Influence of TrueBroc® Broccoli Seed Extract Supplementation on Skin Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Skin IL-1beta (pg/ml)
研究概览
简要总结
The primary objective of this study is to examine the influence of 4-weeks ingestion of TrueBroc®, (broccoli seed extract, BSE) with mustard seed powder (MSP) on improving skin health by evaluating skin physiological and biochemical parameters. This study will test the effect of BSE and MSP compared to placebo on skin health after 4 weeks supplementation. The study will employ a randomized, crossover design with subjects acting as their own controls.
详细描述
The primary objective of this study is to examine the influence of 4-weeks ingestion of TrueBroc® with mustard seed powder on improving skin health by evaluating skin physiological and biochemical parameters. TrueBroc® Glucoraphanin-Rich Broccoli Seed Extract (TrueBroc®) is a hot water extract of Brassica oleracea var. Italica Plenck (Brassicaceae) seeds. TrueBroc® contains high levels of glucoraphanin, a glucosinolate prominently found in the cruciferous vegetables. This study will use supplements containing 770 mg Broccoli Seed Extract (BSE) with 290 mg mustard seed powder (MSP) and 200 mg vitamin C. Limited data indicate that this mixture enhances glucoraphanin bioavailability. The consumption of the phytochemical glucoraphanin confers a number of benefits including skin health.
Hypothesis: That 4-weeks ingestion of TrueBroc® with MSP compared to placebo will improve skin health.
Study Procedures This study will incorporate a randomized, double-blinded, placebo-controlled, crossover design with 4-week supplementation and a 2-week washout period. Skin measurements and tape stripping samples will be collected pre- and post-4-week supplementation periods. Skin tape stripping samples will be analyzed for oxinflammatory-related outcomes. Blood and 24-hour urine samples will also be collected pre- and post-4-week supplementation periods. These samples will be aliquoted and stored in a freezer for potential analysis of targeted outcomes pending additional funding.
Visit #1: Screening and Consent. Subjects will come to the Human Performance Lab at assigned times. The COVID-19 screening participant form will be filled in by the participant to verify the absence of symptoms or exposure.This visit will begin with a review of the consent form, and the inclusion and exclusion criteria. Height, body weight, body composition (seca BIA), and blood pressure will be measured. Subjects will be given 24-hour collection kits with instructions to collect all urine in the provided jug during the day before visit #2.
Visit #2: Return urine bottles. Provide blood sample. Skin health measurements. Start 4-weeks supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Experimental and placebo capsules (2 consumed per day for 4 weeks) will look identical. Both the investigators and the subjects will be blinded, with the code held by the sponsor until the study and data analysis have been completed.
入排标准
- 年龄范围
- 25 Years 至 57 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both male and female subjects will be included, ages 25 to 57 years.
- •Non-smoker and free of any medical conditions that might affect study measurements.
- •Body mass index (BMI) of 20 - 29.9 kg/m2 (not obese).
- •Willingness to adhere to dietary restrictions: refrain from consuming cruciferous vegetables (or related condiments and supplements) such as broccoli, cauliflower, cabbage, kale, bok choy, arugula, Brussels sprouts, collards, watercress, radishes, prepared mustard condiment, mustard greens, horseradish, wasabi, and mayonnaise for 3 days before and for the duration of the study.
- •Willing to collect all urine for 24 hours and provide four blood samples on four separate occasions.
排除标准
- •Diarrhea or oral antibiotic intake within the last 4 weeks.
- •Use of proton pump inhibitors (PPIs), antacids or other medications that influence stomach acidity.
- •History of malabsorption or GI tract disorders or GI surgeries (i.e. lapband, gastric bypass, etc.).
- •History of allergic reactions or intolerance to any of the ingredients contained in the test supplements (e.g. broccoli, broccoli seeds, mustard seeds, vitamin C).
- •Currently pregnant, planning to become pregnant, or breastfeeding.
- •Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
结局指标
主要结局
Skin IL-1beta (pg/ml)
时间窗: Change from pre-study to post-4 weeks supplementation
Skin inflammation cytokine
次要结局
- Skin pH (arbitrary units)(Change from pre-study to post-4 weeks supplementation)
- Transepidermal water loss (TEWL) (g/m2/h)(Change from pre-study to post-4 weeks supplementation)
- Skin elasticity (arbitrary units)(Change from pre-study to post-4 weeks supplementation)
- Skin pigmentation (melatonin content, no units)(Change from pre-study to post-4 weeks supplementation)
- Skin sebum (arbitrary units)(Change from pre-study to post-4 weeks supplementation)
- Skin hydration (arbitrary units)(Change from pre-study to post-4 weeks supplementation)