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

Not Applicable

Active, not recruiting

• Conditions: Diet, Healthy

• Registration Number: NCT04641026
• Lead Sponsor: Oregon State University

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.

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-23
• Study Start: 2021-02-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-04
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Urine sulforaphane	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 metabolites	Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts	Change in levels of sulforaphane metabolites in plasma
Urine sulforaphane metabolites	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	Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts	Change in levels of sulforaphane in plasma
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	Change in stool sample based gut microbiome composition using 16S rRNA gene sequencing

Trial Locations

Locations (1)

Oregon State University; 🇺🇸 Corvallis, Oregon, United States