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Dealcoholized Muscadine Wine and Skin Health in Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04614753
Enrollment
20
Registered
2020-11-04
Start date
2020-10-10
Completion date
2024-10-07
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Health

Brief 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. 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.

Interventions

OTHERDealcoholized Muscadine Wine

300 ml of Dealcoholized Muscadine Wine

300ml of Sugar Water and Acid Content

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 67 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of skin to UV radiationBaseline, 28 daysIrradiation 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.

Secondary

MeasureTime frameDescription
Change in Gut MicrobiomeBaseline, 28 daysFecal 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.
skin hydrationBaseline, 28 daysSkin hydration will be measured with a Corneometer (CK Electronic GmbH, Germany).
skin erythema and melanin indexBaseline, 28 daysSkin 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.
skin transepidermal water lossBaseline, 28 daysSkin 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)
Skin smoothness, scaliness, and roughnessBaseline, 28 daysSkin will be scanned using a probe.
Skin net elasticity, viscoelasticity, and biological elasticityBaseline, 28 daysSkin will be measured using a probe.
skin pHBaseline, 28 daysSkin pH will be measured using a Skin-pH-Meter (CK Electronic GmbH, Germany).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026