Dealcoholized Muscadine Wine and Skin Health in Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Skin Health

Intervention / Treatment
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* Other: Dealcoholized Muscadine Wine
* Other: Control Beverage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, BMI 20.0-29.9 Fitzpatrick skin type 2 and 3. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dealcoholized Muscadine Wine<br>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 | Other: Dealcoholized Muscadine Wine<br>* 300 ml of Dealcoholized Muscadine Wine<br>Other: Control Beverage<br>* 300ml of Sugar Water and Acid Content<br>|
| Active Comparator: Control Beverage<br>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. | Other: Dealcoholized Muscadine Wine<br>* 300 ml of Dealcoholized Muscadine Wine<br>Other: Control Beverage<br>* 300ml of Sugar Water and Acid Content<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Skin color after 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 using the 3-dimensional color system with L-, a-, and b-values. L- and b- values assess lightness and browning effects, respectively. The a-value (red/green-axis) is a measure for reddening (erythema). | Baseline, 28 days | 
| Change from baseline 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) | 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. | Baseline, 28 days | 
| Change from baseline skin pH | Skin pH will be measured using a Skin-pH-Meter (CK Electronic GmbH, Germany). | Baseline, 28 days | 
| Change from baseline 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. | Baseline, 28 days | 
| Change from baseline skin hydration | Skin hydration will be measured with a Corneometer (CK Electronic GmbH, Germany). | Baseline, 28 days |