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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04805697
Other study ID # 20-054-B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date October 31, 2020

Study information

Verified date March 2021
Source TCI Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

60 subjects were recruited and divided into placebo group and fermented grape drinks group.


Description:

In this study, using a fermented grape drinks made of fermented grapes with fruit and vegetable powder to explore whether it can improve the skin's condition and achieve anti-inflammatory effects. Sixty subjects were recruited and divided into placebo group and fermented grape drinks group. After drinking for 8 weeks, skin test and blood biochemical analysis were performed.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: 1. Dry skin. 2. Rough skin 3. Large pores 4. Dark yellow complexion 5. Sagging skin Exclusion Criteria: 1. Skin disorders 2. Liver diseases 3. Kidney diseases 4. Allergy to cosmetics, drugs, or foods 5. Pregnant and lactating women 6. People who had any cosmetic procedures before 4 weeks of the study 7. Area of facial spot over 3 cm2 8. Vegan 9. People who took collagen supplements in the past 3 months.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
placebo group
subjects drank 50 ml , 1 bottle a day for 8 week
fermented grape drinks
subjects drank 50 ml , 1 bottle a day for 8 week

Locations

Country Name City State
Taiwan Research & Design Center, TCI CO., Ltd Taipei

Sponsors (1)

Lead Sponsor Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary skin brightness The subjects divided into a placebo group (n=30) and an experimental group (n=30). Each subject was informed to consume one bottle of a 50 mL of grape drink or a placebo drink daily for 8 weeks, then using corneometer CM825 to examine skin brightness (The higher the value, the more water content, C.U., corneometer units ) 8 week
Primary skin elasticity The subjects divided into a placebo group (n=30) and an experimental group (n=30). Each subject was informed to consume one bottle of a 50 mL of grape drink or a placebo drink daily for 8 weeks, then using cutometer dual MPA580 to examine skin elasticity (The closer the R2 value is to 1, the better the elasticity and no unit) 8 week
Primary skin moisture The subjects divided into a placebo group (n=30) and an experimental group (n=30). Each subject was informed to consume one bottle of a 50 mL of grape drink or a placebo drink daily for 8 weeks, then using probe system GL2000 & MPA10 to examine skin moisture (The higher the value, the higher the gloss, no unit) 8 week
Primary skin spot The subjects divided into a placebo group (n=30) and an experimental group (n=30). Each subject was informed to consume one bottle of a 50 mL of grape drink or a placebo drink daily for 8 weeks, then usig VISIA-CR to examine skin spot (The higher the value, the larger the pore area, mm2) 8 week
Primary skin wrinkle The subjects divided into a placebo group (n=30) and an experimental group (n=30). Each subject was informed to consume one bottle of a 50 mL of grape drink or a placebo drink daily for 8 weeks, then using VISIOSCAN-VC20 to examine skin wrinkle (The higher the value, the more wrinkles, surface evaluation of wrinkles, SEW) 8 week
Primary inflammatory cytokines The subjects divided into a placebo group (n=30) and an experimental group (n=30). Each subject was informed to consume one bottle of a 50 mL of grape drink or a placebo drink daily for 8 weeks, then using ELISA kit to examine inflammatory cytokines (pg/ml) 8 week
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