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

NCT03013465 | Completed

• 1 other identifier: HS55
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Body composition will be determined by dual energy x-ray absorptiometry (DEXA)

  Day 0, just prior to beginning the controlled diet

• The ability of fecal microbiota to metabolize glucosinolates will be determined

  once per week during diet periods 1 and 2 (weeks 1, 2, 3, 10, 11, and 12)

• Fecal microbiota will be analyzed for microbial DNA

  once at the beginning and end of diet periods 1 and 2 (weeks 1, 3, 10, and 12)

• Markers of gut health will be analyzed in blood

  once in the third week of diet periods 1 and 2 (weeks 3 and 12)

• Markers of inflammation will be measured in blood

  at end of diet period 1 (week 3) and at end of diet period 2 (week 12)

Study Arms (2)

Control Diet

OTHER

Participants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of broccoli (control).

Other: Control Diet

Brassica Diet

ACTIVE COMPARATOR

Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily.

Other: Base Diet with Broccoli

Interventions

Control Diet OTHER

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.

Also known as: Base Diet

Control Diet

Base Diet with Broccoli OTHER

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.

Brassica Diet

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non tobacco user
• Cancer Free
• Not currently taking glucosinolate/isothiocyanate containing supplements

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead

Study Sites (1)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

• 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.

  PMID: 33072799 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Molecular Biologist

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 6, 2017
• Study Start: February 27, 2017
• Primary Completion: May 19, 2017
• Study Completion: May 19, 2017
• Last Updated: May 25, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)