Skin Health Clinical Trial
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
Verified date | September 2023 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | July 2, 2024 |
Est. primary completion date | July 2, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 67 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Food Science and Human Nutrition Department at University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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. — View Citation
Heckman 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. — View Citation
Heinrich 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. — View Citation
Heinrich 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. — View Citation
Li 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. — View Citation
Micallef 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Change from baseline skin pH | Skin pH will be measured using a Skin-pH-Meter (CK Electronic GmbH, Germany). | Baseline, 28 days | |
Primary | 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 | |
Primary | Change from baseline skin hydration | Skin hydration will be measured with a Corneometer (CK Electronic GmbH, Germany). | Baseline, 28 days |
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