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

Diet, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04641026
• Other study ID #: LPI-8343
• Secondary ID: 2020-67001-31214
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Oregon State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy

Intervention

Other:
• Broccoli sprouts
Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).
• 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).
• Alfalfa sprouts
Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).
• 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).

Locations

Country	Name	City	State
United States	Oregon State University	Corvallis	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon State University	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine sulforaphane	Change in levels of sulforaphane metabolites in urine	Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Primary	Urine sulforaphane metabolites	Change in levels of sulforaphane metabolites in urine	Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Primary	Plasma sulforaphane	Change in levels of sulforaphane in plasma	Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Primary	Plasma sulforaphane metabolites	Change in levels of sulforaphane metabolites in plasma	Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Primary	Stool sample based gut microbiome composition using 16S rRNA gene sequencing	Change in 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