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Fermented Grape Combined With Fruits and Vegetables Drink on Anti-aging and Anti-inflammatory

Primary Purpose

Skin Condition

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
placebo group
fermented grape drinks
Sponsored by
TCI Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Condition

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Research & Design Center, TCI CO., Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo group

fermented grape drinks

Arm Description

subjects drank 50 ml , 1 bottle a day for 8 week

subjects drank 50 ml , 1 bottle a day for 8 week

Outcomes

Primary Outcome Measures

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 )
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)
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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
March 16, 2021
Last Updated
March 17, 2021
Sponsor
TCI Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04805697
Brief Title
Fermented Grape Combined With Fruits and Vegetables Drink on Anti-aging and Anti-inflammatory
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
subjects drank 50 ml , 1 bottle a day for 8 week
Arm Title
fermented grape drinks
Arm Type
Experimental
Arm Description
subjects drank 50 ml , 1 bottle a day for 8 week
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo group
Intervention Description
subjects drank 50 ml , 1 bottle a day for 8 week
Intervention Type
Dietary Supplement
Intervention Name(s)
fermented grape drinks
Intervention Description
subjects drank 50 ml , 1 bottle a day for 8 week
Primary Outcome Measure Information:
Title
skin brightness
Description
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 )
Time Frame
8 week
Title
skin elasticity
Description
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)
Time Frame
8 week
Title
skin moisture
Description
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)
Time Frame
8 week
Title
skin spot
Description
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)
Time Frame
8 week
Title
skin wrinkle
Description
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)
Time Frame
8 week
Title
inflammatory cytokines
Description
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)
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang, Ph.D
Organizational Affiliation
Chia Nan University of Pharmacy ＆ Science
Official's Role
Study Director
Facility Information:
Facility Name
Research & Design Center, TCI CO., Ltd
City
Taipei
ZIP/Postal Code
100225
Country
Taiwan

12. IPD Sharing Statement

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Fermented Grape Combined With Fruits and Vegetables Drink on Anti-aging and Anti-inflammatory

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