Healthy VolunteersNCT03449849
Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes
A study testing Base Diet and Kale Treatment in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Base Diet and Kale Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2018to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Base Diet, Kale Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Base DietOther
Base Diet
Kale TreatmentOther
Base Diet plus Kale
| Study group | Role | What they receive |
|---|---|---|
| Base diet | Other | Subjects will consume a base diet prepared using traditional American foods with a macronutrient composition representative of a typical American diet. Receives: 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. Receives: Other: Kale Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
CYP1A2 activity will be analyzed
Plasma will be analyzed for caffeine metabolite ratios
Measured: Day 7
CYP1A2 activity will be analyzed
Plasma will be analyzed for caffeine metabolite ratios
Measured: Day 14
CYP1A2 activity will be analyzed
Plasma will be analyzed for caffeine metabolite ratios
Measured: Day 42
CYP1A2 activity will be analyzed
Plasma will be analyzed for caffeine metabolite ratios.
Measured: Day 49
Secondary outcomes (13)
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.
Measured: Days 14 and 49.
Metabolites of Kale
Metabolites of Kale will be measured in plasma and urine.
Measured: On days 35 and 36
Fecal microbiota will be analyzed for microbial DNA
Fecal microbial communities will be determined using DNA extracted from fecal samples.
Measured: Days 0, 14, 35, and 49
UGT1A1 activity will be analyzed
Serum will be analyzed for bilirubin concentration to assess UGT1A1 activity
Measured: On days 7, 14, 42, and 49
Glutathione S-transferase alpha concentration
Glutathione S-transferase alpha concentration will be measured in serum
Measured: On days 7, 14, 42, and 49
Total cholesterol
Total cholesterol will be measured in serum
Measured: On days 0, 7, 14, 35, 42, and 49
LDL cholesterol
LDL cholesterol will be measured in serum
Measured: On days 0, 7, 14, 35, 42, and 49
HDL cholesterol
HDL cholesterol will be measured in serum
Measured: On days 0, 7, 14, 35, 42, and 49
Triacylglycerides
Triacylglycerides will be measured in serum
Measured: On days 0, 7, 14, 35, 42, and 49
Apolipoprotein A1
Apolipoprotein A1 will be measured in serum
Measured: On days 0, 7, 14, 35, 42, and 49
Apolipoprotein A2
Apolipoprotein A2 will be measured in serum
Measured: On days 0, 7, 14, 35, 42, and 49
Apolipoprotein B
Apolipoprotein B will be measured in serum
Measured: On days 0, 7, 14, 35, 42, and 49
Changes in gene expression
messenger RNA concentrations in whole blood will be measured
Measured: On days 0, 14, 35, and 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start18 Apr 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Craig Charron, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449849
- Sponsor's protocol ID
- HS60 - Kale Study
- Status last verified
- Sep 2018
- First submitted
- 22 Feb 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes
- ClinicalTrials.gov ID
- NCT03449849
- Acronym / sponsor ID
- HS60 - Kale Study
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Base diet | Other | Other: Base DietSubjects will consume a base diet prepared using traditional American foods with a macronutrient composition representative of a typical American diet. |
| Kale Treatment | Other | Other: Kale TreatmentSubjects will consume 500 g of kale per 2000 kcal of food, split between breakfast and dinner, as a supplement to the base diet. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Base DietBase Diet | Other | Base diet |
| Kale TreatmentBase Diet plus Kale | Other | Kale Treatment |
Primary outcome
CYP1A2 activity will be analyzed
Time frame: Day 7
Plasma will be analyzed for caffeine metabolite ratios
CYP1A2 activity will be analyzed
Time frame: Day 14
Plasma will be analyzed for caffeine metabolite ratios
CYP1A2 activity will be analyzed
Time frame: Day 42
Plasma will be analyzed for caffeine metabolite ratios
CYP1A2 activity will be analyzed
Time frame: Day 49
Plasma will be analyzed for caffeine metabolite ratios.
13 secondary outcomes
The ability of fecal microbiota to metabolize glucosinolates will be determined
Time frame: Days 14 and 49.
Metabolites of Kale
Time frame: On days 35 and 36
Fecal microbiota will be analyzed for microbial DNA
Time frame: Days 0, 14, 35, and 49
UGT1A1 activity will be analyzed
Time frame: On days 7, 14, 42, and 49
Glutathione S-transferase alpha concentration
Time frame: On days 7, 14, 42, and 49
Total cholesterol
Time frame: On days 0, 7, 14, 35, 42, and 49
LDL cholesterol
Time frame: On days 0, 7, 14, 35, 42, and 49
HDL cholesterol
Time frame: On days 0, 7, 14, 35, 42, and 49
Triacylglycerides
Time frame: On days 0, 7, 14, 35, 42, and 49
Apolipoprotein A1
Time frame: On days 0, 7, 14, 35, 42, and 49
Apolipoprotein A2
Time frame: On days 0, 7, 14, 35, 42, and 49
Apolipoprotein B
Time frame: On days 0, 7, 14, 35, 42, and 49
Changes in gene expression
Time frame: On days 0, 14, 35, and 49
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Base Diet and Kale Treatment in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CYP1A2 activity will be analyzed (time frame: Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.