Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes

Healthy Volunteers Clinical Trial

Official title:

Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03449849
• Other study ID #: HS60 - Kale Study
• Status: Completed
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: September 2018
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Base Diet
Base Diet
• Kale Treatment
Base Diet plus Kale

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	CYP1A2 activity will be analyzed	Plasma will be analyzed for caffeine metabolite ratios	Day 7
Primary	CYP1A2 activity will be analyzed	Plasma will be analyzed for caffeine metabolite ratios	Day 14
Primary	CYP1A2 activity will be analyzed	Plasma will be analyzed for caffeine metabolite ratios	Day 42
Primary	CYP1A2 activity will be analyzed	Plasma will be analyzed for caffeine metabolite ratios.	Day 49
Secondary	The ability of fecal microbiota to metabolize glucosinolates will be determined	Fecal samples will be presented with glucosinolates to determine the change in the ability of fecal microbes to metabolize the glucosinolates.	Days 14 and 49.
Secondary	Metabolites of Kale	Metabolites of Kale will be measured in plasma and urine.	On days 35 and 36
Secondary	Fecal microbiota will be analyzed for microbial DNA	Fecal microbial communities will be determined using DNA extracted from fecal samples.	Days 0, 14, 35, and 49
Secondary	UGT1A1 activity will be analyzed	Serum will be analyzed for bilirubin concentration to assess UGT1A1 activity	On days 7, 14, 42, and 49
Secondary	Glutathione S-transferase alpha concentration	Glutathione S-transferase alpha concentration will be measured in serum	On days 7, 14, 42, and 49
Secondary	Total cholesterol	Total cholesterol will be measured in serum	On days 0, 7, 14, 35, 42, and 49
Secondary	LDL cholesterol	LDL cholesterol will be measured in serum	On days 0, 7, 14, 35, 42, and 49
Secondary	HDL cholesterol	HDL cholesterol will be measured in serum	On days 0, 7, 14, 35, 42, and 49
Secondary	Triacylglycerides	Triacylglycerides will be measured in serum	On days 0, 7, 14, 35, 42, and 49
Secondary	Apolipoprotein A1	Apolipoprotein A1 will be measured in serum	On days 0, 7, 14, 35, 42, and 49
Secondary	Apolipoprotein A2	Apolipoprotein A2 will be measured in serum	On days 0, 7, 14, 35, 42, and 49
Secondary	Apolipoprotein B	Apolipoprotein B will be measured in serum	On days 0, 7, 14, 35, 42, and 49
Secondary	Changes in gene expression	messenger RNA concentrations in whole blood will be measured	On days 0, 14, 35, and 49