Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers

Healthy Volunteers Clinical Trial

Official title:

Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013465
• Other study ID #: HS55
• Status: Completed
• Phase: N/A
• First received: December 19, 2016
• Last updated: May 23, 2017
• Start date: February 27, 2017
• Est. completion date: May 19, 2017

Study information

• Verified date: May 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 determine the influence of daily consumption of well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine inflammatory marker changes consistent with decreased cancer risk.

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. Brassica vegetables are a good source of many nutrients, but the unique characteristic of Brassicas (Broccoli in particular) is their rich content of glucosinolates. Glucosinolates are sulfur-containing compounds that are converted to isothiocyanates (ITC) by an enzyme in the plant called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. The isothiocyanates are considered to be the active agent for cancer prevention. Some of the mechanisms by which isothiocyanates likely inhibit cancer include modulation of cytochrome P450 enzymes, induction of phase II enzymes, and apoptosis.

The aim of this study is to investigate how daily consumption of broccoli with myrosinase inactivated by cooking influences glucosinolate metabolism and absorption, and consequent regulation of inflammatory markers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 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 (anisinidione)

• History of bariatric surgery or nutrient malabsorption disease

• 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:
• Control Diet
Participants will receive a controlled diet with 0 g/d of broccoli. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
• Base Diet with Broccoli
Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.

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 change of endogenous broccoli isothiocyanates in this crossover study, glucosinolate metabolites will be measured in both blood plasma and urine	At end of diet period 1 (week 3) and at the end of diet period 2 (week 12)
Secondary	Body composition will be determined by dual energy x-ray absorptiometry (DEXA)	Determine fat, lean, and bone mineral mass, and visceral fat deposition in our subjects	Day 0, just prior to beginning the controlled diet
Secondary	The ability of fecal microbiota to metabolize glucosinolates will be determined	Fecal samples will be presented with glucoraphanin to determine the ability of fecal microbes to metabolize it	once per week during diet periods 1 and 2 (weeks 1, 2, 3, 10, 11, and 12)
Secondary	Fecal microbiota will be analyzed for microbial DNA	Fecal microbial communities will be determined using DNA extracted from fecal samples	once at the beginning and end of diet periods 1 and 2 (weeks 1, 3, 10, and 12)
Secondary	Markers of gut health will be analyzed in blood	Zonulin in blood serum will be measured by ELISA	once in the third week of diet periods 1 and 2 (weeks 3 and 12)
Secondary	Markers of inflammation will be measured in blood	Cytokines and acute phase proteins will be measured in blood	at end of diet period 1 (week 3) and at end of diet period 2 (week 12)