Bioavailability of Phytonutrients From Novel Preparations of Broccoli

Healthy Volunteers Clinical Trial

Official title:

Bioavailability of Phytonutrients From Novel Preparations of Broccoli

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773497
• Other study ID #: HS63 - Broccoli Snack Study
• Status: Completed
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: June 28, 2019

Study information

• Verified date: August 2019
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Consumption of Brassica vegetables (which include broccoli, cabbage, and kale) is inversely associated with the incidence of several cancers, including cancers of the lung, stomach, liver, colon, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source of many nutrients including glucosinolates and carotenoids. Glucosinolates are sulfur-containing compounds that are converted to bioactive metabolites by an enzyme called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. These bioactive compounds are considered to be active agents for cancer prevention. Their ability to reduce risk of cancer may derive in part from their ability to modulate foreign-substance metabolizing enzymes, which include enzymes called Phase I cytochrome P450s and Phase II enzymes. Carotenoids may also have a role in cancer prevention and other health benefits including reducing age-related macular degeneration, and therefore merit research to reveal factors that affect their presence in the body.

The primary aim of this study is to investigate how various preparations of broccoli impact levels of these healthful nutrients in humans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Between 21 and 75 years old at beginning of study

Exclusion Criteria:

• 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

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

• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Common Snack Combination
Combination of Chips, Pretzels, and Popcorn.
• Cheesy Broccoli Snack
Oven-roasted, freeze-dried, cheese flavored broccoli
• Cheesy Broccoli with Daikon Radish Snack
Oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder
• Uncooked Broccoli Snack
Uncooked, freeze-dried broccoli with ranch-type dip

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	Glucosinolate Metabolites will be measured	Urine will be analyzed for glucosinolate metabolites	Day 1
Primary	Glucosinolate Metabolites will be measured	Urine will be analyzed for glucosinolate metabolites	Day 22
Primary	Glucosinolate Metabolites will be measured	Urine will be analyzed for glucosinolate metabolites	Day 43
Primary	Glucosinolate Metabolites will be measured	Urine will be analyzed for glucosinolate metabolites	Day 64
Secondary	Carotenoids will be measured	Carotenoids will be extracted from plasma	Days 1, 2, 3, 4, 11, 22, 23, 24, 25, 32, 43, 44, 45, 46, 53, 64, 65, 66, 67, 74