Bioavailability of Phytonutrients From Novel Preparations of Broccoli

NCT03773497 | Completed

• 1 other identifier: HS63 - Broccoli Snack Study
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the effects of different methods of broccoli preparation on levels of urinary glucosinolate metabolites. The secondary objective is to determine the effects of different methods of broccoli preparation on levels of plasma carotenoids.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Glucosinolate Metabolites will be measured

  Urine will be analyzed for glucosinolate metabolites

  Day 1

• Glucosinolate Metabolites will be measured

  Urine will be analyzed for glucosinolate metabolites

  Day 22

• Glucosinolate Metabolites will be measured

  Urine will be analyzed for glucosinolate metabolites

  Day 43

• Glucosinolate Metabolites will be measured

  Urine will be analyzed for glucosinolate metabolites

  Day 64

Secondary Outcomes (1)

• Carotenoids will be measured

  Days 1, 2, 3, 4, 11, 22, 23, 24, 25, 32, 43, 44, 45, 46, 53, 64, 65, 66, 67, 74

Study Arms (4)

Common snack combination

OTHER

Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of a combination of common snack foods (pretzels, potato chips, and popcorn).

Other: Common Snack Combination

Cheese broccoli

OTHER

Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli.

Other: Cheesy Broccoli Snack

Cheese broccoli with Daikon radish powder

OTHER

Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder.

Other: Cheesy Broccoli with Daikon Radish Snack

Uncooked broccoli with ranch-type dip

OTHER

Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of uncooked, freeze-dried broccoli with ranch-type dip.

Other: Uncooked Broccoli Snack

Interventions

Common Snack Combination OTHER

Combination of Chips, Pretzels, and Popcorn.

Common snack combination

Cheesy Broccoli Snack OTHER

Oven-roasted, freeze-dried, cheese flavored broccoli

Cheese broccoli

Cheesy Broccoli with Daikon Radish Snack OTHER

Oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder

Cheese broccoli with Daikon radish powder

Uncooked Broccoli Snack OTHER

Uncooked, freeze-dried broccoli with ranch-type dip

Uncooked broccoli with ranch-type dip

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 21 and 75 years old at beginning of study

You may not qualify if:

• Pregnant, lactating, or intending to become pregnant during the study period
• Women who have given birth during the previous 12 months
• Presence of kidney disease, liver disease, gout, certain cancers, gastrointestinal disease, hyperthyroidism, untreated or unstable hypothyroidism, pancreatic disease, other metabolic diseases, or malabsorption syndromes requiring special diets
• History of certain cancers within last 3 years
• Known allergy or intolerance to Brassica vegetables
• History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low-fat diets, high-protein diets)
• Colonoscopy during three weeks prior to start of study
• Unwillingness to abstain from probiotics or vitamin, mineral, herbal and glucosinolate/isothiocyanate supplements for two weeks prior to the study and during the study
• Use of tobacco products within 6 months preceding study
• Crohn's disease or diverticulitis
• Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
• Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
• Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
• Fasting glucose greater than or equal to 126 mg/dL
• Unable or unwilling to give informed consent or communicate with study staff

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

Study Design

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

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 12, 2018
• Study Start: April 16, 2019
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)