Skin HealthNCT04614753
Dealcoholized Muscadine Wine and Skin Health in Women
A study testing Dealcoholized Muscadine Wine in people with Skin Health, run by University of Florida at 1 site in United States.
Trial summary
The objective of this clinical trial is to determine the activity of dealcoholized muscadine wine to alleviate oxidative stress, inflammation, skin photoaging, and alter gut microbiome in women 40-67 years of age. Read more about this study
- Who is it for?
- Ages 40 to 67 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Dealcoholized Muscadine Wine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2020to 7 Oct 2024
- 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 40 to 67 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy,
- BMI 20.0-29.9
- Fitzpatrick skin type 2 and 3.
Who cannot join
- pregnancy
- breast-feeding
- smoking
- alcohol use
- history of skin cancer
- intake of medication that might influence the outcome of the study
- sunbathing or the use of tanning bed
- intake of vitamin/mineral supplements
Trial locations and contacts
1 site in 1 country.
United States1 site
Food Science and Human Nutrition Department at University of Florida
Gainesville, Florida, 32611
About this study
Official title: A Clinical Trial to Determine the Activity of Dealcoholized Muscadine Wine to Alleviate Oxidative Stress, Inflammation, Skin Photoaging, and Alter the Gut Microbiome in Women 40-67
The objective of this clinical trial is to determine the activity of dealcoholized muscadine wine to alleviate oxidative stress, inflammation, skin photoaging, and alter gut microbiome in women 40-67 years of age. The investigators hypothesize that dealcoholized muscadine wine daily for 42 days will significantly alleviate oxidative stress, inflammation, skin photoaging, and alter the gut microbiome in women compared to drinking sugar water.
Read the detailed description
Aging of the skin is characterized by wrinkling, sagging, and laxity. About 80% of facial skin aging is classified as extrinsic, or photoaging because it results from exposure to UV light of the sun that causes oxidative stress The remaining 20% of facial aging is the intrinsic type which is partially caused by the accumulation of proteins that are modified by reactive carbonyls in a reaction known as protein glycation. Aging also shifts the composition of the gut microbiome in at least 35 genera towards an unhealthy state of dysbiosis.
Previous studies showed that muscadine polyphenols inhibited protein glycation under a simulated physiological condition. Additional experiments using cell culture and mice showed that dealcoholized muscadine wine alleviated inflammation and protected against dysbiosis in the gut. The objective of this research is to confirm the health benefits of muscadine wine polyphenols in a clinical trial. The investigators hypothesize that dealcoholized muscadine wine consumption in women 40-65 years old will alleviate skin photoaging and skin conditions by decreasing oxidative stress and inflammation. It is also expected to improve the composition of the gut microbiome.
- Conditions
- Skin Health
- Being tested
- Dealcoholized Muscadine Wine, Control Beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dealcoholized Muscadine WineOther
300 ml of Dealcoholized Muscadine Wine
Control BeverageOther
300ml of Sugar Water and Acid Content
| Study group | Role | What they receive |
|---|---|---|
| Dealcoholized Muscadine Wine | Active comparator | Participants in this arm will receive 300ml of dealcoholized muscadine wine daily for six weeks. After a 7- day run-in period, participants will receive dealcoholized muscadine wine daily for six weeks Receives: Other: Dealcoholized Muscadine Wine; Other: Control Beverage |
| Control Beverage | Active comparator | Participants in this arm will receive 300 ml of sugar water and acid content for six weeks. After a 7-day run in period, participants will receive sugar water for six weeks. Receives: Other: Dealcoholized Muscadine Wine; Other: Control Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of skin to UV radiation
Irradiation will be applied to dorsal skin (back, scapular region not typically exposed to the sun) with 2 times of minimal erythema dose using an FDA approved UVB phototherapy light and a UV light meter. At each time point on day 0 and 29, skin color will be measured before and 24 h after irradiation. Skin color will be evaluated by a colorimeter.
Measured: Baseline, 28 days
Secondary outcomes (7)
skin transepidermal water loss
Skin transepidermal water loss will be measured using a Tewameter (CK Electronic GmbH, Germany) to evaluate the water barrier function of the skin. The Tewameter measures the density gradient of the water evaporation from the skin (g/h/m^2)
Measured: Baseline, 28 days
Change in Gut Microbiome
Fecal samples will be collected and microbial DNA will be extracted from fecal samples . The 16S ribosomal gene (V1-3 region) of each sample will be amplified and sequenced using a barcoding system on a MiSeq sequencer.
Measured: Baseline, 28 days
skin hydration
Skin hydration will be measured with a Corneometer (CK Electronic GmbH, Germany).
Measured: Baseline, 28 days
skin erythema and melanin index
Skin erythema and melanin index will be assessed with Mexameter (CK Electronic GmbH, Germany). These two components are mainly responsible for the color of the skin. They are measured by reflectance.
Measured: Baseline, 28 days
skin pH
Skin pH will be measured using a Skin-pH-Meter (CK Electronic GmbH, Germany).
Measured: Baseline, 28 days
Skin smoothness, scaliness, and roughness
Skin will be scanned using a probe.
Measured: Baseline, 28 days
Skin net elasticity, viscoelasticity, and biological elasticity
Skin will be measured using a probe.
Measured: Baseline, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start10 Oct 2020
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liwei Gu, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614753
- Sponsor's protocol ID
- IRB202000789
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2020
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Y, Mu Q, Hu K, Chen M, Yang J, Chen J, Xie B, Sun Z. Characterization of MK(8)(H(2)) from Rhodococcus sp. B7740 and Its Potential Antiglycation Capacity Measurements. Mar Drugs. 2018 Oct 18;16(10):391. doi: 10.3390/md16100391.
PubMed 30340371Li R, Kim MH, Sandhu AK, Gao C, Gu L. Muscadine Grape (Vitis rotundifolia) or Wine Phytochemicals Reduce Intestinal Inflammation in Mice with Dextran Sulfate Sodium-Induced Colitis. J Agric Food Chem. 2017 Feb 1;65(4):769-776. doi: 10.1021/acs.jafc.6b03806. Epub 2017 Jan 23.
PubMed 28112913Micallef M, Lexis L, Lewandowski P. Red wine consumption increases antioxidant status and decreases oxidative stress in the circulation of both young and old humans. Nutr J. 2007 Sep 24;6:27. doi: 10.1186/1475-2891-6-27.
PubMed 17888186Heinrich U, Moore CE, De Spirt S, Tronnier H, Stahl W. Green tea polyphenols provide photoprotection, increase microcirculation, and modulate skin properties of women. J Nutr. 2011 Jun;141(6):1202-8. doi: 10.3945/jn.110.136465. Epub 2011 Apr 27.
PubMed 21525260Heinrich U, Neukam K, Tronnier H, Sies H, Stahl W. Long-term ingestion of high flavanol cocoa provides photoprotection against UV-induced erythema and improves skin condition in women. J Nutr. 2006 Jun;136(6):1565-9. doi: 10.1093/jn/136.6.1565.
PubMed 16702322Heckman CJ, Chandler R, Kloss JD, Benson A, Rooney D, Munshi T, Darlow SD, Perlis C, Manne SL, Oslin DW. Minimal Erythema Dose (MED) testing. J Vis Exp. 2013 May 28;(75):e50175. doi: 10.3791/50175.
PubMed 23748556
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Determine the Activity of Dealcoholized Muscadine Wine to Alleviate Oxidative Stress, Inflammation, Skin Photoaging, and Alter the Gut Microbiome in Women 40-67
- ClinicalTrials.gov ID
- NCT04614753
- Acronym / sponsor ID
- IRB202000789
- Conditions
- Skin Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 4 Nov 2020 (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.
The objective of this clinical trial is to determine the activity of dealcoholized muscadine wine to alleviate oxidative stress, inflammation, skin photoaging, and alter gut microbiome in women 40-67 years of age. The investigators hypothesize that dealcoholized muscadine wine daily for 42 days will significantly alleviate oxidative stress, inflammation, skin photoaging, and alter the gut microbiome in women compared to drinking sugar water.
Detailed description
Aging of the skin is characterized by wrinkling, sagging, and laxity. About 80% of facial skin aging is classified as extrinsic, or photoaging because it results from exposure to UV light of the sun that causes oxidative stress The remaining 20% of facial aging is the intrinsic type which is partially caused by the accumulation of proteins that are modified by reactive carbonyls in a reaction known as protein glycation. Aging also shifts the composition of the gut microbiome in at least 35 genera towards an unhealthy state of dysbiosis.
Previous studies showed that muscadine polyphenols inhibited protein glycation under a simulated physiological condition. Additional experiments using cell culture and mice showed that dealcoholized muscadine wine alleviated inflammation and protected against dysbiosis in the gut. The objective of this research is to confirm the health benefits of muscadine wine polyphenols in a clinical trial. The investigators hypothesize that dealcoholized muscadine wine consumption in women 40-65 years old will alleviate skin photoaging and skin conditions by decreasing oxidative stress and inflammation. It is also expected to improve the composition of the gut microbiome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dealcoholized Muscadine Wine | Active comparator | Other: Dealcoholized Muscadine Wine, Other: Control BeverageParticipants in this arm will receive 300ml of dealcoholized muscadine wine daily for six weeks. After a 7- day run-in period, participants will receive dealcoholized muscadine wine daily for six weeks |
| Control Beverage | Active comparator | Other: Dealcoholized Muscadine Wine, Other: Control BeverageParticipants in this arm will receive 300 ml of sugar water and acid content for six weeks. After a 7-day run in period, participants will receive sugar water for six weeks. |
Who may qualify
- Ages
- 40 to 67 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy,
- BMI 20.0-29.9
- Fitzpatrick skin type 2 and 3.
Key exclusion criteria (8 listed)
- pregnancy
- breast-feeding
- smoking
- alcohol use
- history of skin cancer
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 |
|---|---|---|
| Dealcoholized Muscadine Wine300 ml of Dealcoholized Muscadine Wine | Other | Control Beverage, Dealcoholized Muscadine Wine |
| Control Beverage300ml of Sugar Water and Acid Content | Other | Control Beverage, Dealcoholized Muscadine Wine |
Primary outcome
Sensitivity of skin to UV radiation
Time frame: Baseline, 28 days
Irradiation will be applied to dorsal skin (back, scapular region not typically exposed to the sun) with 2 times of minimal erythema dose using an FDA approved UVB phototherapy light and a UV light meter. At each time point on day 0 and 29, skin color will be measured before and 24 h after irradiation. Skin color will be evaluated by a colorimeter.
7 secondary outcomes
skin transepidermal water loss
Time frame: Baseline, 28 days
Change in Gut Microbiome
Time frame: Baseline, 28 days
skin hydration
Time frame: Baseline, 28 days
skin erythema and melanin index
Time frame: Baseline, 28 days
skin pH
Time frame: Baseline, 28 days
Skin smoothness, scaliness, and roughness
Time frame: Baseline, 28 days
Skin net elasticity, viscoelasticity, and biological elasticity
Time frame: Baseline, 28 days
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 12 Jun 2025.
- Background: PubMed 30340371Chen Y, Mu Q, Hu K, Chen M, Yang J, Chen J, Xie B, Sun Z. Characterization of MK(8)(H(2)) from Rhodococcus sp. B7740 and Its Potential Antiglycation Capacity Measurements. Mar Drugs. 2018 Oct 18;16(10):391. doi: 10.3390/md16100391.
- Background: PubMed 28112913Li R, Kim MH, Sandhu AK, Gao C, Gu L. Muscadine Grape (Vitis rotundifolia) or Wine Phytochemicals Reduce Intestinal Inflammation in Mice with Dextran Sulfate Sodium-Induced Colitis. J Agric Food Chem. 2017 Feb 1;65(4):769-776. doi: 10.1021/acs.jafc.6b03806. Epub 2017 Jan 23.
- Background: PubMed 17888186Micallef M, Lexis L, Lewandowski P. Red wine consumption increases antioxidant status and decreases oxidative stress in the circulation of both young and old humans. Nutr J. 2007 Sep 24;6:27. doi: 10.1186/1475-2891-6-27.
- Background: PubMed 21525260Heinrich U, Moore CE, De Spirt S, Tronnier H, Stahl W. Green tea polyphenols provide photoprotection, increase microcirculation, and modulate skin properties of women. J Nutr. 2011 Jun;141(6):1202-8. doi: 10.3945/jn.110.136465. Epub 2011 Apr 27.
- Background: PubMed 16702322Heinrich U, Neukam K, Tronnier H, Sies H, Stahl W. Long-term ingestion of high flavanol cocoa provides photoprotection against UV-induced erythema and improves skin condition in women. J Nutr. 2006 Jun;136(6):1565-9. doi: 10.1093/jn/136.6.1565.
- Background: PubMed 23748556Heckman CJ, Chandler R, Kloss JD, Benson A, Rooney D, Munshi T, Darlow SD, Perlis C, Manne SL, Oslin DW. Minimal Erythema Dose (MED) testing. J Vis Exp. 2013 May 28;(75):e50175. doi: 10.3791/50175.
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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.
Liwei Gu, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dealcoholized Muscadine Wine in people with Skin Health, run by University of Florida at 1 site in United States.
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 3 inclusion and 8 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 12 Jun 2025. 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 United States. 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. 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?
Sensitivity of skin to UV radiation (time frame: Baseline, 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614753, which also lists 6 linked publications.
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 12 Jun 2025.