Skin InflammationNCT05745636
Broccoli Seed Extract and Skin Health
A study testing Broccoli, mustard, vitamin C in people with Skin Inflammation, run by Appalachian State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Inflammation
- What is being tested?
- Broccoli, mustard, vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian State University Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, 28081
About this study
Official title: Influence of TrueBroc® Broccoli Seed Extract Supplementation on Skin Health
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.
Read the 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.
- Conditions
- Skin Inflammation
- Being tested
- Broccoli, mustard, vitamin C, Placebo
- Keywords
- broccoli, Glucoraphanin, inflammation, skin, sulforaphane (
- Medical subject headings
- Dermatitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli, mustard, vitamin CDietary supplement
2 capsules per day for 4 weeks
PlaceboDietary supplement
2 capsules per day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Broccoli, mustard, vitamin C | Experimental | 770 mg Broccoli Seed Extract (BSE) with 290 mg mustard seed powder (MSP) and 200 mg vitamin C Receives: Dietary Supplement: Broccoli, mustard, vitamin C |
| Placebo | Placebo comparator | inactive excipients including microcrystalline cellulose, rice hull, maltodextrin, ascorbyl palmitate and silicon dioxide Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin IL-1beta (pg/ml)
Skin inflammation cytokine
Measured: Change from pre-study to post-4 weeks supplementation
Secondary outcomes (6)
Skin elasticity (arbitrary units)
DermaLab® Combo elasticity probe measurement
Measured: Change from pre-study to post-4 weeks supplementation
Skin pH (arbitrary units)
DermaLab® Combo pH probe measurement
Measured: Change from pre-study to post-4 weeks supplementation
Skin hydration (arbitrary units)
DermaLab® Combo hydration probe measurement
Measured: Change from pre-study to post-4 weeks supplementation
Skin pigmentation (melatonin content, no units)
DermaLab Combo color probe
Measured: Change from pre-study to post-4 weeks supplementation
Transepidermal water loss (TEWL) (g/m2/h)
DermaLab® Combo TEWL probe measurement
Measured: Change from pre-study to post-4 weeks supplementation
Skin sebum (arbitrary units)
DermaLab® Combo sebum probe measurement
Measured: Change from pre-study to post-4 weeks supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start13 Mar 2023
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blinded, placebo-controlled, crossover design with 4-week supplementation periods and a 2-week washout period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina State University
- Responsible party
- Sponsor
- Investigators
- Camila A Olson, PhD, Study director, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745636
- Sponsor's protocol ID
- HS-22-42
- Status last verified
- Jun 2023
- First submitted
- 16 Feb 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of TrueBroc® Broccoli Seed Extract Supplementation on Skin Health
- ClinicalTrials.gov ID
- NCT05745636
- Acronym / sponsor ID
- HS-22-42
- Conditions
- Skin Inflammation
- Keywords
- broccoli, Glucoraphanin, inflammation, skin, sulforaphane (
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- North Carolina State University
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled, crossover design with 4-week supplementation periods and a 2-week washout period.
| Arm | Type | Receives |
|---|---|---|
| Broccoli, mustard, vitamin C | Experimental | Dietary Supplement: Broccoli, mustard, vitamin C770 mg Broccoli Seed Extract (BSE) with 290 mg mustard seed powder (MSP) and 200 mg vitamin C |
| Placebo | Placebo comparator | Dietary Supplement: Placeboinactive excipients including microcrystalline cellulose, rice hull, maltodextrin, ascorbyl palmitate and silicon dioxide |
Who may qualify
- Ages
- 25 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broccoli, mustard, vitamin C2 capsules per day for 4 weeks | Dietary supplement | Broccoli, mustard, vitamin C |
| Placebo2 capsules per day for 4 weeks. | Dietary supplement | Placebo |
Primary outcome
Skin IL-1beta (pg/ml)
Time frame: Change from pre-study to post-4 weeks supplementation
Skin inflammation cytokine
6 secondary outcomes
Skin elasticity (arbitrary units)
Time frame: Change from pre-study to post-4 weeks supplementation
Skin pH (arbitrary units)
Time frame: Change from pre-study to post-4 weeks supplementation
Skin hydration (arbitrary units)
Time frame: Change from pre-study to post-4 weeks supplementation
Skin pigmentation (melatonin content, no units)
Time frame: Change from pre-study to post-4 weeks supplementation
Transepidermal water loss (TEWL) (g/m2/h)
Time frame: Change from pre-study to post-4 weeks supplementation
Skin sebum (arbitrary units)
Time frame: Change from pre-study to post-4 weeks supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camila A Olson, PhD study director
Appalachian State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broccoli, mustard, vitamin C in people with Skin Inflammation, run by Appalachian State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin IL-1beta (pg/ml) (time frame: Change from pre-study to post-4 weeks supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.