All of our clinical studies at the present are interventions being conducted with sulforaphane- or glucoraphanin-rich broccoli sprout or seed extracts, or with commercially available supplements containing broccoli. Most of the clinical studies in which we have been and continue to be involved, are with groups of collaborators from around the world (study sites are indicated in parentheses and a list with brief descriptions and clinicaltrials.gov links follows this bulleted list). Although we are planning to initiate clinical studies with Moringa oleifera leaves, none are yet approved or funded.
- Autism Spectrum Disorder (CA, NC, NJ, MA, MA, China)
- Asthma (MD)
- Air Pollution Toxicity (China)
- Bladder Cancer (NY)
- Breast Cancer (MD, NY)
- Colon Cancer (OR)
- COPD (MD, NY, PA)
- Diesel Exhaust Particle Induced Allergic Airway Inflammation (CA)
- Drug Metabolism (WA)
- Liver Cancer (China)
- Lung Cancer (MD)
- Oral Cancer (PA)
- Parkinson’s (planning stage)
- Prostate Cancer (MD, OR, WA)
- Schizophrenia (MD)
- Skin Cancer (AZ, MD, PA, Scotland)
- Skin Erythema (MD)
- Spinal Cord Injury (veterinary; pending)
- Stomach Cancer and Helicobacter pylori Colonization (MD, Japan)
- Stability, Conversion, and Bioavailability of Oral Glucosinolates and Isothiocyanates (MD)
- X-ray Irradiation Damage (MD)
BROCCOLI / SULFORAPHANE STUDIES BY THE CULLMAN CHEMOPROTECTION CENTER AND OUR COLLABORATORS REGISTERED IN www.ClinicalTrials.gov
NCT00255775 Broccoli Sprout Extract in Preventing Lung Cancer in Smokers. [J.Brahmer, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD.] The purpose of this study is to investigate the effectiveness broccoli sprout extract has in preventing lung cancer in smokers.
NCT00621309 Sulforaphane as an Antagonist to Human PXR-mediated Drug-drug Interactions. [D.L. Eaton, University of Washington, Seattle, WA.] The purpose of this project is to determine if sulforaphane (SFN) can be used to block adverse DDIs that occur when drugs bind to and activate the PXR receptor and subsequently induce CYP3A4 activity. This project will determine whether SFN can prevent the drug Rifampin from binding to PXR and increasing CYP3A4 activity in humans following oral administration of SFN (broccoli sprout extract).
NCT00843167 Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy. [J. Shannon, Knight Cancer Institute, Oregon Health and Science University, Portland, OR.] This randomized phase II trial is studying how well broccoli sprout extract works in treating women with newly diagnosed ductal carcinoma in situ and/or atypical ductal hyperplasia.
Status: Completed, has Results
NCT00882115 Broccoli Sprout Extract Effects on Allergic Inflammation in the Nose. [A. Nel, UCLA and NIAID] The purpose of this study is to explore the effects of broccoli sprout extract on the inflammatory process in the nose caused by diesel exhaust particles, which are present in air pollution.
NCT00894712 Topical Application of Sulforaphane-containing Broccoli Sprout Extracts on Radiation Dermatitis. [R.Zellars, Johns Hopkins University, Baltimore, MD] The purpose of this study is to investigate the protective effects of topical sulforaphane-containing broccoli-sprout extracts (BSE) on radiation-induced dermatitis in women undergoing external-beam radiation therapy for breast cancer. This investigation will employ ionizing rather than ultraviolet radiation. The objective is to determine and quantify the effect of topical BSE on radiation-induced skin erythema.
Status: Completed, no Results
NCT00946309 Effects of Sulforaphane on Normal Prostate Tissue. [D.W. Lin, Fred Hutchinson Cancer Research Center, Seattle, WA] The purpose of this study is to identify the biological effects of a high-sulforaphane broccoli sprout extract in normal prostate tissue. The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract every other day will inhibit growth of prostate cancer cells.
Status: Completed, has Results
NCT00982319 Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue. [K. Visvanathan, Johns Hopkins Medical Institution, Baltimore, MD] The purpose of this research is to examine the effect of a broccoli sprout preparation on specific factors in breast tissue that are related to breast cancer risk and to assess whether sulforaphane a key component of broccoli sprouts increases the levels of protective enzymes in breast tissue. In addition, the investigators will also examine how acceptable the broccoli sprouts preparation is to the study participants.
NCT00994604 The Effects of Broccoli Sprout Extract on Obstructive Lung Disease [R. B. Brown, Johns Hopkins University, Baltimore, MD.] The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.
Status: Completed, Has Results
NCT01008826 Cross-Over Broccoli Sprouts Trial. [T.W. Kensler, Johns Hopkins University, Baltimore, MD] The study hypothesis tested is that broccoli sprouts are effective at altering the urinary levels of metabolites of the hepatocarcinogen aflatoxin B1 and of the air-borne pollutant phenanthrene in residents of Qidong, PRC, where exposures are unavoidable and high. The study will evaluate which of two formulations of broccoli sprouts beverage, glucoraphanin-rich or sulforaphane-rich, exhibits the best bioavailability and is most effective at modulating the biomarkers.
NCT01108003 Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery. [Y. Zhang, R. Pili, Roswell Park Cancer Center, Buffalo, NY] This phase I trial is studying the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery.
Status: Terminated, Has Results
NCT01228084 Sulforaphane in Treating Patients with Recurrent Prostate Cancer. [J. Alumkal, OHSU Knight Cancer Institute, Portland, OR] This phase II trial studies how well sulforaphane works in treating patients with recurrent prostate cancer. The primary objective is to determine the proportion of patients who achieve a 50% decline in prostate-specific antigen (PSA) levels within 20 weeks of sulforaphane treatment.
Status: Completed, has Results
NCT01265953 Chemoprevention of Prostate Cancer, HDAC Inhibition and DNA Methylation. [J. Shannon, Portland VA Medical Center, Portland, OR] The objective of the study is to identify mechanisms by which compounds found in cruciferous vegetables alter gene expression via epigenetic modifications (changes in gene expression) and may prevent prostate cancer development. The investigators have found that sulforaphane (SFN), an isothiocyanate found in cruciferous vegetables, inhibits histone deacetylase (HDAC) activity in human colorectal and prostate cancer cells.
NCT01335971 Broccoli Sprout Extracts Trial (BEST). [R. Wise, Johns Hopkins University, Baltimore, MD] This study will investigate whether ingestion of sulforaphane by chronic obstructive pulmonary disease (COPD) patients increases Nrf2 activity and expression of downstream antioxidants in alveolar macrophages and bronchial epithelial cells? Accordingly, the investigators are conducting a placebo-controlled randomized proof of principle trial of two oral doses of sulforaphane, 25 and 150 micromoles, for 4 weeks in 90 COPD patients. Collections of alveolar macrophages by BAL, bronchial epithelial cells by endobronchial brushings will be performed at baseline and 4 weeks. Other biospecimens will include nasal epithelial cells, PBMCs, and expired breath condensate. The goal is to establish a safe and tolerable dose of sulforaphane that effects in vivo antioxidants via Nrf2, in order to have a novel candidate treatment for longer-term efficacy trials.
Status: Completed, has results
NCT01344330 Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients. [R. Dashwood, Texas A&M University, College Station, TX] This research study will assess cruciferous vegetable intake in patients presenting for screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC) expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of cruciferous vegetable intake.
NCT01437501 Broccoli Sprout Intervention in Qidong, P.R. China. [T. W. Kensler, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD] This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships will be screened and three hundred eligible individuals will be enrolled in the study. Participants will be randomized into two treatment groups: one will receive a juice beverage containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice, lime juice, and water and the other will receive a placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide biweekly urine samples and monthly blood samples. The principal endpoints of this study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of exposure biomarkers for dietary and air-borne toxins, which are known to be high in this population.
Status: Completed, has Results
NCT01474993 Sulforaphane-rich Broccoli Sprout Extract for Autism. [A. W. Zimmerman, Lurie Autism Center, Lexington, MA] The primary objectives of this study are to answer whether there is evidence of measurable effects on social responsiveness (primary outcome) and other behavioral symptoms after treatment of autistic male adolescents and adults with orally administered sulforaphane-rich Broccoli Sprout Extract (efficacy). The secondary objectives of this study are to answer whether treatment of male adolescents and adults with autism using orally administered sulforaphane-rich Broccoli Sprout Extract within a specified dose range is safe (toxicity); treatment with sulforaphane-rich Broccoli Sprout Extract is well tolerated (side effects and adverse events); key cellular biomarkers support the hypothesized mechanisms (proof of principle).
Status: Completed, has Results
NCT01543074 Dietary Histone Deacetylase Inhibitors (HDAC). [R. Dashwood, Oregon State University, Corvallis, OR] This pilot, three-week study will help scientists understand more about how the foods people eat can modify histone deacetylases, enzymes the body produces naturally. Broccoli sprout extract and garlic oil are thought to modify these enzymes. The purpose of this study is to see if taking broccoli sprout extract alone, garlic oil alone, or broccoli sprout extract and garlic oil together, can decrease the action of histone deacetylase (HDAC) and turn on genes in white blood cells. There will be 80 people in this study.
Status: Terminated, has Results
NCT01568996 Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions. [J. Kirkwood, University of Pittsburg, Pittsburg, PA] This is a pilot study to see if oral administration of freeze dried, powdered broccoli sprouts have any effect on whether moles end up becoming melanoma.
Status: Active, not Recruiting
NCT01753908 Broccoli Sprout Extract in Treating Patients With Breast Cancer. [J. S. Young, Roswell Park Cancer Institute, Buffalo, NY] This randomized pilot trial studies broccoli sprout extract in treating patients with estrogen receptor-positive breast cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers.
NCT01845220 Prevention of Alcohol Intolerance. [P. Talalay, Johns Hopkins University, Baltimore, MD] This study is designed to determine whether Asians who are especially sensitive to alcohol exposure can be protected by boosting their activities of an alcohol disposing enzyme. This will be accomplished by administering broccoli sprouts that are rich in an agent that increases protective enzyme activity. The test system involves applying alcohol patches to the skin and measuring skin redness.
Status: Active, Not Recruiting
NCT02023931 Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa (BSE). [J. E. Bauman, University of Pittsburgh, Pittsburgh, PA] A pilot study has been designed to determine (primary objective) if three brief interventions with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway signaling, including NQO1, GSTs and AKRs, in the oral mucosa of healthy subjects. Quantitative distribution data and preliminary effect size for specific Nrf2 targets, as measured in serial buccal cell scrapings, will be determined during the course of 3-day exposures to three BSE regimens. These data will inform the design of a randomized, phase II chemoprevention trial in patients with HPV-negative HNSCC. Ten healthy volunteers will be recruited for this pilot study, Age ≥ 18 years, both male and female: 1) The non-cancer population presenting to the University of Pittsburgh Eye and Ear Institute or the Hillman Cancer Center. This may include patients with benign disease or their friends/family members, or friends/family members of patients with cancer; 2) Professionals, staff, or students at the University of Pittsburgh.
NCT02561481 Sulforaphane Treatment of Children With Autism Spectrum Disorder (ASD). [A. W. Zimmerman, University of Massachusetts, Worcester, MA]. ASD is a diverse disorder starting in early childhood and characterized by social communication impairment as well as restricted interests and repetitive behaviors. It affects 1:68 children and is an enormous medical and economic problem for which there is no established, mechanism-based treatment. Sulforaphane is an isothiocyanate derived from broccoli, and has potent activity in transcriptionally up-regulating genes that control mechanisms whereby aerobic cells protect themselves against oxidative stress, mitochondrial dysfunction, and inflammation.
This study is a clinical trial of oral sulforaphane (as broccoli seed powder) in 50 boys and girls (3-12 years) with ASD in 3 phases over 36 weeks. In Phase 1, 25 children will receive active drug and 25 will receive placebo for 15 weeks; in Phase 2, all children will receive sulforaphane from 15-30 weeks; in Phase 3, children will receive no treatment for 6 weeks. Study visits will take place at screening, 7, 15, 22, 30 and 36 weeks, when the Ohio Autism Clinical Clinical Impressions Scale – Severity and Improvement (OACIS-S and OACIS-I), Aberrant Behavior Checklist (ABC) and Social Responsiveness Scale (SRS) will be recorded. Children will be monitored with physical examinations and for toxicity with clinical laboratory studies and examine possible biomarkers: Nuclear factor-erythroid factor 2 (Nrf2), oxidative stress and mitochondrial function, the mechanistic target of rapamycin (mTOR) pathway and cytokine expression. In addition, prior to the main clinical trial, a pilot study will be carried out in 10 children with ASD, 6-12 years of age, who will receive sulforaphane, 2.2 micromoles/kg daily for 14 days. Blood and urine samples before and at the end of treatment will be collected, in order to measure several parameters that are likely to demonstrate expected effects of sulforaphane, to standardize the assays and procedures, and to determine the most effective measures.
NCT02592954 Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin. [B. Cohen, Johns Hopkins University, Baltimore, MD]. Adult participants will apply a broccoli sprout extract-jojoba oil compound to one arm every night under occlusion for 1 week. Jojoba oil alone will be applied to the other arm. At the end of 1 week, a 6mm punch biopsy will be taken from both arms and analyzed via polymerase chain reaction (PCR) and immunohistochemistry for differences in various skin proteins.
NCT02654743 Open Label of Clinical Trial of Sulforaphane in Children With Autism. [R. Hendren, University of California, San Francisco, CA] This is an open-label, 4-month study examining the effects of Sulforaphane (SF) on behavior in children with ASD and the correlation between behavior change and urinary metabolites. The goal is to determine a potential mechanism of action of SF in this population.
Status: Enrolling by Invitation
NCT02656420 Broccoli Sprout Dose Response. [T. Kensler, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD] This study will examine the extent to which lower doses of a broccoli-derived beverage enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose shown to be effective previously.
NCT02677051 Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism. [W. G. Johnson, Rutgers University, The State University of New Jersey, Piscataway, NJ ] This study is a double blind treatment trial that will test if sulforaphane improves core symptoms in autism. The investigators expect to see clinical improvement in some of these areas. Sulforaphanes come from eating certain vegetables such as broccoli. The investigators will be using a preparation that gives specific and reproducible amounts. The investigators will also test specific chemicals and genes needed for sulforaphane usage to try to understand differences in response.
NCT02800265 Bioavailability and Mucosal Bioactivity of Avmacol® in Healthy Volunteers. [J. Bauman, University of Pittsburgh, Pittsburgh, PA] Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout extracts in tablet form, hypothesized to activate protective cellular pathways including detoxication. In this study, healthy volunteers will take 3 days of Avmacol in order to evaluate both bioavailability and its bioactivity in cheek cells.
Status: Not Yet Recruiting
NCT02801448 Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes. [A. Rosengren, Lund University, Sweden] Type 2 diabetes (T2D) results from a combination of insufficient insulin secretion from pancreatic islets and insulin resistance of target cells. The investigators have extensive pre-clinical data suggesting that BSE through its high content of the isothiocyanate sulforaphane improves hepatic insulin sensitivity. BSE as a dietary supplement could therefore benefit both patients with T2D and individuals at risk for the disease. BSE-containing sulforaphane is suggested to activate Nuclear factor-like 2 (NRF2). The investigators aim to study the clinical effect of using BSE as a dietary supplement on glucose tolerance and insulin sensitivity.
Status: Active, Not Recruiting
NCT02810964 Sulforaphane to Reduce Symptoms of Schizophrenia. [F. Dickerson, Sheppard Pratt Health System, Baltimore, MD] The purpose of this study is to determine if taking a sulforaphane nutraceutical versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.
NCT02879110 A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum Disorder. [J.-J. Ou, Central South University, China] In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. Biological samples also will be collected, and stored to research related mechanisms.
NCT02880462 A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Schizophrenia. [R. Wu, Central South University, China] The goal of the study is to investigate whether adding different doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia. This study will compare the sulforaphane with placebo. There is a thirty percent change (less than half) of receiving the placebo. The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.
Status: Not Yet Recruiting
NCT02909959 Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder. [L. Politte, University of North Carolina, Chapel Hill, NC] The aim of this randomized controlled trial is to determine if a nutritional supplement containing broccoli sprout and seed extracts, a rich source of sulforaphane, is effective in reducing core symptoms of autism spectrum disorder (ASD). The study will also explore the safety and tolerability of a sulforaphane supplement in young men with ASD, as well as its effects on challenging neuropsychiatric symptoms that are commonly associated with ASD, such as hyperactivity, irritability, and repetitive movements.