Clinical trial NCT03449849: Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes
Official title: Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2018-02-28
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective of this study is to determine how daily consumption of kale changes the activity of human xenobiotic metabolizing enzymes. Secondary objectives are to measure absorption and metabolism of kale phytonutrients, and to determine how kale consumption affects gene expression related to metabolism and lipid measures associated with cardiovascular health.

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, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source of many nutrients, but the unique characteristic of Brassicas is their rich content of glucosinolates. Glucosinolates are sulfur-containing compounds that are converted to bioactive metabolites by a plant enzyme called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. These bioactive compounds are considered to be the active agent 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.

The primary aim of this study is to investigate how daily consumption of kale influences foreign-substance metabolizing enzymes, which in turn may reduce cancer risk. Secondary aims of this study include measuring metabolism of kale nutrients, effect of kale consumption on fecal microbiota, and how kale consumption influences risk factors for cardiovascular disease.

Eligibility criteria: Inclusion Criteria:

* 5 years cancer free
* Not a tobacco product user
* Blood glucose less than 126 mg/dL
* Able to voluntarily agree to participate and sign an informed consent document

Exclusion Criteria:

* Brassica vegetable allergy or intolerance
* use of oral contraceptives
* Women who have given birth in the previous 12 months
* 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 (anisindione)
* 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: CYP1A2 activity will be analyzed
timeFrame: Day 7
measure: CYP1A2 activity will be analyzed
timeFrame: Day 14
measure: CYP1A2 activity will be analyzed
timeFrame: Day 42
measure: CYP1A2 activity will be analyzed
timeFrame: Day 49
Secondary outcomes:
measure: The ability of fecal microbiota to metabolize glucosinolates will be determined
timeFrame: Days 14 and 49.
measure: Metabolites of Kale
timeFrame: On days 35 and 36
measure: Fecal microbiota will be analyzed for microbial DNA
timeFrame: Days 0, 14, 35, and 49
measure: UGT1A1 activity will be analyzed
timeFrame: On days 7, 14, 42, and 49
measure: Glutathione S-transferase alpha concentration
timeFrame: On days 7, 14, 42, and 49
measure: Total cholesterol
timeFrame: On days 0, 7, 14, 35, 42, and 49
measure: LDL cholesterol
timeFrame: On days 0, 7, 14, 35, 42, and 49
measure: HDL cholesterol
timeFrame: On days 0, 7, 14, 35, 42, and 49
measure: Triacylglycerides
timeFrame: On days 0, 7, 14, 35, 42, and 49
measure: Apolipoprotein A1
timeFrame: On days 0, 7, 14, 35, 42, and 49
measure: Apolipoprotein A2
timeFrame: On days 0, 7, 14, 35, 42, and 49
measure: Apolipoprotein B
timeFrame: On days 0, 7, 14, 35, 42, and 49
measure: Changes in gene expression
timeFrame: On days 0, 14, 35, and 49
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References: