USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705, United States
NCT Number: NCT03449849
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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Notify Me21 year–75 year
All sexes
Interventional
Not applicable
Beltsville, Maryland, 20705, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Base Diet
Base Diet plus Kale
Time frame: Day 7
Plasma will be analyzed for caffeine metabolite ratios
Time frame: Day 14
Plasma will be analyzed for caffeine metabolite ratios
Time frame: Day 42
Plasma will be analyzed for caffeine metabolite ratios
Time frame: Day 49
Plasma will be analyzed for caffeine metabolite ratios.
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.
Time frame: On days 35 and 36
Metabolites of Kale will be measured in plasma and urine.
Time frame: Days 0, 14, 35, and 49
Fecal microbial communities will be determined using DNA extracted from fecal samples.
Time frame: On days 7, 14, 42, and 49
Serum will be analyzed for bilirubin concentration to assess UGT1A1 activity
Time frame: On days 7, 14, 42, and 49
Glutathione S-transferase alpha concentration will be measured in serum
Time frame: On days 0, 7, 14, 35, 42, and 49
Total cholesterol will be measured in serum
Time frame: On days 0, 7, 14, 35, 42, and 49
LDL cholesterol will be measured in serum
Time frame: On days 0, 7, 14, 35, 42, and 49
HDL cholesterol will be measured in serum
Time frame: On days 0, 7, 14, 35, 42, and 49
Triacylglycerides will be measured in serum
Time frame: On days 0, 7, 14, 35, 42, and 49
Apolipoprotein A1 will be measured in serum
Time frame: On days 0, 7, 14, 35, 42, and 49
Apolipoprotein A2 will be measured in serum
Time frame: On days 0, 7, 14, 35, 42, and 49
Apolipoprotein B will be measured in serum
Time frame: On days 0, 14, 35, and 49
messenger RNA concentrations in whole blood will be measured
USDA Beltsville Human Nutrition Research Center
Fed
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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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