Evaluation of Human Efficacy of SOD Like Super Drink

NCT06322589 | Completed

• 1 other identifier: CMUH112-REC3-175
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dermatology

Keywords

Skin analysis; Skin care products

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• the change of skin surface hydration

  Change from Baseline skin surface hydration at 8 week

• the change of skin Transepidermal Water Loss (TEWL)

  Change from Baseline TEWL at 8 week

• the change of Skin Melanin Index

  Change from Baseline skin Melanin Index at 8 week

• the change of Skin Erythema Index

  Change from Baseline skin Erythema Index at 8 week

Other Outcomes (3)

• The change of liver function biomarkers (AST, ALT) of blood

  Change from Baseline liver function biomarkers at 8 weeks

• The change of renal function biomarkers (creatinine, BUN) of blood

  Change from Baseline renal function biomarkers at 8 weeks

• The change of self-assessment skin condition and immuno condition

  Change from Baseline skin condition and immunol condition at 8 weeks

Study Arms (2)

placebo drink

PLACEBO COMPARATOR

Dietary Supplement: placebo drink

SOD like Super Drink

EXPERIMENTAL

Dietary Supplement: SOD like Super Drink

Interventions

SOD like Super Drink DIETARY_SUPPLEMENT

consume 1 bottle per day

Also known as: AVON SOD like Super Drink

SOD like Super Drink

placebo drink DIETARY_SUPPLEMENT

consume 1 bottle per day

placebo drink

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adults aged between 30-65 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

China Medical University of department of cosmeceutics

Taichung, 406040, Taiwan

Location

Study Officials

• Hsiu-Mei Chiang

  China Medical University of department of cosmeceutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 21, 2024
• Study Start: March 1, 2024
• Primary Completion: May 15, 2024
• Study Completion: June 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

TW (1)