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Broccoli Seed Extract and Skin Health

Primary Purpose

Skin Inflammation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Broccoli, mustard, vitamin C
Placebo
Sponsored by
Appalachian State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Inflammation focused on measuring broccoli, Glucoraphanin, inflammation, skin, sulforaphane (

Eligibility Criteria

25 Years - 57 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Appalachian State University Human Performance Lab, North Carolina Research Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Broccoli, mustard, vitamin C

Placebo

Arm Description

770 mg Broccoli Seed Extract (BSE) with 290 mg mustard seed powder (MSP) and 200 mg vitamin C

inactive excipients including microcrystalline cellulose, rice hull, maltodextrin, ascorbyl palmitate and silicon dioxide

Outcomes

Primary Outcome Measures

Skin IL-1beta (pg/ml)
Skin inflammation cytokine

Secondary Outcome Measures

Skin elasticity (arbitrary units)
DermaLab® Combo elasticity probe measurement
Skin pH (arbitrary units)
DermaLab® Combo pH probe measurement
Skin hydration (arbitrary units)
DermaLab® Combo hydration probe measurement
Skin pigmentation (melatonin content, no units)
DermaLab Combo color probe
Transepidermal water loss (TEWL) (g/m2/h)
DermaLab® Combo TEWL probe measurement
Skin sebum (arbitrary units)
DermaLab® Combo sebum probe measurement

Full Information

First Posted
February 16, 2023
Last Updated
June 9, 2023
Sponsor
Appalachian State University
Collaborators
North Carolina State University
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1. Study Identification

Unique Protocol Identification Number
NCT05745636
Brief Title
Broccoli Seed Extract and Skin Health
Official Title
Influence of TrueBroc® Broccoli Seed Extract Supplementation on Skin Health
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Appalachian State University
Collaborators
North Carolina State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Inflammation
Keywords
broccoli, Glucoraphanin, inflammation, skin, sulforaphane (

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blinded, placebo-controlled, crossover design with 4-week supplementation periods and a 2-week washout period.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Broccoli, mustard, vitamin C
Arm Type
Experimental
Arm Description
770 mg Broccoli Seed Extract (BSE) with 290 mg mustard seed powder (MSP) and 200 mg vitamin C
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
inactive excipients including microcrystalline cellulose, rice hull, maltodextrin, ascorbyl palmitate and silicon dioxide
Intervention Type
Dietary Supplement
Intervention Name(s)
Broccoli, mustard, vitamin C
Intervention Description
2 capsules per day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
2 capsules per day for 4 weeks.
Primary Outcome Measure Information:
Title
Skin IL-1beta (pg/ml)
Description
Skin inflammation cytokine
Time Frame
Change from pre-study to post-4 weeks supplementation
Secondary Outcome Measure Information:
Title
Skin elasticity (arbitrary units)
Description
DermaLab® Combo elasticity probe measurement
Time Frame
Change from pre-study to post-4 weeks supplementation
Title
Skin pH (arbitrary units)
Description
DermaLab® Combo pH probe measurement
Time Frame
Change from pre-study to post-4 weeks supplementation
Title
Skin hydration (arbitrary units)
Description
DermaLab® Combo hydration probe measurement
Time Frame
Change from pre-study to post-4 weeks supplementation
Title
Skin pigmentation (melatonin content, no units)
Description
DermaLab Combo color probe
Time Frame
Change from pre-study to post-4 weeks supplementation
Title
Transepidermal water loss (TEWL) (g/m2/h)
Description
DermaLab® Combo TEWL probe measurement
Time Frame
Change from pre-study to post-4 weeks supplementation
Title
Skin sebum (arbitrary units)
Description
DermaLab® Combo sebum probe measurement
Time Frame
Change from pre-study to post-4 weeks supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camila A Olson, PhD
Organizational Affiliation
Appalachian State University
Official's Role
Study Director
Facility Information:
Facility Name
Appalachian State University Human Performance Lab, North Carolina Research Campus
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States

12. IPD Sharing Statement

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Broccoli Seed Extract and Skin Health

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