Discovery of Biological Signatures for Cruciferous Vegetable Intake (Single Serving)

August 4, 2026 updated by: Emily Ho, Oregon State University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Corvallis, Oregon, United States, 97331
        • Oregon State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Broccoli sprouts
Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).
Other: Broccoli sprouts
Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).
Active Comparator: Deuterium oxide-labeled broccoli sprouts
Subjects will consume one serving (about 1 cup) of deuterium oxide-labeled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).
Other: Deuterium oxide-labelled broccoli sprouts
Subjects will consume one serving (about 1 cup) of deuterium oxide-labelled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).
Placebo Comparator: Alfalfa sprouts
Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).
Other: Alfalfa sprouts
Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).
Placebo Comparator: Deuterium oxide-labeled alfalfa sprouts
Subjects will consume one serving (about 1 cup) of deuterium oxide-labeled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).
Other: Deuterium oxide-labelled alfalfa sprouts
Subjects will consume one serving (about 1 cup) of deuterium oxide-labelled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
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
Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
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
Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
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
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
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
Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Agriculture (USDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily Ho, PhD, Oregon State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LPI-8343
  • 2020-67001-31214 (Other Grant/Funding Number: NIFA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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