Status:
COMPLETED
Bioavailability of Phytonutrients From Novel Preparations of Broccoli
Lead Sponsor:
USDA Beltsville Human Nutrition Research Center
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-75 years
Phase:
NA
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...
Detailed 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, rect...
Eligibility Criteria
Inclusion
- Between 21 and 75 years old at beginning of study
Exclusion
- 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
Key Trial Info
Start Date :
April 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03773497
Start Date
April 16 2019
End Date
June 28 2019
Last Update
September 3 2019
Active Locations (1)
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1
USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705