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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05311020
Other study ID # CMUH111-REC3-028-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2022
Est. completion date January 16, 2023

Study information

Verified date September 2022
Source TCI Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the efficacy of Pitaya Ovule Extract on skin


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 16, 2023
Est. primary completion date December 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - 20 to 65-year-old males or females Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo drink
consume 1 bottle per day
Pitaya Ovule Extract Drink
consume 1 bottle per day

Locations

Country Name City State
Taiwan China Medical University Taichung

Sponsors (1)

Lead Sponsor Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary The change of Advanced glycation end products of blood Venous blood was sampled to measure AGEs Change from Baseline AGEs at 8 weeks
Primary 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
Primary 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 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
Secondary 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
Secondary The change of fasting blood glucose level Venous blood was sampled to measure fasting blood glucose level Change from Baseline fasting blood glucose level at 8 weeks
Secondary Change from Baseline insulin level at 8 weeks Venous blood was sampled to measure insulin level Change from Baseline insulin level at 8 weeks
Secondary The change of blood lipid profile Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride) Change from Baseline blood lipid profile at 8 weeks
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