Sulforaphane BioavailabilityNCT04946526
Broccoli Sulforaphane Bioavailability With Mustard
A study testing Broccoli seed extract and Broccoli seed extract with mustard seed powder in people with Sulforaphane Bioavailability, run by Appalachian State University at 1 site in United States.
Trial summary
We know that broccoli is a vegetable that is associated with a number of health benefits and is a good choice in a healthy diet. Researchers at major universities, including Johns Hopkins University, have identified nutrients in broccoli that have specific health benefits such as improving antioxidant protection. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sulforaphane Bioavailability
- What is being tested?
- Broccoli seed extract and Broccoli seed extract with mustard seed powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Sep 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both male and female subjects will be included
- Age between 25-65 years inclusive
- Non-smoker
- Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures
- Body Mass Index (BMI) of 20 - 29.9 kg/m2
- Willingness to adhere to dietary restrictions: refrain from consuming cruciferous vegetables and condiments that might contain glucosinolates or isothiocyanates (e.g., prepared mustard aka deli mustard, mustard greens, horseradish, wasabi, mayonnaise) for 3 days before and for the duration of the study
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- Subjects willing to consume the light breakfast consisting of a muffin and 12 oz coffee
- Subjects willing to collect all urine for 24 hours on two separate occasions
- Subjects that have given voluntary, written, informed consent to participate in the study
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
- Use of laxative medications or other products that promote colon cleansing in the last 4 weeks
- History of malabsorption or GI tract disorders or GI surgeries (i.e. lapband, gastric bypass, etc.)
- Supplementation with broccoli sprout, seed or powder extracts, or other over the counter supplements including the other bioactive ingredients in the test supplement, antioxidants and multi-vitamin mineral supplements, including vitamin C (ascorbic acid), for the previous 2 weeks
- Subject has a known allergy or intolerance to any of the ingredients contained in the test supplements (e.g. broccoli, broccoli seeds, mustard seeds, vitamin C (ascorbic acid))
- Subject is currently pregnant, planning to become pregnant, or is 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: Bioavailability of Sulforaphane From a Glucoraphanin-Rich Broccoli Seed Supplement With or Without Added Myrosinase From Mustard Seed Powder
We know that broccoli is a vegetable that is associated with a number of health benefits and is a good choice in a healthy diet. Researchers at major universities, including Johns Hopkins University, have identified nutrients in broccoli that have specific health benefits such as improving antioxidant protection. One of these nutrients is called glucoraphanin (GR). However, in order for GR to deliver health benefits in the human body, it first has to be converted to its active form, sulforaphane (SF). This conversion can happen one of two ways. GR can be converted to SF by our gut bacteria (the microbiota) or it can be converted to SF by an enzyme called myrosinase that is naturally occurring in certain plants, including mustard (the same mustard that is used to make table mustard spread and mayonnaise). The purpose of the present study is to test in healthy human volunteers the oral bioavailability (absorption) of GR in broccoli seed extract (BSE) with or without the presence of active plant myrosinase in mustard seed powder (MSP) delivered in a nutritional supplement.
Read the detailed description
The aim of the present study is to determine in healthy human volunteers the oral bioavailability of sulforaphane (SF) derived from broccoli seed extract (BSE) standardized to glucoraphanin (GR) content with and without the presence of active plant myrosinase derived from mustard seed powder. Once absorbed, SF is rapidly metabolized by initial conjugation with the endogenous nucleophile glutathione (GSH). The glutathione conjugate then undergoes successive steps of hydrolysis leading ultimately to the formation of the N-acetylcysteine derivatives (mercapturic acids). All of these conjugates are chemically designated dithiocarbamates (DTC) and can be quantified in the blood and urine by mass spectroscopy (MS). Based on previous published studies, it is expected that the conversion of the oral dose of 115 umol of GR to DTC will be about 30-40% (on a molar basis) when GR is co-delivered with mustard seed powder myrosinase, but only 10% when delivered without the myrosinase source. Blood samples will be collected to determine if the supplements influence biomarkers for oxidative stress and inflammation. The stool sample will be used to measure the alpha-diversity of the gut microbiome and whether this has an influence on urine levels of SF and DTC.
This study will include 16 male and female adults ages 25 to 65 years, and employ a randomized crossover design, with a 7 day washout period between trials. Supplements (broccoli seed extract, BSE, and vitamin C (VC) with or without mustard seed powder, MSP) will be in identical capsules, with the double blind code held by the sponsor until after the study is over.
Participants will be recruited and then contacted prior to visit #1 to determine if they match the criteria for entry into the study. Participants will record food and beverages consumed during the evening meal prior to visit #1. Participants will also be instructed to refrain from consuming cruciferous vegetables and condiments that might contain glucosinolates or isothiocyanates (e.g., mustard, horseradish, wasabi, mayonnaise) for 3 days before and during the duration of the study.
Visit #1: Screening, Orientation, Supplementation and Basic Study Procedures Participants will come to the Human Performance Lab (600 Laureate Way, North Carolina Research Campus, Kannapolis, NC) at 7:00, 8:00, or 9:00 am after an overnight fast (at least 9 hours) having avoided consumption of cruciferous vegetables and condiments for at least three days. This visit will begin with a review of the consent form. Height, body weight, body composition (i.e., percent body fat measured on a special scale that participants stand on with bare feet), and blood pressure (automated unit, Omron Healthcare, Inc. Lake Forest, IL, IntelliSense Blood Pressure Monitor Model: HEM-907XL) will be measured in a private section of the lab. The food record for the prior evening meal will be turned in and reviewed with instructions to consume the same meal the evening before Visit #3. Participants will next provide a spot urine sample in a private stall in the restroom. A mid-stream urine sample will be collected in a cup. Next, participants will be randomized to consume 2 capsules containing either BSE + VC or BSE+VC+MSP along with 8 oz. of water. Participants will consume all of the water along with the 2 capsules. The two supplements will be in identical looking capsules so that participants will not be able to determine their identity. Participants and the research will not know which capsules were received at visits 1 or 3 until the study is over. Following intake of the supplement, participants will consume a muffin and coffee within 15 minutes of taking the supplement. Participants will abstain from eating any food or beverages except for water for 2 hours following consumption of the supplement. After the 2-h delay, participants can resume their normal dietary patterns. Participants will collect all urine for the 24 h period after consuming the supplements. Participants will collect all urine for the first 8 hours in one container, and then collect the remaining 8-24 h of urine in a second container. This first visit will take about 1 hour.
Visit #2: Return urine samples and provide blood sample Participants will come to the lab in an overnight fasted state the next morning, drop off the urine collection containers, and provide a blood sample. A stool collection kit with instructions will be given to each participant. (Instructions are included in the forms file attached to this application).
One Day Prior to Visit #3 Participants will collect a small swab sample of stool in a container provided by the lab on Visit #1. Participants will consume the same dinner that was consumed prior to Visit #1.
Visit #3: Supplementation and Basic Study Procedures One week after visit #1, participants will return to the Human Performance Lab at the same time in an overnight fasted state. All the procedures from Visit #1 will be repeated except that participants will consume the opposite supplement.
Visit #4: Return urine samples and provide blood sample Participants (overnight fasted state) will drop off the final urine collection containers at the lab the next morning and provide the fourth and final blood sample.
- Conditions
- Sulforaphane Bioavailability
- Being tested
- Broccoli seed extract, Broccoli seed extract with mustard seed powder
- Keywords
- broccoli, mustard, sulforaphane, glucoraphanin, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli seed extractDietary supplement
2 capsules, one dose
Broccoli seed extract with mustard seed powderDietary supplement
2 capsules, one dose
| Study group | Role | What they receive |
|---|---|---|
| Broccoli seed extract | Active comparator | A single dose dietary supplement made up of 385 mg broccoli seed extract delivering 50 mg GR (115 umol GR) and 100 mg vitamin C (as ascorbic acid). Receives: Dietary Supplement: Broccoli seed extract |
| Broccoli seed extract with mustard seed powder | Experimental | A single dose dietary supplement made up of a mixture of 385 mg broccoli seed extract delivering 50 mg GR (115 umol GR), 145 mg mustard seed powder containing enough active myrosinase (enzyme) to fully hydrolyze the GR in the capsule to SF post-ingestion (~30 units myrosinase activity) and 100 mg vitamin C (as ascorbic acid). Receives: Dietary Supplement: Broccoli seed extract with mustard seed powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentration of sulforaphane
Broccoli glucosinolate metabolite
Measured: Change from pre-ingestion to 8- and 24-hours post-ingestion
Secondary outcomes (1)
Urine concentration of dithiocarbamate
Broccoli glucosinolate metabolite
Measured: Change from pre-ingestion to 8- and 24-hours post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jun 2022
- Primary completion30 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sulforaphane BioavailabilityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover with a 7 day washout period between trials.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- Brassica Foundation for Chemoprotection Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946526
- Sponsor's protocol ID
- 21-0216
- Status last verified
- Jan 2023
- First submitted
- 17 Jun 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request, will share de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Sulforaphane From a Glucoraphanin-Rich Broccoli Seed Supplement With or Without Added Myrosinase From Mustard Seed Powder
- ClinicalTrials.gov ID
- NCT04946526
- Acronym / sponsor ID
- 21-0216
- Conditions
- Sulforaphane Bioavailability
- Keywords
- broccoli, mustard, sulforaphane, glucoraphanin, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- Brassica Foundation for Chemoprotection Research
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 1 Jul 2021 (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.
We know that broccoli is a vegetable that is associated with a number of health benefits and is a good choice in a healthy diet. Researchers at major universities, including Johns Hopkins University, have identified nutrients in broccoli that have specific health benefits such as improving antioxidant protection. One of these nutrients is called glucoraphanin (GR). However, in order for GR to deliver health benefits in the human body, it first has to be converted to its active form, sulforaphane (SF). This conversion can happen one of two ways. GR can be converted to SF by our gut bacteria (the microbiota) or it can be converted to SF by an enzyme called myrosinase that is naturally occurring in certain plants, including mustard (the same mustard that is used to make table mustard spread and mayonnaise). The purpose of the present study is to test in healthy human volunteers the oral bioavailability (absorption) of GR in broccoli seed extract (BSE) with or without the presence of active plant myrosinase in mustard seed powder (MSP) delivered in a nutritional supplement.
Detailed description
The aim of the present study is to determine in healthy human volunteers the oral bioavailability of sulforaphane (SF) derived from broccoli seed extract (BSE) standardized to glucoraphanin (GR) content with and without the presence of active plant myrosinase derived from mustard seed powder. Once absorbed, SF is rapidly metabolized by initial conjugation with the endogenous nucleophile glutathione (GSH). The glutathione conjugate then undergoes successive steps of hydrolysis leading ultimately to the formation of the N-acetylcysteine derivatives (mercapturic acids). All of these conjugates are chemically designated dithiocarbamates (DTC) and can be quantified in the blood and urine by mass spectroscopy (MS). Based on previous published studies, it is expected that the conversion of the oral dose of 115 umol of GR to DTC will be about 30-40% (on a molar basis) when GR is co-delivered with mustard seed powder myrosinase, but only 10% when delivered without the myrosinase source. Blood samples will be collected to determine if the supplements influence biomarkers for oxidative stress and inflammation. The stool sample will be used to measure the alpha-diversity of the gut microbiome and whether this has an influence on urine levels of SF and DTC.
This study will include 16 male and female adults ages 25 to 65 years, and employ a randomized crossover design, with a 7 day washout period between trials. Supplements (broccoli seed extract, BSE, and vitamin C (VC) with or without mustard seed powder, MSP) will be in identical capsules, with the double blind code held by the sponsor until after the study is over.
Participants will be recruited and then contacted prior to visit #1 to determine if they match the criteria for entry into the study. Participants will record food and beverages consumed during the evening meal prior to visit #1. Participants will also be instructed to refrain from consuming cruciferous vegetables and condiments that might contain glucosinolates or isothiocyanates (e.g., mustard, horseradish, wasabi, mayonnaise) for 3 days before and during the duration of the study.
Visit #1: Screening, Orientation, Supplementation and Basic Study Procedures Participants will come to the Human Performance Lab (600 Laureate Way, North Carolina Research Campus, Kannapolis, NC) at 7:00, 8:00, or 9:00 am after an overnight fast (at least 9 hours) having avoided consumption of cruciferous vegetables and condiments for at least three days. This visit will begin with a review of the consent form. Height, body weight, body composition (i.e., percent body fat measured on a special scale that participants stand on with bare feet), and blood pressure (automated unit, Omron Healthcare, Inc. Lake Forest, IL, IntelliSense Blood Pressure Monitor Model: HEM-907XL) will be measured in a private section of the lab. The food record for the prior evening meal will be turned in and reviewed with instructions to consume the same meal the evening before Visit #3. Participants will next provide a spot urine sample in a private stall in the restroom. A mid-stream urine sample will be collected in a cup. Next, participants will be randomized to consume 2 capsules containing either BSE + VC or BSE+VC+MSP along with 8 oz. of water. Participants will consume all of the water along with the 2 capsules. The two supplements will be in identical looking capsules so that participants will not be able to determine their identity. Participants and the research will not know which capsules were received at visits 1 or 3 until the study is over. Following intake of the supplement, participants will consume a muffin and coffee within 15 minutes of taking the supplement. Participants will abstain from eating any food or beverages except for water for 2 hours following consumption of the supplement. After the 2-h delay, participants can resume their normal dietary patterns. Participants will collect all urine for the 24 h period after consuming the supplements. Participants will collect all urine for the first 8 hours in one container, and then collect the remaining 8-24 h of urine in a second container. This first visit will take about 1 hour.
Visit #2: Return urine samples and provide blood sample Participants will come to the lab in an overnight fasted state the next morning, drop off the urine collection containers, and provide a blood sample. A stool collection kit with instructions will be given to each participant. (Instructions are included in the forms file attached to this application).
One Day Prior to Visit #3 Participants will collect a small swab sample of stool in a container provided by the lab on Visit #1. Participants will consume the same dinner that was consumed prior to Visit #1.
Visit #3: Supplementation and Basic Study Procedures One week after visit #1, participants will return to the Human Performance Lab at the same time in an overnight fasted state. All the procedures from Visit #1 will be repeated except that participants will consume the opposite supplement.
Visit #4: Return urine samples and provide blood sample Participants (overnight fasted state) will drop off the final urine collection containers at the lab the next morning and provide the fourth and final blood sample.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized crossover with a 7 day washout period between trials.
| Arm | Type | Receives |
|---|---|---|
| Broccoli seed extract | Active comparator | Dietary Supplement: Broccoli seed extractA single dose dietary supplement made up of 385 mg broccoli seed extract delivering 50 mg GR (115 umol GR) and 100 mg vitamin C (as ascorbic acid). |
| Broccoli seed extract with mustard seed powder | Experimental | Dietary Supplement: Broccoli seed extract with mustard seed powderA single dose dietary supplement made up of a mixture of 385 mg broccoli seed extract delivering 50 mg GR (115 umol GR), 145 mg mustard seed powder containing enough active myrosinase (enzyme) to fully hydrolyze the GR in the capsule to SF post-ingestion (~30 units myrosinase activity) and 100 mg vitamin C (as ascorbic acid). |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Both male and female subjects will be included
- Age between 25-65 years inclusive
- Non-smoker
- Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures
- Body Mass Index (BMI) of 20 - 29.9 kg/m2
Key exclusion criteria (8 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
- Use of laxative medications or other products that promote colon cleansing in the last 4 weeks
- History of malabsorption or GI tract disorders or GI surgeries (i.e. lapband, gastric bypass, etc.)
- Supplementation with broccoli sprout, seed or powder extracts, or other over the counter supplements including the other bioactive ingredients in the test supplement, antioxidants and multi-vitamin mineral supplements, including vitamin C (ascorbic acid), for the previous 2 weeks
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 seed extract2 capsules, one dose | Dietary supplement | Broccoli seed extract |
| Broccoli seed extract with mustard seed powder2 capsules, one dose | Dietary supplement | Broccoli seed extract with mustard seed powder |
Primary outcome
Urine concentration of sulforaphane
Time frame: Change from pre-ingestion to 8- and 24-hours post-ingestion
Broccoli glucosinolate metabolite
1 secondary outcome
Urine concentration of dithiocarbamate
Time frame: Change from pre-ingestion to 8- and 24-hours post-ingestion
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 25 Jan 2023.
- Individual participant dataSharing planned: No. Upon request, will share de-identified data.
Related trials for Sulforaphane Bioavailability
Recruiting
Investigating the Bioavailability of Broccoli Extract Supplements
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 seed extract and Broccoli seed extract with mustard seed powder in people with Sulforaphane Bioavailability, 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 9 inclusion and 8 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 25 Jan 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. 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?
Urine concentration of sulforaphane (time frame: Change from pre-ingestion to 8- and 24-hours post-ingestion). 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 25 Jan 2023.