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

NCT04641026 | Active Not Recruiting

• 2 other identifiers: LPI-83432020-67001-31214
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diet, Healthy

Keywords

broccoli sprout; microbiome; cruciferous vegetable

Outcome Measures

Primary Outcomes (5)

• Urine sulforaphane

  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

  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

  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

  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

  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

Study Arms (4)

Broccoli sprouts

ACTIVE COMPARATOR

Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).

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).

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).

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).

Other: Deuterium oxide-labelled alfalfa sprouts

Interventions

Broccoli sprouts OTHER

Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).

Broccoli sprouts

Deuterium oxide-labelled broccoli sprouts OTHER

Subjects will consume one serving (about 1 cup) of deuterium oxide-labelled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).

Deuterium oxide-labeled broccoli sprouts

Alfalfa sprouts OTHER

Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).

Alfalfa sprouts

Deuterium oxide-labelled alfalfa sprouts OTHER

Subjects will consume one serving (about 1 cup) of deuterium oxide-labelled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).

Deuterium oxide-labeled alfalfa sprouts

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon State University: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

Study Officials

• Emily Ho, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participant is blinded to the presence or absence of deuterium label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endowed Chair and Director, Linus Pauling Institute Professor, College of Public Health and Human Sciences

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 23, 2020
• Study Start: February 22, 2021
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)