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

Sponsor
Oregon State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04641026
Collaborator
United States Department of Agriculture (USDA) (U.S. Fed)
80
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46.3
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Broccoli sprouts
  • Other: Deuterium oxide-labelled broccoli sprouts
  • Other: Alfalfa sprouts
  • Other: Deuterium oxide-labelled alfalfa sprouts
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
participant is blinded to the presence or absence of deuterium label
Primary Purpose:
Basic Science
Official Title:
Discovery of Biological Signatures for Cruciferous Vegetable Intake: Integration of the Broccoli- and Host-derived Metabolome and the Microbiome
Actual Study Start Date :
Feb 22, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. Plasma sulforaphane [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon State University Corvallis Oregon United States 97331

Sponsors and Collaborators

  • Oregon State University
  • United States Department of Agriculture (USDA)

Investigators

  • Principal Investigator: Emily Ho, PhD, Oregon State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emily Ho, Endowed Chair and Director, Linus Pauling Institute Professor, College of Public Health and Human Sciences, Oregon State University
ClinicalTrials.gov Identifier:
NCT04641026
Other Study ID Numbers:
  • LPI-8343
  • 2020-67001-31214
First Posted:
Nov 23, 2020
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Emily Ho, Endowed Chair and Director, Linus Pauling Institute Professor, College of Public Health and Human Sciences, Oregon State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2021