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Completed

NCT Number: NCT03449849

Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes

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.

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Key information

Conditions

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Base Diet

Other

Base Diet

Kale Treatment

Other

Base Diet plus Kale

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 28, 2018
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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