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

• ClinicalTrials.gov Identifier: NCT04805697
• Recruitment Status: Completed
• First Posted: March 18, 2021
• Last Update Posted: March 22, 2021
• Sponsor: TCI Co., Ltd.
• Information provided by (Responsible Party): TCI Co., Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Skin Condition	Dietary Supplement: placebo group; Dietary Supplement: fermented grape drinks	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: October 1, 2019
• Actual Primary Completion Date: August 31, 2020
• Actual Study Completion Date: October 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: placebo group; subjects drank 50 ml , 1 bottle a day for 8 week	Dietary Supplement: placebo group; 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	Dietary Supplement: fermented grape drinks; subjects drank 50 ml , 1 bottle a day for 8 week

Outcome Measures

Primary Outcome Measures :

1. 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 )
2. 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)
3. 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)
4. 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)
5. 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)
6. 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)

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Taiwan

Research & Design Center, TCI CO., Ltd

Taipei, Taiwan, 100225

Sponsors and Collaborators

TCI Co., Ltd.

Investigators

• Study Director: Chia-Hua Liang, Ph.D; Chia Nan University of Pharmacy ＆ Science

More Information

• Responsible Party: TCI Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04805697
• Other Study ID Numbers: 20-054-B
• First Posted: March 18, 2021
• Last Update Posted: March 22, 2021
• Last Verified: March 2021

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

Additional relevant MeSH terms:

Skin Diseases; Disease; Pathologic Processes