Broccoli Seed Extract and Skin Health
Condition: Skin Inflammation
MeSH terms: Dermatitis; Inflammation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Subjects will come to the Human Performance Lab at assigned times in an overnight fasted
      state (no intake of food or beverages except for water during at least the previous 9 hours).
      Subjects will drop off the urine bottles and provide an overnight fasted blood sample. Skin
      health measurements will involve having probes and tapes applied to the surface of the skin
      to assess various parameters of skin health. Photos of skin areas will be taken. These skin
      health measurements will take about 15 to 30 minutes. A 4-week supply of capsules will be
      provided in supplement trays or bottles, and an additional 24-hour urine collection kit will
      be given to each subject. Subjects will be contacted weekly by the Research Manager to ensure
      adherence to the supplementation regimen (2 capsules per day, 4 weeks). Visit #3: Repeat
      visit #2 test procedures. Subjects will come to the Human Performance Lab at assigned times
      in an overnight fasted state after 4 weeks of supplementation. Subjects will drop off the
      urine bottles and provide a blood sample. Body composition and blood pressure measurements
      will be repeated. Skin health measurements will be repeated. An additional 24-hour urine
      collection kit will be given to each subject. Subjects will be instructed to return to the
      lab after the 2-week washout period.

      Visits #4 and #5: Repeated procedures from visits #2 and #3. Subjects will crossover to the
      opposite trial supplement and repeat all study procedures.
    

Intervention name(s): Broccoli, mustard, vitamin C; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules per day for 4 weeks; 2 capsules per day for 4 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blinded, placebo-controlled, crossover design with 4-week supplementation periods and a 2-week washout period.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: broccoli; Glucoraphanin; inflammation; skin; sulforaphane (