Biomarkers of Broccoli Intake: A Pilot Study

Healthy Volunteers Clinical Trial

Official title:

Biomarkers of Broccoli Intake: A Pilot Study to Characterize Novel Metabolites by Targeted Metabolic Profiling and Non-Targeted Metabolomics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287115
• Other study ID #: HS58
• Status: Completed
• Phase: N/A
• First received: September 15, 2017
• Last updated: November 20, 2017
• Start date: November 6, 2017
• Est. completion date: November 17, 2017

Study information

• Verified date: November 2017
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of the study are 1) to characterize plasma and urinary metabolites that originate from glucobrassicin, 1-methoxyglucobrassicin, 4-methoxyglucobrassicin, and 4-hydroxyglucobrassicin, which are the major indole glucosinolates found in broccoli, and 2) to identify novel plasma and urinary metabolites following broccoli consumption that may have roles in reducing the risk of cancer.

Description:

Consumption of Brassica vegetables is inversely associated with incidence of several cancers, including cancer of the lung, stomach, liver, colon, rectum, breast, endometrium, and ovaries. Brassicas are a good source of many nutrients, but the unique characteristic of Brassicas is their rich content of glucosinolates. Breakdown products of indole glucosinolates in Brassica vegetables show promise for reducing the risk of cancer, but have received comparatively less research attention than those of aliphatic glucosinolates. The aim of this study is to investigate plasma and urinary metabolites of indole glucosinolates from broccoli and to identify novel metabolites that may have roles in reducing cancer risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Non tobacco user

• Cancer Free

• Not currently taking glucosinolate/isothiocyanate containing supplements

Exclusion Criteria:

• Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots

• Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)

• History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations

• Pregnant, lactating, or intending to become pregnant during the study period

• Crohn's disease or diverticulitis

• Suspected or known strictures, fistulas or physiological/mechanical GI obstruction

• Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Broccoli consumption
All subjects will eat broccoli on day 11

Locations

Country	Name	City	State
United States	USDA-ARS, Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in glucosinolate metabolites will be measured in blood plasma and urine.	To track the changes of indole glucosinolate metabolites, glucosinolate metabolites will be measured in both blood plasma and urine.	On Day 11