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NCT Number: NCT04641026

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon State University

Corvallis, Oregon, 97331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Broccoli sprouts

Other

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

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).

Alfalfa sprouts

Other

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

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).

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Nov 23, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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