NCT04805697

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

March 16, 2021

Last Update Submit

March 17, 2021

Conditions

Skin Condition

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: placebo group

fermented grape drinks

EXPERIMENTAL

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

Dietary Supplement: fermented grape drinks

Interventions

placebo groupDIETARY_SUPPLEMENT

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

placebo group
fermented grape drinksDIETARY_SUPPLEMENT

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

fermented grape drinks

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dry skin.
  • Rough skin
  • Large pores
  • Dark yellow complexion
  • Sagging skin

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research & Design Center, TCI CO., Ltd

Taipei, 100225, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Chia-Hua Liang, Ph.D

    Chia Nan University of Pharmacy ＆ Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 18, 2021

Study Start

October 1, 2019

Primary Completion

August 31, 2020

Study Completion

October 31, 2020

Last Updated

March 22, 2021

Record last verified: 2021-03

Locations

TW(1)