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

NCT ID: NCT04641026

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Broccoli sprouts

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

Group Type: ACTIVE_COMPARATOR

Broccoli sprouts

Intervention Type: OTHER

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

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).

Group Type: ACTIVE_COMPARATOR

Deuterium oxide-labelled broccoli sprouts

Intervention Type: OTHER

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

Alfalfa sprouts

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

Group Type: PLACEBO_COMPARATOR

Alfalfa sprouts

Intervention Type: OTHER

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

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).

Group Type: PLACEBO_COMPARATOR

Deuterium oxide-labelled alfalfa sprouts

Intervention Type: OTHER

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

Interventions

Broccoli sprouts

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

Intervention Type: 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).

Intervention Type: OTHER

Alfalfa sprouts

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

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

Oregon State University

OTHER

Sponsor Role: lead

Responsible Party

Emily Ho

Endowed Chair and Director, Linus Pauling Institute Professor, College of Public Health and Human Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Ho, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Locations

Oregon State University

Corvallis, Oregon, United States

Countries

United States

Other Identifiers

2020-67001-31214

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LPI-8343

Identifier Type: -

Identifier Source: org_study_id