Dietary Prevention of Photodamage in Skin With Grapes: A Human Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of subjects reporting protective effect against sunburn response to UVG and/or UVA1 following administration of dietary grape powder.
研究概览
简要总结
To assess the effect of orally administered grape powder on the sunburn reaction in humans.
详细描述
To determine whether oral grape powder will result in a reduction in biomarkers associated with basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs). Biomarkers taken from non-sun-exposed skin and UV-exposed skin before and after treatment will be compared.
The ultimate goal of this study will be to generate new knowledge of the photoprotective effect of grape powder on UV exposure. The results may be employed as the basis for a larger clinical trial to evaluate the potential of grapes to prevent non-melanoma skin cancers (NMSCs) and sun damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age 18 and older
- •Patient able to understand requirements of the study and risks involved
- •Patient able to sign a consent form
排除标准
- •Patients Fitzpatrick IV-VI
- •A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
- •A known history of photosensitivity disorders
- •A known history of melanoma or non-melanoma skin cancers
- •Those planning on going to the tanning parlors
- •Using any of the photosensitizing medication
- •A woman who is lactating, pregnant, or planning to become pregnant
- •Patient planning on exposing the irradiated or control areas to the sun
研究组 & 干预措施
Reconstituted grape powder
Open grape powder pouch and pour contents into volumetric measuring device. Add approximately 180 mL of water to container with grape powder. Stir for a minimum of 30 seconds and ingest.
干预措施: Reconstituted grape powder (Other)
结局指标
主要结局
Number of subjects reporting protective effect against sunburn response to UVG and/or UVA1 following administration of dietary grape powder.
时间窗: 2 weeks
Assessment will be quantified by evaluation of a person's minimal erythema dose (MED), the smallest amount of ultraviolet (UV) required to achieve a sunburn response. 6 small areas of skin (2 inches by 2 inches) on the inner part of a person's arm will be exposed to 6 separate but increasing doses of UV. 24 hours after UV treatment, the area that received the smallest dose of UV and has a visible area of redness will be marked and the respective UV dose will be considered the MED. A desirable outcome would be if an individual's MED goes up after 2 weeks of grape treatment.
次要结局
- Measure whether dietary grape powder results in a significant (p<0.05 using parire ttest) % change in markers associated with NMSC as measured by it biomarker: proliferating cell nuclear antigen (PCNA)(2 weeks)
- Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Ki67(2 weeks)
- Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Cyclin D1(2 weeks)
- Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Cyclooxygenase-2 (COX-2)(2 weeks)
- Measure whether dietary grape powder results in a significant (p<0.05 using parire ttest) % change in markers associated with NMSC as measured by it biomarker: ornithine decarboxylase (ODC)(2 weeks)
- Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: matrix metalloproteinase-7 (MMP-7)(2 weeks)
- Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: matrix metalloproteinase-9 (MMP-9)(2 weeks)
- Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Normal p53(2 weeks)
- Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Mutant p53(2 weeks)
- Determine whether dietary grape powder has photoprotective activities over a period of 2 weeks and resulting in a significant change in biomarkers associated with NMSC as measured by biomarker: Sunburnt cells(2 weeks)
- Determine whether dietary grape powder has photoprotective activities resulting in a significant change in biomarkers associated with NMSC: by biomarker: Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL)-positive cells(2 weeks)
研究者
Craig Elmets
Principal Investigator
University of Alabama at Birmingham