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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2020
CompletedFirst Submitted
Initial submission to the registry
October 20, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2024
CompletedJune 12, 2025
October 1, 2024
4 years
October 20, 2020
June 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 28 days
Secondary Outcomes (7)
skin transepidermal water loss
Baseline, 28 days
Change in Gut Microbiome
Baseline, 28 days
skin hydration
Baseline, 28 days
skin erythema and melanin index
Baseline, 28 days
skin pH
Baseline, 28 days
- +2 more secondary outcomes
Study Arms (2)
Dealcoholized Muscadine Wine
ACTIVE COMPARATORParticipants 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 COMPARATORParticipants 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.
Interventions
300 ml of Dealcoholized Muscadine Wine
300ml of Sugar Water and Acid Content
Eligibility Criteria
You may qualify if:
- Healthy,
- BMI 20.0-29.9
- Fitzpatrick skin type 2 and 3.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Food Science and Human Nutrition Department at University of Florida
Gainesville, Florida, 32611, United States
Related Publications (6)
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.
PMID: 30340371BACKGROUNDLi 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.
PMID: 28112913BACKGROUNDMicallef 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.
PMID: 17888186BACKGROUNDHeinrich 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.
PMID: 21525260BACKGROUNDHeinrich 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.
PMID: 16702322BACKGROUNDHeckman 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.
PMID: 23748556BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Liwei Gu, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2020
First Posted
November 4, 2020
Study Start
October 10, 2020
Primary Completion
October 7, 2024
Study Completion
October 7, 2024
Last Updated
June 12, 2025
Record last verified: 2024-10