Study Summary
This trial will study the effects of dealcoholized muscadine wine on oxidative stress, inflammation, skin photoaging, and the gut microbiome in women.
Eligible Conditions
- Skin Health
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 0 Secondary · Reporting Duration: Baseline, 28 days
Baseline, 28 days
Change from baseline Skin color after UV radiation
Change from baseline skin erythema and melanin index
Change from baseline skin hydration
Change from baseline skin pH
Change from baseline skin transepidermal water loss
Change in Gut Microbiome
Trial Safety
Safety Progress
Trial Design
5 Treatment Groups
Muscadine Wine First
1 of 5
Sprite First
1 of 5
Control Beverage
1 of 5
Dealcoholized Muscadine Wine
1 of 5
Sugar Water
1 of 5
Active Control
20 Total Participants · 5 Treatment Groups
Primary Treatment: Muscadine Wine First · No Placebo Group · N/A
Muscadine Wine FirstActiveComparator Group · 2 Interventions: Sprite, Muscadine Wine · Intervention Types: Other, Other
Sprite FirstActiveComparator Group · 2 Interventions: Sprite, Muscadine Wine · Intervention Types: Other, Other
Control BeverageActiveComparator Group · 2 Interventions: Control Beverage, Dealcoholized Muscadine Wine · Intervention Types: Other, Other
Dealcoholized Muscadine WineActiveComparator Group · 3 Interventions: Control Beverage, Sugar Water, Dealcoholized Muscadine Wine · Intervention Types: Other, Other, Other
Sugar WaterActiveComparator Group · 2 Interventions: Sugar Water, Dealcoholized Muscadine Wine · Intervention Types: Other, Other
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 28 days
Who is running the clinical trial?
University of FloridaLead Sponsor
1,250 Previous Clinical Trials
698,733 Total Patients Enrolled
2 Trials studying Skin Health
42 Patients Enrolled for Skin Health
Liwei Gu, PhDPrincipal InvestigatorUniversity of Florida
6 Previous Clinical Trials
323 Total Patients Enrolled
1 Trials studying Skin Health
22 Patients Enrolled for Skin Health
Eligibility Criteria
Age 40 - 67 · Female Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Chen, Yashu, Qin Mu, Kai Hu, Mo Chen, Jifang Yang, Jigang Chen, Bijun Xie, and Zhida Sun. 2018. “Characterization of MK8(H2) from Rhodococcus Sp. B7740 and Its Potential Antiglycation Capacity Measurements”. Marine Drugs. MDPI AG. doi:10.3390/md16100391.
- Heinrich, Ulrike, Karin Neukam, Hagen Tronnier, Helmut Sies, and Wilhelm Stahl. 2006. “Long-term Ingestion of High Flavanol Cocoa Provides Photoprotection Against Uv-induced Erythema and Improves Skin Condition in Women”. The Journal of Nutrition. Oxford University Press (OUP). doi:10.1093/jn/136.6.1565.
- Heckman, Carolyn J., Rachel Chandler, Jacqueline D. Kloss, Amy Benson, Deborah Rooney, Teja Munshi, Susan D. Darlow, Clifford Perlis, Sharon L. Manne, and David W. Oslin. 2013. “Minimal Erythema Dose (MED) Testing”. Journal of Visualized Experiments. MyJove Corporation. doi:10.3791/50175.
- Heinrich, Ulrike, Carolyn E. Moore, Silke De Spirt, Hagen Tronnier, and Wilhelm Stahl. 2011. “Green Tea Polyphenols Provide Photoprotection, Increase Microcirculation, and Modulate Skin Properties of Women”. The Journal of Nutrition. Oxford University Press (OUP). doi:10.3945/jn.110.136465.
- Li, Ruiqi, Min-Hyun Kim, Amandeep K. Sandhu, Chi Gao, and Liwei Gu. 2017. “Muscadine Grape (vitis Rotundifolia) or Wine Phytochemicals Reduce Intestinal Inflammation in Mice with Dextran Sulfate Sodium-induced Colitis”. Journal of Agricultural and Food Chemistry. American Chemical Society (ACS). doi:10.1021/acs.jafc.6b03806.
- Micallef, Michelle, Louise Lexis, and Paul Lewandowski. 2007. “Red Wine Consumption Increases Antioxidant Status and Decreases Oxidative Stress in the Circulation of Both Young and Old Humans”. Nutrition Journal. Springer Science and Business Media LLC. doi:10.1186/1475-2891-6-27.
- 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.
- 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.
- 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.
- 2020. "Dealcoholized Muscadine Wine and Skin Health in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04614753.
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Conditions
Cancer Related
Treatments