Diet, HealthyNCT04641026
Discovery of Biological Signatures for Cruciferous Vegetable Intake (Single Serving)
A study testing Broccoli sprouts, Deuterium oxide-labelled broccoli sprouts and Alfalfa sprouts in people with Diet, Healthy, run by Oregon State University at 1 site in United States.
Trial summary
The purpose of this project is to study the molecular and metabolic profiles in human plasma, urine and microbiome composition following the consumption of broccoli sprouts. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Broccoli sprouts, Deuterium oxide-labelled broccoli sprouts and Alfalfa sprouts
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women, 18-60 years of age
- Willing to stop taking herbal and phytochemical (plant-based extract or phytochemical) supplements for 1 week prior to and during the study
- Willing to stop cruciferous vegetable and probiotic supplement, food and beverage intake 1 week prior to and during the study
- Willing to complete a 10-day food diary during the study
- Must be able to give written informed consent
Who cannot join
- Body Mass Index (BMI) <18.5 or >30.0 kg/m2
- Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past three months
- Pregnancy, breastfeeding, or planning to become pregnant before completing the study
- Engaging in vigorous exercise more than 7 hours per week
- Have a significant acute or chronic illness such as cardiovascular disease, kidney or liver disease, diabetes, thyroid disorder, or radiation or chemotherapy treatment for cancer within the past five years.
- Use of medications to control cholesterol (e.g. statins, cholestyramine) or fat absorption (e.g. orlistat)
- Have had bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), other gastrointestinal procedure (e.g. cholecystectomy) or disorders (e.g. Crohn's disease, celiac disease, ulcerative colitis)
- Use of oral antibiotic medication within the 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discovery of Biological Signatures for Cruciferous Vegetable Intake: Integration of the Broccoli- and Host-derived Metabolome and the Microbiome
The purpose of this project is to study the molecular and metabolic profiles in human plasma, urine and microbiome composition following the consumption of broccoli sprouts.
Read the detailed description
The investigators wish to examine metabolic and molecular markers found in blood and in urine after a single dose of sprouts, and evaluate the importance of the gut microbiome on these parameters. Some subjects will receive broccoli sprouts that are grown in deuterium oxide, a commonly used non-toxic, non-radioactive label for vegetables (Tang, Qin et al. 2005), so researchers can identify metabolites in blood and urine that are directly from consumed sprouts. The investigators plan to feed subjects a standardized breakfast and either broccoli sprouts or alfalfa sprouts (control) and look at the presence of metabolites and activity in the blood and urine 3, 6, 24, 48 and 72 hours following intake as well as changes in microbiome composition.
- Conditions
- Diet, Healthy
- Being tested
- Broccoli sprouts, Deuterium oxide-labelled broccoli sprouts, Alfalfa sprouts, Deuterium oxide-labelled alfalfa sprouts
- Keywords
- broccoli sprout, microbiome, cruciferous vegetable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli sproutsOther
Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).
Deuterium oxide-labelled broccoli sproutsOther
Subjects will consume one serving (about 1 cup) of deuterium oxide-labelled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).
Alfalfa sproutsOther
Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).
Deuterium oxide-labelled alfalfa sproutsOther
Subjects will consume one serving (about 1 cup) of deuterium oxide-labelled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).
| Study group | Role | What they receive |
|---|---|---|
| Broccoli sprouts | Active comparator | Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice). Receives: Other: Broccoli sprouts |
| Deuterium oxide-labeled broccoli sprouts | Active comparator | Subjects will consume one serving (about 1 cup) of deuterium oxide-labeled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice). Receives: Other: Deuterium oxide-labelled broccoli sprouts |
| Alfalfa sprouts | Placebo comparator | Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice). Receives: Other: Alfalfa sprouts |
| Deuterium oxide-labeled alfalfa sprouts | Placebo comparator | Subjects will consume one serving (about 1 cup) of deuterium oxide-labeled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice). Receives: Other: Deuterium oxide-labelled alfalfa sprouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine sulforaphane
Change in levels of sulforaphane metabolites in urine
Measured: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Urine sulforaphane metabolites
Change in levels of sulforaphane metabolites in urine
Measured: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Plasma sulforaphane
Change in levels of sulforaphane in plasma
Measured: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Plasma sulforaphane metabolites
Change in levels of sulforaphane metabolites in plasma
Measured: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Stool sample based gut microbiome composition using 16S rRNA gene sequencing
Change in stool sample based gut microbiome composition using 16S rRNA gene sequencing
Measured: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start22 Feb 2021
- Primary completion15 Dec 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Emily Ho, Oregon State University
- Investigators
- Emily Ho, PhD, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641026
- Sponsor's protocol ID
- LPI-8343
- Other IDs
- 2020-67001-31214
- Status last verified
- Aug 2026
- First submitted
- 29 Oct 2020
- Last updated
- 7 Aug 2026
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of Biological Signatures for Cruciferous Vegetable Intake: Integration of the Broccoli- and Host-derived Metabolome and the Microbiome
- ClinicalTrials.gov ID
- NCT04641026
- Acronym / sponsor ID
- LPI-8343
- Conditions
- Diet, Healthy
- Keywords
- broccoli sprout, microbiome, cruciferous vegetable
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Nov 2020 (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 purpose of this project is to study the molecular and metabolic profiles in human plasma, urine and microbiome composition following the consumption of broccoli sprouts.
Detailed description
The investigators wish to examine metabolic and molecular markers found in blood and in urine after a single dose of sprouts, and evaluate the importance of the gut microbiome on these parameters. Some subjects will receive broccoli sprouts that are grown in deuterium oxide, a commonly used non-toxic, non-radioactive label for vegetables (Tang, Qin et al. 2005), so researchers can identify metabolites in blood and urine that are directly from consumed sprouts. The investigators plan to feed subjects a standardized breakfast and either broccoli sprouts or alfalfa sprouts (control) and look at the presence of metabolites and activity in the blood and urine 3, 6, 24, 48 and 72 hours following intake as well as changes in microbiome composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Broccoli sprouts | Active comparator | Other: Broccoli sproutsSubjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice). |
| Deuterium oxide-labeled broccoli sprouts | Active comparator | Other: Deuterium oxide-labelled broccoli sproutsSubjects will consume one serving (about 1 cup) of deuterium oxide-labeled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice). |
| Alfalfa sprouts | Placebo comparator | Other: Alfalfa sproutsSubjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice). |
| Deuterium oxide-labeled alfalfa sprouts | Placebo comparator | Other: Deuterium oxide-labelled alfalfa sproutsSubjects will consume one serving (about 1 cup) of deuterium oxide-labeled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men and women, 18-60 years of age
- Willing to stop taking herbal and phytochemical (plant-based extract or phytochemical) supplements for 1 week prior to and during the study
- Willing to stop cruciferous vegetable and probiotic supplement, food and beverage intake 1 week prior to and during the study
- Willing to complete a 10-day food diary during the study
- Must be able to give written informed consent
Key exclusion criteria (8 listed)
- Body Mass Index (BMI) <18.5 or >30.0 kg/m2
- Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past three months
- Pregnancy, breastfeeding, or planning to become pregnant before completing the study
- Engaging in vigorous exercise more than 7 hours per week
- Have a significant acute or chronic illness such as cardiovascular disease, kidney or liver disease, diabetes, thyroid disorder, or radiation or chemotherapy treatment for cancer within the past five years.
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 sproutsSubjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice). | Other | Broccoli sprouts |
| Deuterium oxide-labelled broccoli sproutsSubjects will consume one serving (about 1 cup) of deuterium oxide-labelled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice). | Other | Deuterium oxide-labeled broccoli sprouts |
| Alfalfa sproutsSubjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice). | Other | Alfalfa sprouts |
| Deuterium oxide-labelled alfalfa sproutsSubjects will consume one serving (about 1 cup) of deuterium oxide-labelled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice). | Other | Deuterium oxide-labeled alfalfa sprouts |
Primary outcome
Urine sulforaphane
Time frame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Change in levels of sulforaphane metabolites in urine
Urine sulforaphane metabolites
Time frame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Change in levels of sulforaphane metabolites in urine
Plasma sulforaphane
Time frame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Change in levels of sulforaphane in plasma
Plasma sulforaphane metabolites
Time frame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Change in levels of sulforaphane metabolites in plasma
Stool sample based gut microbiome composition using 16S rRNA gene sequencing
Time frame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Change in stool sample based gut microbiome composition using 16S rRNA gene sequencing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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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.
Emily Ho, PhD principal investigator
Oregon 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 sprouts, Deuterium oxide-labelled broccoli sprouts and Alfalfa sprouts in people with Diet, Healthy, run by Oregon 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 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 sulforaphane (time frame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts). The study lists 5 primary outcomes in all. 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 7 Aug 2026.