Clinical trial NCT03013465: Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers
Official title: Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2017-01-06
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The change in glucosinolate metabolites will be measured in blood plasma and urine
timeFrame: At end of diet period 1 (week 3) and at the end of diet period 2 (week 12)
Secondary outcomes:
measure: Body composition will be determined by dual energy x-ray absorptiometry (DEXA)
timeFrame: Day 0, just prior to beginning the controlled diet
measure: The ability of fecal microbiota to metabolize glucosinolates will be determined
timeFrame: once per week during diet periods 1 and 2 (weeks 1, 2, 3, 10, 11, and 12)
measure: Fecal microbiota will be analyzed for microbial DNA
timeFrame: once at the beginning and end of diet periods 1 and 2 (weeks 1, 3, 10, and 12)
measure: Markers of gut health will be analyzed in blood
timeFrame: once in the third week of diet periods 1 and 2 (weeks 3 and 12)
measure: Markers of inflammation will be measured in blood
timeFrame: at end of diet period 1 (week 3) and at end of diet period 2 (week 12)
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS, Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References:
citation: Charron CS, Vinyard BT, Jeffery EH, Ross SA, Seifried HE, Novotny JA. BMI Is Associated With Increased Plasma and Urine Appearance of Glucosinolate Metabolites After Consumption of Cooked Broccoli. Front Nutr. 2020 Sep 24;7:575092. doi: 10.3389/fnut.2020.575092. eCollection 2020.