Healthy VolunteersNCT03013465
Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers
A study testing Base Diet with Broccoli in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial summary
The objectives of the study are 1) to determine the influence of daily consumption of well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine inflammatory marker changes consistent with decreased cancer risk. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Base Diet with Broccoli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 19 May 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non tobacco user
- Cancer Free
- Not currently taking glucosinolate/isothiocyanate containing supplements
Who cannot join
- 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 (anisinidione)
- 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)
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 objectives of the study are 1) to determine the influence of daily consumption of well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine inflammatory marker changes consistent with decreased cancer risk.
Read the detailed description
Consumption of Brassica vegetables is inversely associated with incidence of several cancers, including cancer 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 (Broccoli in particular) is their rich content of glucosinolates. Glucosinolates are sulfur-containing compounds that are converted to isothiocyanates (ITC) by an enzyme in the plant called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. The isothiocyanates are considered to be the active agent for cancer prevention. Some of the mechanisms by which isothiocyanates likely inhibit cancer include modulation of cytochrome P450 enzymes, induction of phase II enzymes, and apoptosis.
The aim of this study is to investigate how daily consumption of broccoli with myrosinase inactivated by cooking influences glucosinolate metabolism and absorption, and consequent regulation of inflammatory markers.
- Conditions
- Healthy Volunteers
- Being tested
- Control Diet, Base Diet with Broccoli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control DietOther
Also called Base Diet
Participants will receive a controlled diet with 0 g/d of broccoli. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
Base Diet with BroccoliOther
Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
| Study group | Role | What they receive |
|---|---|---|
| Control Diet | Other | Participants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of broccoli (control). Receives: Other: Control Diet |
| Brassica Diet | Active comparator | Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily. Receives: Other: Base Diet with Broccoli |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in glucosinolate metabolites will be measured in blood plasma and urine
To track the change of endogenous broccoli isothiocyanates in this crossover study, glucosinolate metabolites will be measured in both blood plasma and urine
Measured: At end of diet period 1 (week 3) and at the end of diet period 2 (week 12)
Secondary outcomes (5)
Body composition will be determined by dual energy x-ray absorptiometry (DEXA)
Determine fat, lean, and bone mineral mass, and visceral fat deposition in our subjects
Measured: Day 0, just prior to beginning the controlled diet
The ability of fecal microbiota to metabolize glucosinolates will be determined
Fecal samples will be presented with glucoraphanin to determine the ability of fecal microbes to metabolize it
Measured: once per week during diet periods 1 and 2 (weeks 1, 2, 3, 10, 11, and 12)
Fecal microbiota will be analyzed for microbial DNA
Fecal microbial communities will be determined using DNA extracted from fecal samples
Measured: once at the beginning and end of diet periods 1 and 2 (weeks 1, 3, 10, and 12)
Markers of gut health will be analyzed in blood
Zonulin in blood serum will be measured by ELISA
Measured: once in the third week of diet periods 1 and 2 (weeks 3 and 12)
Markers of inflammation will be measured in blood
Cytokines and acute phase proteins will be measured in blood
Measured: at end of diet period 1 (week 3) and at end of diet period 2 (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start27 Feb 2017
- Primary completion19 May 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 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
- NCT03013465
- Sponsor's protocol ID
- HS55
- Status last verified
- May 2017
- First submitted
- 19 Dec 2016
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charron CS, Vinyard BT, Jeffery EH, Ross SA, Seifried HE, Novotny JA. BMI Is Associated With Increased Plasma and Urine Appearance of Glucosinolate Metabolites After Consumption of Cooked Broccoli. Front Nutr. 2020 Sep 24;7:575092. doi: 10.3389/fnut.2020.575092. eCollection 2020.
PubMed 33072799
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers
- ClinicalTrials.gov ID
- NCT03013465
- Acronym / sponsor ID
- HS55
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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 objectives of the study are 1) to determine the influence of daily consumption of well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine inflammatory marker changes consistent with decreased cancer risk.
Detailed description
Consumption of Brassica vegetables is inversely associated with incidence of several cancers, including cancer 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 (Broccoli in particular) is their rich content of glucosinolates. Glucosinolates are sulfur-containing compounds that are converted to isothiocyanates (ITC) by an enzyme in the plant called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. The isothiocyanates are considered to be the active agent for cancer prevention. Some of the mechanisms by which isothiocyanates likely inhibit cancer include modulation of cytochrome P450 enzymes, induction of phase II enzymes, and apoptosis.
The aim of this study is to investigate how daily consumption of broccoli with myrosinase inactivated by cooking influences glucosinolate metabolism and absorption, and consequent regulation of inflammatory markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Diet | Other | Other: Control DietParticipants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of broccoli (control). |
| Brassica Diet | Active comparator | Other: Base Diet with BroccoliParticipants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non tobacco user
- Cancer Free
- Not currently taking glucosinolate/isothiocyanate containing supplements
Key exclusion criteria (7 listed)
- 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 (anisinidione)
- History of bariatric surgery or nutrient malabsorption disease
- Pregnant, lactating, or intending to become pregnant during the study period
- Crohn's disease or diverticulitis
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 |
|---|---|---|
| Control DietAlso: Base DietParticipants will receive a controlled diet with 0 g/d of broccoli. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. | Other | Control Diet |
| Base Diet with BroccoliParticipants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. | Other | Brassica Diet |
Primary outcome
The change in glucosinolate metabolites will be measured in blood plasma and urine
Time frame: At end of diet period 1 (week 3) and at the end of diet period 2 (week 12)
To track the change of endogenous broccoli isothiocyanates in this crossover study, glucosinolate metabolites will be measured in both blood plasma and urine
5 secondary outcomes
Body composition will be determined by dual energy x-ray absorptiometry (DEXA)
Time frame: Day 0, just prior to beginning the controlled diet
The ability of fecal microbiota to metabolize glucosinolates will be determined
Time frame: once per week during diet periods 1 and 2 (weeks 1, 2, 3, 10, 11, and 12)
Fecal microbiota will be analyzed for microbial DNA
Time frame: once at the beginning and end of diet periods 1 and 2 (weeks 1, 3, 10, and 12)
Markers of gut health will be analyzed in blood
Time frame: once in the third week of diet periods 1 and 2 (weeks 3 and 12)
Markers of inflammation will be measured in blood
Time frame: at end of diet period 1 (week 3) and at end of diet period 2 (week 12)
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 25 May 2017.
- Derived from this study: PubMed 33072799Charron CS, Vinyard BT, Jeffery EH, Ross SA, Seifried HE, Novotny JA. BMI Is Associated With Increased Plasma and Urine Appearance of Glucosinolate Metabolites After Consumption of Cooked Broccoli. Front Nutr. 2020 Sep 24;7:575092. doi: 10.3389/fnut.2020.575092. eCollection 2020.
- Individual participant dataSharing planned: No
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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 with Broccoli 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 3 inclusion and 7 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 25 May 2017. 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?
The change in glucosinolate metabolites will be measured in blood plasma and urine (time frame: At end of diet period 1 (week 3) and at the end of diet period 2 (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03013465, which also lists 1 linked publication.
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 25 May 2017.