Clinical trial NCT04614753: Dealcoholized Muscadine Wine and Skin Health in Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Health
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of skin to UV radiation
timeFrame: Baseline, 28 days
Secondary outcomes:
measure: skin transepidermal water loss
timeFrame: Baseline, 28 days
measure: Change in Gut Microbiome
timeFrame: Baseline, 28 days
measure: skin hydration
timeFrame: Baseline, 28 days
measure: skin erythema and melanin index
timeFrame: Baseline, 28 days
measure: skin pH
timeFrame: Baseline, 28 days
measure: Skin smoothness, scaliness, and roughness
timeFrame: Baseline, 28 days
measure: Skin net elasticity, viscoelasticity, and biological elasticity
timeFrame: Baseline, 28 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Food Science and Human Nutrition Department at University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Liwei Gu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.