Clinical Trial to Determine the Efficacy of Pomegranate for Skin Inflammation and Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in inflammatory markers between pomegranate extract and pomegranate juice versus placebo.
研究概览
简要总结
The purpose of this study is to determine the efficacy of pomegranate extract and pomegranate juice on skin inflammation and aging. The information gained from this study may lead to the development of a pomegranate product that can decrease the effects of aging, inflammation and harmful bacteria on the skin.
In this study, two pomegranate products (extract and juice) will be compared with a placebo, a study product that looks like pomegranate extract, but contains no active ingredients.
详细描述
Pomegranate (Punica granatum L.) is grown commercially in the Near East, India, Spain, Israel and the United States (California) where it is of significant economic importance1. Pomegranate fruits and products, including juice, tea, wine and extracts are widely consumed and recognized for their health benefits. Pomegranate (Punica granatum L.) fruit possesses strong antioxidant, anti-inflammatory and antiproliferative properties. In recent years, most health advantages of pomegranate have been attributed to the presence of ellagitannins, mainly punicalagins and ellagic acid. Punicalagin is unique to pomegranate and is part of a family of ellagitannins. The ellagitannins are hydrolyzed to ellagic acid in the gut, and further metabolized by the colon microflora to form urolith A and B. Investigations using pure bacterial cultures have shown that pomegranate by-products and punicalagins significantly inhibited the growth of pathogenic Escherichia coli, Pseudomonas aeruginosa, clostridia and Staphylococcus aureus.
Oral feeding of pomegranate fruit extract to mice afforded protection to mouse skin against the adverse effects of ultraviolet-B (UVB) radiation by modulating UVB-induced signaling pathways.5 Hydroalcoholic extract based-ointment from pomegranate was reported improving wound healing in vivo. Pomegranate ellagitannins have been demonstrated to have antimicrobial activity. Punicalagin is unique to pomegranate and is part of a family of ellagitannins. The ellagitannins are hydrolyzed to ellagic acid in the gut, and further metabolized by the colon microflora to form urolith A and B. Investigations using pure bacterial cultures have shown that pomegranate by-products and punicalagins significantly inhibited the growth of pathogenic Escherichia coli, Pseudomonas aeruginosa, clostridia and Staphylococcus aureus.
Pomegranate Extract (POMx) is made from pomegranate fruit as a byproduct of pomegranate juice (PJ) production. A second pressing of the fruit liberates a complex mixture of hydrolysable polyphenolic compounds normally ingested with pomegranate juice, and these are purified by spray drying. POMx powder is encapsulated for oral administration, with each capsule containing 1,000 mg of pomegranate polyphenols. The present study will determine whether a pomegranate product (POMx or PJ) can decrease skin photoaging, inflammation and skin pathogenic bacteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 30-45 years or older, female and any racial/ethnic group
- •Subjects must understand and sign the informed consent prior to participation
- •Subjects must be in generally good health
- •Subjects must be able and willing to comply with the requirements of the protocol.
排除标准
- •Oral or topical retinoid use within twelve months of entry into the study
- •Non-compliant subjects
- •Taking any antibiotics or other medication or dietary supplements regularly
- •Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for the study
- •Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
- •Allergic to pomegranate products
研究组 & 干预措施
Pomegranate Juice
15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of pomegranate juice on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.
干预措施: Pomegranate Juice (Dietary Supplement)
Placebo
15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of placebo on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.
干预措施: Placebo (Dietary Supplement)
Pomegranate Extract
15 healthy subjects, ages 30-45 years who meet all the eligibility criteria in the screening phase of the study will be assigned to the Pomx arm of the study to evaluate the clinical efficacy of pomegranate extract on skin inflammation and aging. Subjects will be asked to take Pomx 1/day for 12 weeks.
干预措施: Pomegranate Extract (Dietary Supplement)
结局指标
主要结局
Change in inflammatory markers between pomegranate extract and pomegranate juice versus placebo.
时间窗: Baseline and 12 weeks
Utilization of a two-sample t-test to compare the change in between the three groups
次要结局
- Linear mixed effects models to evaluate effect of treatment of time trends and demographic covariates(Baseline and 12 weeks)
研究者
Zhaoping Li
Professor of Medicine
University of California, Los Angeles