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NCT Number: NCT04614753

Dealcoholized Muscadine Wine and Skin Health in Women

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.

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Key information

Conditions

Skin Health

Age range

40 year–67 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Food Science and Human Nutrition Department at University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dealcoholized Muscadine Wine

Other

300 ml of Dealcoholized Muscadine Wine

Control Beverage

Other

300ml of Sugar Water and Acid Content

Primary outcomes

  1. 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.

Secondary outcomes

  1. skin transepidermal water loss

    Time frame: Baseline, 28 days

    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)

  2. Change in Gut Microbiome

    Time frame: Baseline, 28 days

    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.

  3. skin hydration

    Time frame: Baseline, 28 days

    Skin hydration will be measured with a Corneometer (CK Electronic GmbH, Germany).

  4. skin erythema and melanin index

    Time frame: Baseline, 28 days

    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.

  5. skin pH

    Time frame: Baseline, 28 days

    Skin pH will be measured using a Skin-pH-Meter (CK Electronic GmbH, Germany).

  6. Skin smoothness, scaliness, and roughness

    Time frame: Baseline, 28 days

    Skin will be scanned using a probe.

  7. Skin net elasticity, viscoelasticity, and biological elasticity

    Time frame: Baseline, 28 days

    Skin will be measured using a probe.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 4, 2020
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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