Efficacy Evaluation of Pitaya Ovule Extract on Skin

NCT05311020 | Completed

• 1 other identifier: CMUH111-REC3-028-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy of Pitaya Ovule Extract on skin

Conditions

Skin Condition

Outcome Measures

Primary Outcomes (10)

• The change of L* (lightness) values

  Spectrophotometer SCM-108 was utilized to measure skin L\* value. Units: arbitrary units

  Change from Baseline L* value at 8 weeks

• The change of skin elasticity

  Cutometer® Dual MPA580 was utilized to measure skin elasticity. Units: arbitrary units

  Change from Baseline skin elasticity at 8 weeks

• The change of skin collagen density

  DermaLab® Combo Ultrasound module was utilized to measure skin collagen density. Units: arbitrary units

  Change from Baseline skin collagen density at 8 weeks

• The change of skin wrinkles

  IRV skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units

  Change from Baseline skin wrinkles at 8 weeks

• The change of skin texture

  IRV skin analyzer was utilized to measure skin texture. Units: arbitrary units

  Change from Baseline skin texture at 8 weeks

• The change of skin pores

  IRV skin analyzer was utilized to measure skin pores. Units: arbitrary units

  Change from Baseline skin pores at 8 weeks

• The change of skin tone

  IRV skin analyzer was utilized to measure skin tone. Units: arbitrary units

  Change from Baseline skin tone at 8 weeks

• The change of Advanced glycation end products of blood

  Venous blood was sampled to measure AGEs

  Change from Baseline AGEs at 8 weeks

• The change of RAGE (receptor for advanced glycation end products) of blood

  Venous blood was sampled to measure RAGE

  Change from Baseline RAGE at 8 weeks

• The change of Matrix metalloproteinases (MMP-2, MMP-9) of blood

  Venous blood was sampled to measure MMPs

  Change from Baseline MMPs at 8 weeks

Secondary Outcomes (5)

• 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 fasting blood glucose level

  Change from Baseline fasting blood glucose level at 8 weeks

• Change from Baseline insulin level at 8 weeks

  Change from Baseline insulin level at 8 weeks

• The change of blood lipid profile

  Change from Baseline blood lipid profile at 8 weeks

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR

Dietary Supplement: Placebo drink

Pitaya Ovule Extract Drink

EXPERIMENTAL

Dietary Supplement: Pitaya Ovule Extract Drink

Interventions

Placebo drink DIETARY_SUPPLEMENT

consume 1 bottle per day

Placebo drink

Pitaya Ovule Extract Drink DIETARY_SUPPLEMENT

consume 1 bottle per day

Pitaya Ovule Extract Drink

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65-year-old males or females

You may not qualify if:

• Received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial
• Outdoor workers (exposed to the sun more than 5 hours a day)
• People who are breastfeeding, pregnant or planning to become pregnant during the test (self-report)
• People with heart, liver, kidney, endocrine and other major organic diseases (self-reported)
• People who have undergone major surgery (according to medical history)
• People who take drugs for a long time
• People with mental illness
• 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

Taichung, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Hsiu-Mei Chiang, Prof.

  China Medical University, China

  PRINCIPAL INVESTIGATOR

• Po-Yuan Wu, Dr.

  China Medical University Hospital

  STUDY DIRECTOR

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: March 28, 2022
• First Posted: April 5, 2022
• Study Start: October 19, 2022
• Primary Completion: December 23, 2022
• Study Completion: January 16, 2023
• Last Updated: February 9, 2023

Record last verified: 2022-09

Locations

TW (1)