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临床试验/NCT04861623
NCT04861623已完成不适用

A Pilot Clinical Trial to Assess the Effects of 100% Orange Juice on Skin Health in Women Using a Randomized Double-Blinded Placebo-Controlled Crossover Design

University of Florida2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月4日最近更新:
适应症

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
Skin UV sensitivity

研究概览

简要总结

Daily consumption of Orange Juice (OJ) protects skin against UV-induced damages and wrinkling, improves skin barrier function and overall skin health by decreasing oxidative stress, inflammation, and protein glycation. The positive effects of OJ on skin appearance are associated with improvements of the stratum corneum lipidomic and skin microbiome.

详细描述

There is a lack of clinical evidence on how 100% orange juice (OJ) affects skin health. Women make over 90% of the decisions on food purchases for family. Skin health is a major concern for women because skin ageing becomes visibly noticeable after age 30 due to UV exposure, oxidative stress, and collagen glycation. The investigators hypothesize that micronutrients in OJ, including vitamin C, flavanones, and carotenoids, protect skin against photoaging and wrinkling by alleviating oxidative stress, inflammation, and collagen glycation. The investigators further propose that daily OJ consumption (16 oz) will improve skin elasticity, barrier function, overall skin appearance and health. The study hypotheses will be tested in a 12-week clinical trial in 24 women aged 45-65 using a randomized, double-blinded, placebo-controlled, crossover design. Placebo will be formulated using SunnyD orange-flavered beverage to match the color, taste, and calorie content of OJ. This research will measure UV-induced skin erythema, wrinkles, smoothness, roughness, elasticity, hydration, pH, melanin, and transepidermal water loss (a skin barrier index) of skin on both face and forearm. Skin strips and swabs will be collected and preserved for future assessments of skin lipids and colonized microorganisms (skin microbiome) because they are key factors affecting skin health. Positive results from this pilot trial will provide clinical evidence on the effectiveness of OJ to maintain skin health and reduce ageing. This research will be carried out by a research team with the experience and facilities for skin research.

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
Single (Participant)

盲法说明

Participants will be blinded to the identity of the beverages

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI (18.5-29.9)
  • Body weight ≥110 pounds
  • Fitzpatrick skin type 2 and 3.

排除标准

  • pregnancy
  • breast-feeding
  • impaired fasting glucose
  • frequent alcohol use
  • history of skin cancer
  • sunbathing and the use of tanning bed, intake of vitamin/mineral supplements
  • habitual high intake of fruits (≥ 2 cups daily)
  • intake of medication that might influence the outcome of the study

结局指标

主要结局

Skin UV sensitivity

时间窗: Baseline, 84 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 baseline, after 42 and 84 days, skin color will be measured before and 24 hours after irradiation. Skin color will be evaluated by a colorimeter. The a\*-value (red/green-axis) is a measure of reddening (erythema).

次要结局

  • Skin transepidermal water loss(Baseline, 84 days)
  • Skin erythema and melanin index(Baseline, 84 days)
  • skin hydration(Baseline, 84 days)
  • skin pH(Baseline, 84 days)
  • Inflammation biomarkers(Baseline, 84 days)
  • oxidative stress(Baseline, 84 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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