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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sensitivity of skin to UV radiation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 67 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 20.0-29.9
- •Fitzpatrick skin type 2 and 3.
排除标准
- •pregnancy
- •breast-feeding
- •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
结局指标
主要结局
Sensitivity of skin to UV radiation
时间窗: 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.
次要结局
- skin transepidermal water loss(Baseline, 28 days)
- Skin net elasticity, viscoelasticity, and biological elasticity(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)
- Skin smoothness, scaliness, and roughness(Baseline, 28 days)