- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805697
Fermented Grape Combined With Fruits and Vegetables Drink on Anti-aging and Anti-inflammatory
March 17, 2021 updated by: TCI Co., Ltd.
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.
60 subjects were recruited and divided into placebo group and fermented grape drinks group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 100225
- Research & Design Center, TCI CO., Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Dry skin.
- Rough skin
- Large pores
- Dark yellow complexion
- Sagging skin
Exclusion Criteria:
- Skin disorders
- Liver diseases
- Kidney diseases
- Allergy to cosmetics, drugs, or foods
- Pregnant and lactating women
- People who had any cosmetic procedures before 4 weeks of the study
- Area of facial spot over 3 cm2
- Vegan
- People who took collagen supplements in the past 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo group
subjects drank 50 ml , 1 bottle a day for 8 week
|
subjects drank 50 ml , 1 bottle a day for 8 week
|
|
Experimental: fermented grape drinks
subjects drank 50 ml , 1 bottle a day for 8 week
|
subjects drank 50 ml , 1 bottle a day for 8 week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
skin brightness
Time Frame: 8 week
|
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
|
|
skin elasticity
Time Frame: 8 week
|
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
|
|
skin moisture
Time Frame: 8 week
|
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
|
|
skin spot
Time Frame: 8 week
|
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
|
|
skin wrinkle
Time Frame: 8 week
|
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
|
|
inflammatory cytokines
Time Frame: 8 week
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chia-Hua Liang, Ph.D, Chia Nan University of Pharmacy & Science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
August 31, 2020
Study Completion (Actual)
October 31, 2020
Study Registration Dates
First Submitted
March 16, 2021
First Submitted That Met QC Criteria
March 16, 2021
First Posted (Actual)
March 18, 2021
Study Record Updates
Last Update Posted (Actual)
March 22, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-054-B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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