Skin ConditionNCT04805697
Fermented Grape Combined With Fruits and Vegetables Drink on Anti-aging and Anti-inflammatory
A study testing fermented grape drinks in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
60 subjects were recruited and divided into placebo group and fermented grape drinks group. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Condition
- What is being tested?
- fermented grape drinks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2019to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dry skin.
- Rough skin
- Large pores
- Dark yellow complexion
- Sagging skin
Who cannot join
- 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
Show all 9Show fewer
- Area of facial spot over 3 cm2
- Vegan
- People who took collagen supplements in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
60 subjects were recruited and divided into placebo group and fermented grape drinks group.
Read the 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.
- Conditions
- Skin Condition
- Being tested
- placebo group, fermented grape drinks
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo groupDietary supplement
subjects drank 50 ml , 1 bottle a day for 8 week
fermented grape drinksDietary supplement
subjects drank 50 ml , 1 bottle a day for 8 week
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | subjects drank 50 ml , 1 bottle a day for 8 week Receives: Dietary Supplement: placebo group |
| fermented grape drinks | Experimental | subjects drank 50 ml , 1 bottle a day for 8 week Receives: Dietary Supplement: fermented grape drinks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Oct 2019
- Primary completion31 Aug 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Hua Liang, Ph.D, Study director, Chia Nan University of Pharmacy ＆ Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805697
- Sponsor's protocol ID
- 20-054-B
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04805697
- Acronym / sponsor ID
- 20-054-B
- Conditions
- Skin Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Dietary Supplement: placebo groupsubjects drank 50 ml , 1 bottle a day for 8 week |
| fermented grape drinks | Experimental | Dietary Supplement: fermented grape drinkssubjects drank 50 ml , 1 bottle a day for 8 week |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dry skin.
- Rough skin
- Large pores
- Dark yellow complexion
- Sagging skin
Key exclusion criteria (9 listed)
- Skin disorders
- Liver diseases
- Kidney diseases
- Allergy to cosmetics, drugs, or foods
- Pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo groupsubjects drank 50 ml , 1 bottle a day for 8 week | Dietary supplement | placebo group |
| fermented grape drinkssubjects drank 50 ml , 1 bottle a day for 8 week | Dietary supplement | fermented grape drinks |
Primary outcome
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 )
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hua Liang, Ph.D study director
Chia Nan University of Pharmacy ＆ Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fermented grape drinks in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin brightness (time frame: 8 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.