (SOD) of blood
timeFrame: Change from Baseline SOD at 8 weeks
measure: the change of Glutathione S-transferase (GST) of blood
timeFrame: Change from Baseline GST at 8 weeks
measure: the change of Glutathione (GSH) of blood
timeFrame: Change from Baseline GSH at 8 weeks
measure: the change of Malondialdehyde (MDA) of blood
timeFrame: Change from Baseline MDA at 8 weeks
measure: the change of immune-related cytokines of blood
timeFrame: Change from Baseline immune-related cytokines at 8 weeks
Secondary outcomes:
measure: the change of skin surface hydration
timeFrame: Change from Baseline skin surface hydration at 8 week
measure: the change of skin Transepidermal Water Loss (TEWL)
timeFrame: Change from Baseline TEWL at 8 week
measure: the change of Skin Melanin Index
timeFrame: Change from Baseline skin Melanin Index at 8 week
measure: the change of Skin Erythema Index
timeFrame: Change from Baseline skin Erythema Index at 8 week
Other outcomes:
measure: The change of liver function biomarkers (AST, ALT) of blood
timeFrame: Change from Baseline liver function biomarkers at 8 weeks
measure: The change of renal function biomarkers (creatinine, BUN) of blood
timeFrame: Change from Baseline renal function biomarkers at 8 weeks
measure: The change of self-assessment skin condition and immuno condition
timeFrame: Change from Baseline skin condition and immunol condition at 8 weeks
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University of department of cosmeceutics
Study officials:
affiliation: China Medical University of department of cosmeceutics
name: Hsiu-Mei Chiang
role: PRINCIPAL_INVESTIGATOR
References: