Healthy VolunteersNCT03773497
Bioavailability of Phytonutrients From Novel Preparations of Broccoli
A study testing Common Snack Combination, Cheesy Broccoli Snack and Cheesy Broccoli with Daikon Radish Snack 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 the effects of different methods of broccoli preparation on levels of urinary glucosinolate metabolites. The secondary objective is to determine the effects of different methods of broccoli preparation on levels of plasma carotenoids. 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?
- Common Snack Combination, Cheesy Broccoli Snack and Cheesy Broccoli with Daikon Radish Snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 28 Jun 2019
- 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
- Between 21 and 75 years old at beginning of study
Who cannot join
- Pregnant, lactating, or intending to become pregnant during the study period
- Women who have given birth during the previous 12 months
- Presence of kidney disease, liver disease, gout, certain cancers, gastrointestinal disease, hyperthyroidism, untreated or unstable hypothyroidism, pancreatic disease, other metabolic diseases, or malabsorption syndromes requiring special diets
- History of certain cancers within last 3 years
- Known allergy or intolerance to Brassica vegetables
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low-fat diets, high-protein diets)
Show all 17Show fewer
- Colonoscopy during three weeks prior to start of study
- Unwillingness to abstain from probiotics or vitamin, mineral, herbal and glucosinolate/isothiocyanate supplements for two weeks prior to the study and during the study
- Use of tobacco products within 6 months preceding study
- Crohn's disease or diverticulitis
- Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
- Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
- Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
- Fasting glucose greater than or equal to 126 mg/dL
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
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 the effects of different methods of broccoli preparation on levels of urinary glucosinolate metabolites. The secondary objective is to determine the effects of different methods of broccoli preparation on levels of plasma carotenoids.
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 including glucosinolates and carotenoids. Glucosinolates are sulfur-containing compounds that are converted to bioactive metabolites by an enzyme called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. These bioactive compounds are considered to be active agents 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. Carotenoids may also have a role in cancer prevention and other health benefits including reducing age-related macular degeneration, and therefore merit research to reveal factors that affect their presence in the body.
The primary aim of this study is to investigate how various preparations of broccoli impact levels of these healthful nutrients in humans.
- Conditions
- Healthy Volunteers
- Being tested
- Common Snack Combination, Cheesy Broccoli Snack, Cheesy Broccoli with Daikon Radish Snack, Uncooked Broccoli Snack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common Snack CombinationOther
Combination of Chips, Pretzels, and Popcorn.
Cheesy Broccoli SnackOther
Oven-roasted, freeze-dried, cheese flavored broccoli
Cheesy Broccoli with Daikon Radish SnackOther
Oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder
Uncooked Broccoli SnackOther
Uncooked, freeze-dried broccoli with ranch-type dip
| Study group | Role | What they receive |
|---|---|---|
| Common snack combination | Other | Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of a combination of common snack foods (pretzels, potato chips, and popcorn). Receives: Other: Common Snack Combination |
| Cheese broccoli | Other | Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli. Receives: Other: Cheesy Broccoli Snack |
| Cheese broccoli with Daikon radish powder | Other | Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder. Receives: Other: Cheesy Broccoli with Daikon Radish Snack |
| Uncooked broccoli with ranch-type dip | Other | Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of uncooked, freeze-dried broccoli with ranch-type dip. Receives: Other: Uncooked Broccoli Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucosinolate Metabolites will be measured
Urine will be analyzed for glucosinolate metabolites
Measured: Day 1
Glucosinolate Metabolites will be measured
Urine will be analyzed for glucosinolate metabolites
Measured: Day 22
Glucosinolate Metabolites will be measured
Urine will be analyzed for glucosinolate metabolites
Measured: Day 43
Glucosinolate Metabolites will be measured
Urine will be analyzed for glucosinolate metabolites
Measured: Day 64
Secondary outcomes (1)
Carotenoids will be measured
Carotenoids will be extracted from plasma
Measured: Days 1, 2, 3, 4, 11, 22, 23, 24, 25, 32, 43, 44, 45, 46, 53, 64, 65, 66, 67, 74
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start16 Apr 2019
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
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
- 16 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
- NCT03773497
- Sponsor's protocol ID
- HS63 - Broccoli Snack Study
- Status last verified
- Aug 2019
- First submitted
- 10 Dec 2018
- Last updated
- 3 Sep 2019
- 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 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Phytonutrients From Novel Preparations of Broccoli
- ClinicalTrials.gov ID
- NCT03773497
- Acronym / sponsor ID
- HS63 - Broccoli Snack Study
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 12 Dec 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 the effects of different methods of broccoli preparation on levels of urinary glucosinolate metabolites. The secondary objective is to determine the effects of different methods of broccoli preparation on levels of plasma carotenoids.
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 including glucosinolates and carotenoids. Glucosinolates are sulfur-containing compounds that are converted to bioactive metabolites by an enzyme called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. These bioactive compounds are considered to be active agents 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. Carotenoids may also have a role in cancer prevention and other health benefits including reducing age-related macular degeneration, and therefore merit research to reveal factors that affect their presence in the body.
The primary aim of this study is to investigate how various preparations of broccoli impact levels of these healthful nutrients in humans.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Common snack combination | Other | Other: Common Snack CombinationSubjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of a combination of common snack foods (pretzels, potato chips, and popcorn). |
| Cheese broccoli | Other | Other: Cheesy Broccoli SnackSubjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli. |
| Cheese broccoli with Daikon radish powder | Other | Other: Cheesy Broccoli with Daikon Radish SnackSubjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder. |
| Uncooked broccoli with ranch-type dip | Other | Other: Uncooked Broccoli SnackSubjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of uncooked, freeze-dried broccoli with ranch-type dip. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Between 21 and 75 years old at beginning of study
Key exclusion criteria (17 listed)
- Pregnant, lactating, or intending to become pregnant during the study period
- Women who have given birth during the previous 12 months
- Presence of kidney disease, liver disease, gout, certain cancers, gastrointestinal disease, hyperthyroidism, untreated or unstable hypothyroidism, pancreatic disease, other metabolic diseases, or malabsorption syndromes requiring special diets
- History of certain cancers within last 3 years
- Known allergy or intolerance to Brassica vegetables
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 |
|---|---|---|
| Common Snack CombinationCombination of Chips, Pretzels, and Popcorn. | Other | Common snack combination |
| Cheesy Broccoli SnackOven-roasted, freeze-dried, cheese flavored broccoli | Other | Cheese broccoli |
| Cheesy Broccoli with Daikon Radish SnackOven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder | Other | Cheese broccoli with Daikon radish powder |
| Uncooked Broccoli SnackUncooked, freeze-dried broccoli with ranch-type dip | Other | Uncooked broccoli with ranch-type dip |
Primary outcome
Glucosinolate Metabolites will be measured
Time frame: Day 1
Urine will be analyzed for glucosinolate metabolites
Glucosinolate Metabolites will be measured
Time frame: Day 22
Urine will be analyzed for glucosinolate metabolites
Glucosinolate Metabolites will be measured
Time frame: Day 43
Urine will be analyzed for glucosinolate metabolites
Glucosinolate Metabolites will be measured
Time frame: Day 64
Urine will be analyzed for glucosinolate metabolites
1 secondary outcome
Carotenoids will be measured
Time frame: Days 1, 2, 3, 4, 11, 22, 23, 24, 25, 32, 43, 44, 45, 46, 53, 64, 65, 66, 67, 74
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 3 Sep 2019.
- 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 Common Snack Combination, Cheesy Broccoli Snack and Cheesy Broccoli with Daikon Radish Snack 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 1 inclusion and 17 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 3 Sep 2019. 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?
Glucosinolate Metabolites will be measured (time frame: Day 1). 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 3 Sep 2019.