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Clinical Trials/NCT04641026
NCT04641026
Active, not recruiting
Not Applicable

Discovery of Biological Signatures for Cruciferous Vegetable Intake: Integration of the Broccoli- and Host-derived Metabolome and the Microbiome

Oregon State University1 site in 1 country83 target enrollmentFebruary 22, 2021
ConditionsDiet, Healthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diet, Healthy
Sponsor
Oregon State University
Enrollment
83
Locations
1
Primary Endpoint
Urine sulforaphane
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 22, 2021
End Date
December 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Ho

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

Oregon State University

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

Outcomes

Primary Outcomes

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

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

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

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

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

Study Sites (1)

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