Effect of Orally Delivered Phytochemicals, Alone, and in Combination, on Aging and Inflammation-Related Effects in the Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Erythema 2 Days After UV Exposure
研究概览
简要总结
The objective is to determine, in a small number of participants, the protective effects of UV-induced skin erythema (reddening or "sunburn") following oral administration of sulforaphane, curcumin, or a combination of the two plant (diet)-based supplements. The investigators will be using the over-the-counter nutritional supplements Crucera-SGS and Meriva-SF to deliver the biologically stable sulforaphane precursor and a highly bioavailable formulation of curcumin. Volunteers will be challenged with UV irradiation at 2-times the minimum erythematous dose (M.E.D.) on discrete 2 cm diameter circles on the upper buttocks. Skin redness will be monitored daily using a chromometer. Biomarkers will then be evaluated in blood, urine, and skin biopsies.
详细描述
Oral sulforaphane (SF) delivery results in systemic protection of a wide variety of organ systems which The investigators hypothesize will also include the skin, based on animal studies and preliminary evidence in human volunteers. Since The investigators have only previously evaluated the ability of topical sulforaphane application to protect skin from UV-induced erythema, the next logical step is to evaluate the ability of oral delivery to affect the skin of healthy human volunteers. Curcumin is also a potent anti-inflammatory that acts upon different biochemical pathways from SF, and it is an antioxidant. It was discovered over a century ago, it has been the subject of well over a hundred clinical studies, and it has been an ingredient in common foods eaten by millions of people, for centuries. Before and after consumption of each of these common food ingredients, The investigators will: (a) measure the Phase 2 cytoprotective response in human skin, (b) determine whether it leads to reduced UV-induced erythema (reduced inflammation), (c) evaluate changes in age-related markers such as dermal elasticity, keratin and collagen levels, (d) measure advanced glycation end-products (AGEs) in the serum, as biomarkers of systemic (including the skin) reduction in AGE levels, and (e) measure the levels of these biomarkers in skin punch biopsies. The investigators will also evaluate the effects of combined oral SF and curcumin. The investigators anticipate that there may be a true synergistic response between SF and curcumin, and the experiments designed herein are designed to show that synergy, if it exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-70 years old, healthy
- •Willingness to avoid sun exposure to study site
- •Willingness to adhere to cruciferous vegetable-free diet
排除标准
- •Use of photosensitizing medications
- •Use of medications that cause skin flushing
- •Use of anticoagulants/antiplatelet therapies
- •Allergies to anesthetic agents
- •Use of systemic retinoids or steroids (excluding female contraceptives and levothyroxin)
- •Topical retinoids or steroids at study sites
- •Antibiotic use
- •Current students of the Principal Investigator
- •Procedures performed at the study sites
- •Smokers/tobacco users
结局指标
主要结局
Change in Erythema 2 Days After UV Exposure
时间窗: On day 9 of intervention
Brief ultraviolet (UV) exposure on small circular spots on the skin will produce erythema (reddening), to be measured with a chromameter and photographed in the days following UV exposure, both before and after subjects have ingested study supplement (Crucera SGS, Meriva 500-SF, or both), daily, for a week. These measures will be compared to erythema in the skin of the same individuals following UV exposure, but WITHOUT having ingested these supplements.
Change in Erythema 3 Days After UV Exposure
时间窗: On day 10 of intervention
Brief ultraviolet (UV) exposure on small circular spots on the skin will produce erythema (reddening), to be measured with a chromameter and photographed in the days following UV exposure, both before and after subjects have ingested study supplement (Crucera SGS, Meriva 500-SF, or both), daily, for a week. These measures will be compared to erythema in the skin of the same individuals following UV exposure, but WITHOUT having ingested these supplements.
Change in Erythema 1 Day After UV Exposure
时间窗: On day 8 of intervention
Brief ultraviolet (UV) exposure on small circular spots on the skin will produce erythema (reddening), to be measured with a chromameter and photographed in the days following UV exposure, both before and after subjects have ingested study supplement (Crucera SGS, Meriva 500-SF, or both), daily, for a week. These measures will be compared to erythema in the skin of the same individuals following UV exposure, but WITHOUT having ingested these supplements.
次要结局
- Bioavailability of Supplement Metabolites in bodily fluids(Day 7 of each phase of intervention)
- Change in metabolomic profile(Day 7 of each phase of the intervention)
- Change in tissue-based RNA biomarkers of inflammation(Up to day 8 of intervention)
- Change in tissue-based protein biomarkers of inflammation(Up to day 10 of intervention)
- Change in urine-based biomarkers of inflammation(Day 7 of each phase of the intervention)
- Change in RNA markers of aging and protection from UV damage(Up to day 8 of intervention)
- Change in protein and small-molecule markers of aging and protection from UV damage(Up to day 10 of intervention)
- Change in blood-based biomarkers of inflammation(Day 7 of each phase of the intervention)