Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes

NCT03449849 | Completed

• 1 other identifier: HS60 - Kale Study
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• CYP1A2 activity will be analyzed

  Plasma will be analyzed for caffeine metabolite ratios

  Day 7

• CYP1A2 activity will be analyzed

  Plasma will be analyzed for caffeine metabolite ratios

  Day 14

• CYP1A2 activity will be analyzed

  Plasma will be analyzed for caffeine metabolite ratios

  Day 42

• CYP1A2 activity will be analyzed

  Plasma will be analyzed for caffeine metabolite ratios.

  Day 49

Secondary Outcomes (13)

• The ability of fecal microbiota to metabolize glucosinolates will be determined

  Days 14 and 49.

• Metabolites of Kale

  On days 35 and 36

• Fecal microbiota will be analyzed for microbial DNA

  Days 0, 14, 35, and 49

• UGT1A1 activity will be analyzed

  On days 7, 14, 42, and 49

• Glutathione S-transferase alpha concentration

  On days 7, 14, 42, and 49

Study Arms (2)

Base diet

OTHER

Subjects will consume a base diet prepared using traditional American foods with a macronutrient composition representative of a typical American diet.

Other: Base Diet

Kale Treatment

OTHER

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

Interventions

Base Diet OTHER

Base Diet

Base diet

Kale Treatment OTHER

Base Diet plus Kale

Kale Treatment

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead

Study Sites (1)

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Molecular Biologist

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: April 18, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)