www.ClinicalTrials.govREGISTERED BROCCOLI / SULFORAPHANE STUDIES WITH WHICH THE CULLMAN CHEMOPROTECTION CENTER IS NOT INVOLVED

 

NCT00252018  The Effect of Broccoli Sprouts as a Nutritional Supplement in the Prevention of Cardiovascular Disease. [C. Torp-Pedersen, Department of Cardiology, Bispebjerg Hospital, Denmark] The purpose of this study is to investigate whether a daily intake of dried broccoli sprouts will improve the endothelial function of the participants as measured by Flow mediated dilation (FMD). The dried sprouts are chosen because broccoli sprouts are known as containing large amounts of the glucosinolate glucoraphanin which in vitro and in animal models has been shown to have a positive effect on the endothelium as measured by NO release.

Status: Completed

NCT00340743  Diet and Genetic Damage. [J. Taylor, University of North Carolina, Chapel Hill, NC]  This study will examine the risks and protective effects of dietary factors on temporary genetic damage to cells lining the gastrointestinal tract and to blood cells. Some foods, including very well done meat, may increase genetic damage in cells, while others, such as yogurt and vegetables, may reduce genetic damage. This study may provide new information on the influence of diet on increasing or decreasing the risk of developing cancer, particularly colorectal cancer. The study is conducted at the General Clinical Research Center (GCRC) of the University of North Carolina.

Status: Completed

 

NCT00535977  Broccoli, Peas and PIN [R. F. Mithen, Institute of Food Research, Norwich, Norfolk, United Kingdom]. Cancer is one of the main causes of death among humans in the world. Prostate cancer affects 20,000 men in the UK alone each year. Diet is known to be a major factor that influences risk of cancer. Therefore, changes to the diet may alter cancer risk. Cruciferous vegetables, particularly broccoli, provide the diet with a substantial source of plant chemicals called glucosinolates. Previous research has indicated that glucosinolates break down to form isothiocyanates (ITCs) that can be absorbed in the body. Further research has indicated that ITCs may protect the body against the development of prostate cancer. However, the mechanisms behind this effect are not fully understood.

Status: Completed

 

NCT00607932  Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer. [J. H. Fowke, Vanderbilt University, Nashville, TN]   Eating a diet high in vegetables may lower the risk of some types of cancer. Brassica vegetables (such as cabbages, kale, broccoli, Brussels sprouts, and cauliflower) and indole-3-carbinol (a substance found in cruciferous vegetables) may help lower the risk of prostate cancer recurrence. This randomized clinical trial is studying the side effects and how well Brassica vegetables work compared with indole-3-carbinol in treating patients with PSA recurrence after surgery for prostate cancer.

Status: Completed

 

NCT01114399  Diet and Vascular Health Study. [Institute of Food Research, Norwich, Norfolk, United Kingdom] The aim of this study is to examine the effects of a diet rich in broccoli on cardiovascular disease risk using biochemical indicators such as blood lipid profiles, most notably cholesterol; markers of inflammation as well as established physiological measurements such as Pulse wave velocity (PWV), Augmentation index (AIx) and Ambulatory Blood Pressure Measurements (ABPM).

Status: Completed

 

NCT01129466  Effects of 2 Different Broccoli Sprout Containing Supplements on Nasal Cells in Healthy Volunteers (Broccosprout).  [T. Noah, University of North Carolina, Chapel Hill, NC]  To compare the change in nasal cell HO-1 expression induced by two different preparations of sulforaphane (SFN)-containing nutritional supplements. In this pilot study, subjects will be randomized to receive either the equivalent of 4 ounces/day of fresh broccoli sprouts in food and tea, or the equivalent amount as broccoli sprout homogenates, for 3 consecutive days. Nasal lavage and blood samples will be obtained before, during and after this 3-day period. After at least a 2-week washout interval, the protocol will be repeated with the alternate supplement, in a crossover design. The primary analysis will test the hypothesis that broccoli sprouts in food will increase HO-1 expression to a similar degree as the equivalent amount of sprouts in homogenates.

Status: Completed

 

NCT01183923  Dietary Interventions in Asthma Treatment: Sprouts Study. [E. Matsui, Johns Hopkins University, Baltimore, MD]  The main objectives are to test the effect of broccoli sprouts (BS) on biomarkers of oxidative stress (OS), inflammation, basophil activation, and clinical outcomes in mouse allergen-induced asthma by: (1) determining if BS improves lung function and airways symptom responses in mouse-sensitized adults with asthma undergoing environmental mouse allergen challenge (EMAC), (2) examining the effect of BS on OS, inflammation, and basophil activation, and (3) examining the effect of BS on changes in OS, inflammation, and basophil activation after EMAC.

Status: Suspended

 

NCT01269723  Effects of Sulforaphane (SFN) on Immune Response to Live Attenuated Influenza Virus in Smokers and Nonsmokers.  [T. Noah, University of North Carolina, Chapel Hill, NC]  The purpose is to learn about short term responses to live attenuated influenza virus (LAIV, administered via Flumist® vaccine) between smoking and nonsmoking volunteers treated with broccoli sprout homogenates (“shake”) or a placebo homogenate. Subjects will be seen for a screening visit (inc. HIV test) and then randomly assigned to receive 1 of 2 homogenates. Nasal lavage (NL), blood samples and nasal biopsies will performed prior to and after study interventions.

Status: Completed

 

NCT01315665  Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation. [JF Chmiel, Rainbow Babies and Children’s Hospital, Cleveland, OH]  The purpose of this study is to investigate the effect of sulforaphane from macerated broccoli sprouts in humans and to evaluate less invasive methods of assessing potential anti-inflammatory drugs in cystic fibrosis.

Status: Completed

 

NCT01357070  Effect of Broccoli Sprout on Blood Levels of Sulforaphane to Reduce Responsiveness of Immune System.  [P.C. Evans, Imperial College London, United Kingdom]  With particular attention to its role in reducing atherosclerosis, investigators want to test whether the consumption of a brocco-sprout smoothie containing sulforaphane can protect white blood cells from becoming activated in the presence of an experimental stress and how long this protective effect lasts for. To do this, the investigators will be analyzing inflammatory changes in blood samples taken at different times during the study.

Status: Completed

 

NCT01522703  Effects of Whole Sprouts on Upper Airway Allergic Inflammation. [E. Matsui, Johns Hopkins University, Baltimore, MD]  The primary objective of this study is to determine if broccoli sprouts (BS) improves nasal inflammatory, oxidative stress (OS), and symptom responses to nasal mouse allergen challenge (NAC) in mouse-sensitized adults perennial allergic rhinitis. The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 24 mouse-sensitized adults with asthma or perennial rhinitis and who develop rhinitis symptoms with nasal mouse allergen challenge. Twenty-four adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo. At the baseline NAC, FENO, FEV1, nasal epithelial gene expression, urinary OS biomarkers, serum inflammatory and OS biomarkers, basophil activation, and symptoms will be assessed both before and after NAC to establish pre-intervention responses to NAC. Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat NAC that includes measurement of the above outcomes both before and after NAC.

Status: Completed, has Results

 

NCT01625130  Effect of Sulforaphane-rich Broccoli Sprout Homogenate on Ozone Induced Inflammation Through Modulation of NRF2 (BroccOz). [M. Hernandez, University of North Carolina, Chapel Hill, NC] Purpose: To determine if modulation of NRF2 with a Sulforaphane enriched supplement modifies responses to O3. Participants: Recruitment of up to 70 healthy volunteers, ages 18-50, for completion of 36 volunteers. Procedures: This is a randomized, placebo controlled 2×2 crossover study of treatment with an NRF2 modifier versus placebo in healthy volunteers which will examine airway inflammation before and 4 hours after a 2 hour 0.4 ppm O3 exposure. Participants will be randomized to received either the NRF2 modifier, SFN oral supplement (i.e. broccoli sprout shake), or placebo (alfalfa shake) for 3 days followed by a 0.4 ppm O3 exposure for 2 hours. At least 2 weeks later subjects will return for a 2nd supplementation treatment (using the alternative supplement to that provided initially) followed by an ozone exposure identical to the initial one.

Status: Completed

 

NCT01715480  Effect of Broccoli Sprouts Homogenate on SS RBC. [J.-T. A. Chi  & M. J. Telen, Duke University, Durham, NC] The overall purpose of this study is to obtain a better understanding of the biological response of red blood cells to sulforaphane contained in fresh broccoli sprouts that have been put through a blending process. This study will use commercially available fresh broccoli sprouts certified by Brassica Protection Products LLC (BroccoSprouts®). This product can also be purchased at some local grocery stores in the produce section. It is believed that NRF2, a transcription factor encoded by the NFE2L2 gene, plays a role in the regulation of defense against oxidative stress. The detrimental accelerated breakdown of sickle cell disease (SCD) red blood cells (SS RBC) is partially due to reduced anti-oxidative capacity. Previous analysis of SS RBC microRNAs revealed that a reduced level of NRF2, the master regulator of anti-oxidative stress capacity, contributes to reduced resistance to oxidative stress and increased hemolysis; NRF2 also induces fetal hemoglobin (HbF), which is known to prevent SS RBC sickling.

First, erythroid progenitors from normal and SCD subjects will be tested ex-vivo to find out how sulforaphane, a natural NRF2 activator, affects the oxidative stress capacity, HbF expression, and microRNA expression of red cells.

Second, a pilot clinical trial will be conducted to determine the safety and physiological effects of 3 weeks of daily consumption of broccoli sprout homogenate in a cohort of Hb SS/SB0 thalassemia adult SCD patients. During this study, subjects RBCs will be assayed for changes in anti-oxidative stress capacity and microRNA composition in mature SCD red blood cells.

Status: Completed

 

NCT01716858  An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with Schizophrenia. [Chiba University, Japan]  Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as the electrophilic responsive element or antioxidant responsive element. Recently, we reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with schizophrenia.

Status: Completed

 

NCT01726127  Green Vegetables and Women’s Health. [S. A. Tanumihardjo & N. Binkley, University of Wisconsin, Madison, WI]. 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.

Status: Completed

 

NCT01743924  Bioavailability of Chemopreventive and Nutritional Compounds in Broccoli. [M. C. M. Sardiña, Universidad Politécnica de Cartagena, Murcia, Spain] The aim of this study was to determine the absorption of isothiocyanates (ITC) after ingestion of kailan-hybrid broccoli through the analysis of the correspondent urinary biomarkers. Furthermore, the effect of cooking (microwave) on the mentioned metabolic fate of these ITC was studied comparing to the uncooked vegetable.

Status: Completed

 

NCT01845493  Sulforaphane Supplementation in Atopic Asthmatics. [M. L. Hernandez, University of North Carolina, Chapel Hill, NC] The investigators will perform a pilot study of daily treatment with oral sulforaphane (SFN) for 3 days to determine if Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induction is possible with this supplementation regimen in individuals with allergic asthma.

Status: Completed

 

NCT01879878  Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]. [I. Herr, Heidelberg University, Germany] The goal of the POUDER trial is to determine the feasibility of a randomized controlled trial regarding the application of freeze-dried broccoli sprouts rich in sulforaphane and quercetin in patients with advanced pancreatic ductal adenocarcinoma that receive palliative chemotherapy.

Status: Recruiting

 

NCT01927666  The Conversion of ENcapsulated GlucorAphanin, Gut Microbiota Phylogeny and gEnotype Study (ENGAGE). [R. Mithen, Institute of Food Research, Norwich, Norfolk, United Kingdom] The variation in extent of isothiocyanate (ITC) excretion in urine from a capsule delivered dose of glucoraphanin will correlate with differences in (a) the gut microbiota, and (b) the genotype of key polymorphic genes (GSTM1, GSTT1, and other as yet undetermined candidate genes).

Our study is a human dietary intervention in which participants will consume one capsule containing 100mg purified glucoraphanin from broccoli. The levels of glucoraphanin delivered by the capsule are similar to one to two portions of broccoli. As this is purified glucoraphanin there is no myrosinase enzyme present. All conversion of the glucoraphanin, contained within the capsule, to ITC will therefore occur by enzymes found in the gut microbiota.

The ability of the glucoraphanin in the capsule to be metabolised to ITCs by the gut microflora is unknown and will be assessed by measuring ITCs excreted in the urine.

Status: Completed

 

NCT01929564  Broccoli and Vascular Health Study. [R. Mithen, Institute of Food Research, Norwich, Norfolk, United Kingdom].  The participants of this study will be men & women ≥50 years who are deemed to have a 10-30% risk of developing CVD over the next 10 years. Their risk will be calculated using the Joint British Societies 2 (JBS2) guidelines on the prevention of CVD in clinical practise algorithm. This takes into account the participants age, sex, cholesterol values, blood pressure,family history and their ethnicity (SE Asian or not). The participants will be randomly assigned to one of two groups with the aid of a computer program called “minim” which uses their age, sex, BMI and smoking status to determine which broccoli each participant will consume on the intervention.

This is joint project based at two sites, the Institute of Food (IFR) Research in Norwich and the University of Reading(UoR), in Reading. Samples from the participants at both sites will be analysed at IFR, UoR and companies in the United States.

Status: Completed

NCT01948362  Sulforadex in Healthy Volunteers SAD. [J. Täube, Evgen Pharma, London, United Kingdom] To determine the safety and tolerability of single escalating doses of Sulforadex® in healthy male volunteers.

Status: Completed

 

NCT01950143  Effect of Sulforaphane on Prostate CAncer PrEvention. [R. Mithen, Institute of Food Research, Norwich, United Kingdom] The biology of prostate cancer is associated with changes in genes and metabolites within prostate tissue. There is robust evidence to suggest that a diet rich in broccoli can prevent or retard the development of prostate cancer by influencing these changes. This is likely to be due to a natural chemical that is obtained in these vegetables known as sulforaphane.

In this study, we are seeking to provide further evidence that a diet rich in broccoli may prevent prostate cancer from developing, and to understand how this may happen. We propose to undertake a human intervention study to test the hypothesis that a broccoli-rich diet can alter the metabolism and gene expression within prostate tissue of men under active surveillance in a manner that would reduce the probability of the emergence and progression of aggressive cancerous clones. Participants recruited onto this study will be randomly allocated to one of three dietary groups in which they will be required to consume one portion per week of a broccoli soup delivering a different concentration of sulforaphane. This will be part of their normal diet for one year.

Blood, urine and prostate biopsy tissue will be obtained before and after a 12 month intervention period. Prostate biopsies will be obtained either though transperineal template biopsies, a technique accepted as best clinical practice because it provides better sampling of the prostate, or transrectal ultrasound guided biopsy which is currently the standard of care for obtaining biopsies.

Status: Active, Not Recruiting

 

NCT02055716  Sulforadex in Healthy Human Males MAD. [J. Täubel, Evgen Pharma, London, United Kingdom]. To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male volunteers over 7 days with qd or bid dosing.

Status: Completed

 

NCT02291328  Effects of Brassica on Human Gut Lactobacilli. [R.  Mithen, Institute of Food Research, Norwich, Norfolk, United Kingdom] Brassica vegetables are an important part of the investigators normal diet and are associated with a reduced risk of many chronic diseases. The protective effect may be as a result of the hydrolytic products of compounds contained within these vegetables, called glucosinolates. There is evidence that consumption of Brassica vegetables may cause compositional changes to the investigators gut microbiota. The aim of this study is to see whether a diet rich in Brassica alters the human gut microbiota composition, and specifically whether it causes an increase in the number of the beneficial bacteria known as lactobacilli.

Status: Completed

 

NCT02300324  The Bioavailability Of Sulforaphane From Broccoli Soups Study (BOBS). [R. Mithen, Institute of Food Research, Norwich, Norfolk, United Kingdom]   The investigators propose to undertake an intervention study to measure the bioavailability of SF from the soups used in another intervention study called ESCAPE. The investigators would like to investigate the rate and extent to which SF reaches the systemic circulation and is excreted in urine by measuring SF and its metabolites in plasma and urine samples collected from apparently healthy participants after consumption of the three types of broccoli + stilton soups. The three types of soups are standard broccoli + stilton soups and two high-glucoraphanin (SF precursor) broccoli + stilton soups which are able to deliver different levels of SF.

Status: Completed

 

NCT02336087  Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Metastatic Pancreatic Cancer. [V. Chung, City of Hope Medical Center, Duarte, CA] This pilot phase I trial studies the side effects of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, metformin hydrochloride, and a standardized dietary supplement in treating patients with pancreatic cancer that has spread from where it started to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride, used for diabetes, may also help kill cancer cells. Dietary supplements (curcumin, vitamin D, vitamin K2, vitamin K1, B-6, high selenium broccoli sprouts, epigallocatechin gallate, L-carnitine, garlic extract, genistein, zinc amino chelate, mixed toxopherols, ascorbic acid, D-limonene) can block different targets in the cancer cell simultaneously and may slow down cancer growth. Giving gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, and metformin hydrochloride with a dietary supplement may work better in treating patients with metastatic pancreatic cancer.

Status: Recruiting

 

NCT02404428  Utilizing MRI to Study the Effect of Sulforaphane on Prostate Cancer. [R. Mithen, Institute of Food Research, Norwich, Norfolk, United Kingdom]   The investigators propose to undertake a pilot study on a group of men with early prostate cancer on active surveillance to determine whether a diet rich in broccoli will induce changes in tumor size and blood flow measured by conventional Magnetic Resonance Imaging (MRI) techniques. Men with early prostate cancer on active surveillance who have visible cancer lesions on MRI will be recruited onto this double-blinded randomized intervention and they will be asked to eat one portion of broccoli soup per week for 6 months. The investigators will test two varieties of broccoli(standard and ‘Beneforte extra’ broccoli) that are able to deliver two different levels of sulforaphane (SF), an active compound extensively studied for its potential anticancer properties. This study will involve MRI scans, blood and urine collection before and after a 6 month intervention period. This study design will not only allow us to observe diet-induced changes within the prostate but also at the systemic level. In addition, participant’s lifestyle (habitual diet and physical activity) will be assessed by food diaries and exercise questionnaires.

Status: Terminated

 

NCT02614742  SFX01 After Subarachnoid Haemorrhage. [D. Bulters, Evgen Pharma, London, United Kingdom] This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.

Status: Recruiting

 

NCT02618174  Enhanced Broccoli Consumption After a Liking Norm and Vegetable Variety Message: Effects After a 24 Hour Delay. [J. M. Thomas, University of Birmingham, Birmingham, West Midlands, United Kingdom] Encouraging individuals to eat vegetables is difficult. However, recent evidence suggests that using social-based information might help. For instance, it has been shown that if people think that others are eating lots of fruit and vegetables, that they will consume more of these foods to match the ‘norm’. The purpose of this study was to determine whether a liking social norm (information about how much others like vegetables) would be effective at encouraging people to eat more vegetables and to examine whether these effects are sustained beyond initial exposure (i.e. whether the effect of the norm persists on food selection 24 hours alter).

Status: Completed

 

NCT02758990  Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application. [B. Holohan, Verifomics, LLC, Dallas, TX] The purpose of this study is to study interactions between genes, lifestyle environmental factors like foods, nutritional supplements and non-invasive medical devices and health factors that can be measured without specialized medical equipment in order to develop lifestyle recommendations tailored to individual genetics for a host of common chronic health conditions.

Status: Recruiting

 

NCT02821728  Sulphate Accumulation in Prostate. [R. Mithen, Institute of Food Research, Norwich, Norfolk, United Kingdom] This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm.

Status: Active, Not Recruiting

 

NCT02885025  The Effect of Broccoli Sprout Extract on Allergy Rhinitis. [Z. Li and J. S. Yusin, VA Greater Los Angeles Healthcare System, West Los Angeles, CA]  Allergic rhinitis is a common illness suffered among US Veterans. There are medications that help relieve allergy symptoms, including nasal steroid sprays and antihistamines. Some patients have increase symptoms with exposure to their trigger, such as a grasses when combined with pollution due to oxidative stress from pollution. In this study, patients with allergic rhinitis to grass will be given broccoli sprout extract that contains an antioxidant sulforaphane do see if there is beneficial effect in these patients.

Status: Not Yet Recruiting

 

NCT02970682  SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer. [S. Howell, Evgen Pharma, Liverpool, United Kingdom]  This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.

Patients will be enrolled into one of three study arms (SFX-01 in combination with AI, tamoxifen or fulvestrant) based on their current therapy.

Status: Recruiting

 

NCT03013465  Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers. [C. Charron, USDA-ARS, Beltsville Human Nutrition Research Center, Beltsville, MD]  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.

Status: Recruiting

 

NCT03022214  ADAPT: Efficacy of a Dietary Supplement During and After Exercise. [B. De Roos, University of Aberdeen, Aberdeen, Scotland, United Kingdom] Since 1948, health has been defined as “a state of complete physical, mental and social well-being, and not merely the absence of disease and infirmity” . However, a growing school of thought suggests that health represents an ability to be adaptable and flexible in response to daily stressors. It has been proposed that instead, the view of health should be “towards the ability to adapt and self-manage in the face of social, physical and emotional challenges”, which has been termed “resilience”.

The theory of “resilience” relates health to the body’s capacity to manage daily stressors (such as physical activity or oxidative fluctuations) that challenge homeostasis, with the return to homeostasis resulting from several physiological stress responses. Although this is an all-encompassing model, and the effects of pathogens and other stress factors are also relevant, this study will centre on the physiological aspects on this theory, focusing on the disruption through exercise.

Status: Not yet Recruiting