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Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03449849
Recruitment Status : Completed
First Posted : February 28, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Craig Charron, USDA Beltsville Human Nutrition Research Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Base Diet Other: Kale Treatment Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018
Arms and Interventions
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Arm Intervention/treatment
Base diet
Subjects will consume a base diet prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
 Other: Base Diet
Base Diet
Kale Treatment
Subjects will consume 500 g of kale per 2000 kcal of food, split between breakfast and dinner, as a supplement to the base diet.
 Other: Kale Treatment
Base Diet plus Kale


Outcome Measures
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Primary Outcome Measures :
  1. CYP1A2 activity will be analyzed [ Time Frame: Day 7 ]
    Plasma will be analyzed for caffeine metabolite ratios

  2. CYP1A2 activity will be analyzed [ Time Frame: Day 14 ]
    Plasma will be analyzed for caffeine metabolite ratios

  3. CYP1A2 activity will be analyzed [ Time Frame: Day 42 ]
    Plasma will be analyzed for caffeine metabolite ratios

  4. CYP1A2 activity will be analyzed [ Time Frame: Day 49 ]
    Plasma will be analyzed for caffeine metabolite ratios.


Secondary Outcome Measures :
  1. The ability of fecal microbiota to metabolize glucosinolates will be determined [ Time Frame: Days 14 and 49. ]
    Fecal samples will be presented with glucosinolates to determine the change in the ability of fecal microbes to metabolize the glucosinolates.

  2. Metabolites of Kale [ Time Frame: On days 35 and 36 ]
    Metabolites of Kale will be measured in plasma and urine.

  3. Fecal microbiota will be analyzed for microbial DNA [ Time Frame: Days 0, 14, 35, and 49 ]
    Fecal microbial communities will be determined using DNA extracted from fecal samples.

  4. UGT1A1 activity will be analyzed [ Time Frame: On days 7, 14, 42, and 49 ]
    Serum will be analyzed for bilirubin concentration to assess UGT1A1 activity

  5. Glutathione S-transferase alpha concentration [ Time Frame: On days 7, 14, 42, and 49 ]
    Glutathione S-transferase alpha concentration will be measured in serum

  6. Total cholesterol [ Time Frame: On days 0, 7, 14, 35, 42, and 49 ]
    Total cholesterol will be measured in serum

  7. LDL cholesterol [ Time Frame: On days 0, 7, 14, 35, 42, and 49 ]
    LDL cholesterol will be measured in serum

  8. HDL cholesterol [ Time Frame: On days 0, 7, 14, 35, 42, and 49 ]
    HDL cholesterol will be measured in serum

  9. Triacylglycerides [ Time Frame: On days 0, 7, 14, 35, 42, and 49 ]
    Triacylglycerides will be measured in serum

  10. Apolipoprotein A1 [ Time Frame: On days 0, 7, 14, 35, 42, and 49 ]
    Apolipoprotein A1 will be measured in serum

  11. Apolipoprotein A2 [ Time Frame: On days 0, 7, 14, 35, 42, and 49 ]
    Apolipoprotein A2 will be measured in serum

  12. Apolipoprotein B [ Time Frame: On days 0, 7, 14, 35, 42, and 49 ]
    Apolipoprotein B will be measured in serum

  13. Changes in gene expression [ Time Frame: On days 0, 14, 35, and 49 ]
    messenger RNA concentrations in whole blood will be measured


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449849


Locations
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United States, Maryland
USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
More Information
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Responsible Party: Craig Charron, Research Molecular Biologist, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT03449849    
Other Study ID Numbers: HS60 - Kale Study
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No