Dietary ModificationNCT01726127
Green Vegetables and Women's Health
A study testing Broccoli and Brussels Sprouts and Cruciferous Complete in people with Dietary Modification, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups fruits and vegetables daily. However, at current intake levels, fruit consumption will have to improve by more than 100% and vegetable intake by 50% to meet this recommendation. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Broccoli and Brussels Sprouts and Cruciferous Complete
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Sep 2015
- 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 40 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women between the ages of 40-50; premenopause is defined as regular menstrual cycles every 23-35 days
- Willing to be randomized and compliant to the 3 study groups (whole cruciferous vegetable intake, cruciferous supplement or placebo capsules)
- Able to give informed consent.
Who cannot join
- Urinary 2:16 > or = 3.
- Current kidney or liver disease, adrenalectomy, or oophorectomy.
- Use of tobacco products within the preceding three months, illegal use of medications or use of illegal drugs or substances.
- Current use of antibiotics, cimetidine or black cohosh.
- Systemic administration of estrogen, or use of non-prescription hormones, tamoxifen, or diabetes medication within the last three months.
- Women under a physician-directed diet or those with a strong dislike of Brassica vegetables.
- Presence of cancer in the last 5 years, with the exception of fully resected basal or squamous cell tumors.
- Participation in an investigational drug study in the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Osteoporosis Clinical Research Program Clinic
Madison, Wisconsin, 53705
About this study
Official title: Effect of Cruciferous Vegetables or a Cruciferous Supplement on Urinary Estrogen Metabolites in Premenopausal Women
The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups fruits and vegetables daily. However, at current intake levels, fruit consumption will have to improve by more than 100% and vegetable intake by 50% to meet this recommendation. Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes are not considered. It is possible that improved fruit and vegetable intake will have beneficial health effects. For example, higher intakes of fruits and vegetables, and particularly cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.), are associated with lower rates of many degenerative diseases, including some cancers, yet this group of vegetables may continue to be under-consumed due to their strong flavors. A supplement made from these vegetables (Cruciferous CompleteTM made by Standard Process Inc. Palmyra, WI) contains a group of phytochemicals called glucosinolates that can shift estrogen metabolism in a favorable way. One proposed biomarker of chemoprotection from breast cancer is the urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16). In the main study, the effects of cruciferous vegetables (broccoli or Brussels sprouts), Cruciferous CompleteTM whole food supplements, or placebos on this ratio of urinary estrogen metabolites in healthy premenopausal women will be compared over an eight-week period. The investigators hypothesize that treatment with daily supplements will increase the 2:16 ratio as compared to daily consumption of a combination of Brussels sprouts and broccoli or a placebo, suggesting reduced breast cancer risk.
In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin, lutein and lycopene with dietary carotenoid intake as measured by a food frequency questionnaire and body composition will be evaluated in healthy premenopausal women. Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues and their concentration in human blood reflects dietary intake of carotenoid-rich foods. Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual status, but are inversely associated with body fatness. Thus, serum carotenoid concentrations may serve as a functional marker for chronic disease risk associated with excess body fat.
- Conditions
- Dietary Modification
- Being tested
- Broccoli and Brussels Sprouts, Cruciferous Complete, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli and Brussels SproutsOther
Cruciferous CompleteDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Broccoli and Brussels Sprouts | Experimental | Subjects will consume broccoli or Brussels sprouts (40g daily) for 8 weeks. Receives: Other: Broccoli and Brussels Sprouts |
| Cruciferous Complete | Experimental | Subjects will take Cruciferous CompleteTM supplements (2 capsules, 3 times daily) for 8 weeks. Receives: Dietary Supplement: Cruciferous Complete |
| Placebo | Placebo comparator | Subjects will take placebo capsules (2 capsules, 3 times daily) for 8 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary 2:16 ratio
Urinary 2:16 ratios between treatment groups.
Measured: 8 weeks
Secondary outcomes (1)
Urinary 4OHE1 and 4OHE2
Urinary concentrations of 4-hydroxyestrone (4OHE1) and 4-hydroxyestradiol (4OHE2) between treatment groups.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Standard Process Inc.
- Responsible party
- Sponsor
- Investigators
- Sherry A. Tanumihardjo, PhD, Principal investigator, University of Wisconsin, MadisonNeil Binkley, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726127
- Sponsor's protocol ID
- 2011-0872
- Status last verified
- Oct 2015
- First submitted
- 2 Nov 2012
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cruciferous Vegetables or a Cruciferous Supplement on Urinary Estrogen Metabolites in Premenopausal Women
- ClinicalTrials.gov ID
- NCT01726127
- Acronym / sponsor ID
- 2011-0872
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Standard Process Inc.
- Study start
- Nov 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Nov 2012 (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 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups fruits and vegetables daily. However, at current intake levels, fruit consumption will have to improve by more than 100% and vegetable intake by 50% to meet this recommendation. Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes are not considered. It is possible that improved fruit and vegetable intake will have beneficial health effects. For example, higher intakes of fruits and vegetables, and particularly cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.), are associated with lower rates of many degenerative diseases, including some cancers, yet this group of vegetables may continue to be under-consumed due to their strong flavors. A supplement made from these vegetables (Cruciferous CompleteTM made by Standard Process Inc. Palmyra, WI) contains a group of phytochemicals called glucosinolates that can shift estrogen metabolism in a favorable way. One proposed biomarker of chemoprotection from breast cancer is the urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16). In the main study, the effects of cruciferous vegetables (broccoli or Brussels sprouts), Cruciferous CompleteTM whole food supplements, or placebos on this ratio of urinary estrogen metabolites in healthy premenopausal women will be compared over an eight-week period. The investigators hypothesize that treatment with daily supplements will increase the 2:16 ratio as compared to daily consumption of a combination of Brussels sprouts and broccoli or a placebo, suggesting reduced breast cancer risk.
In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin, lutein and lycopene with dietary carotenoid intake as measured by a food frequency questionnaire and body composition will be evaluated in healthy premenopausal women. Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues and their concentration in human blood reflects dietary intake of carotenoid-rich foods. Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual status, but are inversely associated with body fatness. Thus, serum carotenoid concentrations may serve as a functional marker for chronic disease risk associated with excess body fat.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Broccoli and Brussels Sprouts | Experimental | Other: Broccoli and Brussels SproutsSubjects will consume broccoli or Brussels sprouts (40g daily) for 8 weeks. |
| Cruciferous Complete | Experimental | Dietary Supplement: Cruciferous CompleteSubjects will take Cruciferous CompleteTM supplements (2 capsules, 3 times daily) for 8 weeks. |
| Placebo | Placebo comparator | Other: PlaceboSubjects will take placebo capsules (2 capsules, 3 times daily) for 8 weeks. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenopausal women between the ages of 40-50; premenopause is defined as regular menstrual cycles every 23-35 days
- Willing to be randomized and compliant to the 3 study groups (whole cruciferous vegetable intake, cruciferous supplement or placebo capsules)
- Able to give informed consent.
Key exclusion criteria (8 listed)
- Urinary 2:16 > or = 3.
- Current kidney or liver disease, adrenalectomy, or oophorectomy.
- Use of tobacco products within the preceding three months, illegal use of medications or use of illegal drugs or substances.
- Current use of antibiotics, cimetidine or black cohosh.
- Systemic administration of estrogen, or use of non-prescription hormones, tamoxifen, or diabetes medication within the last three months.
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 |
|---|---|---|
| Broccoli and Brussels Sprouts | Other | Broccoli and Brussels Sprouts |
| Cruciferous Complete | Dietary supplement | Cruciferous Complete |
| Placebo | Other | Placebo |
Primary outcome
Urinary 2:16 ratio
Time frame: 8 weeks
Urinary 2:16 ratios between treatment groups.
1 secondary outcome
Urinary 4OHE1 and 4OHE2
Time frame: 8 weeks
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 7 Oct 2015.
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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.
Sherry A. Tanumihardjo, PhD principal investigator
University of Wisconsin, Madison
Neil Binkley, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broccoli and Brussels Sprouts and Cruciferous Complete in people with Dietary Modification, run by University of Wisconsin, Madison 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 8 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 7 Oct 2015. 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. Some participants in this study may receive a placebo. 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?
Urinary 2:16 ratio (time frame: 8 weeks). 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 7 Oct 2015.