Evaluation of Human Efficacy of SOD Like Super Drink

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

Study Overview

• Status: Recruiting
• Conditions: Dermatology
• Intervention / Treatment: Dietary supplement: placebo drink; Dietary supplement: SOD like Super Drink

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ping Lin; Phone Number: +886-02-879778111; Email: candice.lin@tci-bio.com
• Study Contact Backup: Name: Hsiu-Mei Chiang; Phone Number: 5302 +886-04-22053366; Email: hmchiang@mail.cmu.edu.tw

Study Locations

• Taiwan
  • Taichung City, Taiwan, 406040
    • Recruiting
    • China Medical University of department of cosmeceutics
    • Contact: Ping Lin; Phone Number: +886-02-879778111; Email: candice.lin@tci-bio.com
    • Contact: Hsiu-Mei Chiang, Ph.D.; Phone Number: 5302 +886-04-22053366; Email: hmchiang@mail.cmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo drink	Dietary supplement: placebo drink; consume 1 bottle per day
Experimental: SOD like Super Drink	Dietary supplement: SOD like Super Drink; consume 1 bottle per day; Other Names: AVON SOD like Super Drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the volume of skin wrinkles	IRV full-face skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units	Volume change from Baseline skin wrinkles at 8 weeks
the roughness of skin texture	IRV full-face skin analyzer was utilized to measure skin texture. Units: arbitrary units	Rating skin roughness from Baseline skin texture at 8 weeks
the change of skin elasticity	Cutometer® was utilized to measure skin elasticity. Units: arbitrary units	Change from Baseline skin elasticity at 8 weeks
the change of Total Anti-oxidative Capacity (TAC) of blood	venous blood was sampled to measure TAC	Change from Baseline TAC at 8 weeks
the change of Superoxide Dismutase (SOD) of blood	venous blood was sampled to measure SOD	Change from Baseline SOD at 8 weeks
the change of Glutathione S-transferase (GST) of blood	venous blood was sampled to measure GST	Change from Baseline GST at 8 weeks
the change of Glutathione (GSH) of blood	venous blood was sampled to measure GSH	Change from Baseline GSH at 8 weeks
the change of Malondialdehyde (MDA) of blood	venous blood was sampled to measure MDA	Change from Baseline MDA at 8 weeks
the change of immune-related cytokines of blood	venous blood was sampled to measure immune-related cytokines	Change from Baseline immune-related cytokines at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of skin surface hydration	Corneometer® CM 825 was utilized to measure skin surface hydration. Units: arbitrary units	Change from Baseline skin surface hydration at 8 week
the change of skin Transepidermal Water Loss (TEWL)	Tewameter® TM 300 was utilized to measure TEWL. Units: arbitrary units	Change from Baseline TEWL at 8 week
the change of Skin Melanin Index	Mexameter® MX 18was utilized to measure Melanin Index. Units: arbitrary units	Change from Baseline skin Melanin Index at 8 week
the change of Skin Erythema Index	Mexameter® MX 18was utilized to measure skin Erythema Index. Units: arbitrary units	Change from Baseline skin Erythema Index at 8 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of liver function biomarkers (AST, ALT) of blood	Venous blood was sampled to measure liver function biomarkers	Change from Baseline liver function biomarkers at 8 weeks
The change of renal function biomarkers (creatinine, BUN) of blood	Venous blood was sampled to measure renal function biomarkers	Change from Baseline renal function biomarkers at 8 weeks
The change of self-assessment skin condition and immuno condition	A self-assessment questionnaire was collected to evaluate skin condition and immunol condition，As for the evalutation of skin condition ,the higher score the better；As for evaluation of immunol condition , the higher score the worse	Change from Baseline skin condition and immunol condition at 8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Hsiu-Mei Chiang, China Medical University of department of cosmeceutics

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Skin analysis; Skin care products
• Other Study ID Numbers: CMUH112-REC3-175

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No