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

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: Active, not recruiting
• Conditions: Diet, Healthy
• Intervention / Treatment: Other: Broccoli sprouts; Other: Deuterium oxide-labelled broccoli sprouts; Other: Alfalfa sprouts; Other: Deuterium oxide-labelled alfalfa 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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oregon State University
• Collaborators: United States Department of Agriculture (USDA)
• Investigators: Principal Investigator: Emily Ho, PhD, Oregon State University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: microbiome; broccoli sprout; cruciferous vegetable
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Radiation-Protective Agents; Deuterium Oxide
• Other Study ID 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