Evaluation of Human Efficacy of SOD Like Super Drink

NCT06322589 — Not applicable, Completed, 50 participants, TCI Co., Ltd.

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RegistryNCT06322589
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, other
Enrollment50 (Actual)
SponsorTCI Co., Ltd. (Industry)
ConditionsDermatology
InterventionsSOD like Super Drink, placebo drink (Dietary supplement)
Datesstart 2024-03-01, primary completion 2024-05-15, completion 2024-06-30, first posted 2024-03-21, last updated 2024-12-06
Locations1 site in Taiwan

Related Papers Related Patents Related Grants Related Experts
All trials for Dermatology All trials of SOD like Super Drink All trials of placebo drink

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
placebo drinkPlacebo comparatorDietary Supplement: placebo drink
SOD like Super DrinkExperimentalDietary Supplement: SOD like Super Drink
  • SOD like Super Drink (Dietary supplement), also known as AVON SOD like Super Drink: consume 1 bottle per day
  • placebo drink (Dietary supplement): consume 1 bottle per day

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

Other outcomes

  • The change of liver function biomarkers (AST, ALT) of blood [Change from Baseline liver function biomarkers at 8 weeks]: Venous blood was sampled to measure liver function biomarkers
  • The change of renal function biomarkers (creatinine, BUN) of blood [Change from Baseline renal function biomarkers at 8 weeks]: Venous blood was sampled to measure renal function biomarkers
  • The change of self-assessment skin condition and immuno condition [Change from Baseline skin condition and immunol condition at 8 weeks]: 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

+Eligibility

Sex: All, ages: 30 Years to 65 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
China Medical University of department of cosmeceuticsTaichungTaiwan

+Investigators

  • Hsiu-Mei Chiang, Principal investigator, China Medical University of department of cosmeceutics