The effect of a fermented soy beverage among patients with localized prostate cancer prior to radical prostatectomy.

BACKGROUND: Fermented soy products have shown to possess inhibitory effects on prostate cancer (PCa). We evaluated the effect of a fermented soy beverage (Q-Can®), containing medium-chain triglycerides, ketones and soy isoflavones, among men with localized PCa prior to radical prostatectomy. METHODS: We conducted a placebo-controlled, double-blind randomized trial of Q-Can®. Stratified randomization (Cancer of the Prostate Risk Assessment (CAPRA) score at diagnosis) was used to assign patients to receive Q-Can® or placebo for 2-5 weeks before RP. Primary endpoint was change in serum PSA from baseline to end-of-study. We assessed changes in other clinical and pathologic endpoints. The primary ITT analysis compared PSA at end-of-study between randomization arms using repeated measures linear mixed model incorporating baseline CAPRA risk strata. RESULTS: We randomized 19 patients, 16 were eligible for analysis of the primary outcome. Mean age at enrollment was 61, 9(56.2%) were classified as low and intermediate risk, and 7(43.8%) high CAPRA risk. Among patients who received Q-Can®, mean PSA at baseline and end-of-study was 8.98(standard deviation, SD 4.07) and 8.02ng/mL(SD 3.99) compared with 8.66(SD 2.71) to 9.53ng/mL(SD 3.03), respectively, (Difference baseline - end-of-study, p = 0.36). There were no significant differences in Gleason score, clinical stage, surgical margin status, or CAPRA score between treatment arms (p > 0.05), and no significant differences between treatment arms in end-of-study or change in lipids, testosterone and FACT-P scores (p > 0.05). CONCLUSIONS: Short exposure to Q-Can® among patients with localized PCa was not associated with changes in PSA levels, PCa characteristics including grade and stage or serum testosterone. Due to early termination from inability to recruit, study power, was not achieved.

Fermented Soy Drink (Q-CAN® PLUS) Induces Apoptosis and Reduces Viability of Cancer Cells.

This study tested the ability of a fermented soy product to induce tumor cell toxicity and to assess if this was due to fermentation of soy, and to the genistein content. Four cancer cell lines were cultured without additive, with fermented soy (Q-CAN® PLUS), nonfermented soy, or genistein, and cell viability was examined at 24 h, 48 h, and 72 h. The sensitivity of the cell lines to apoptosis by Q-CAN PLUS was tested with the Annexin V assay. All cell lines demonstrated a dose and time response reduction in tumor cell viability with exposure to Q-CAN PLUS (IC50 at 24 h 3.8 mg/mL to 9 mg/mL). Unfermented soy did not show reduction in viability of any cell line within the same concentration range. The IC50 of genistein for each of the cell lines was significantly greater than for Q-CAN PLUS. All four tumor cell lines demonstrated apoptosis in response to Q-CAN PLUS. Q-CAN PLUS reduces viability and increases apoptosis of cancer cells in a concentration- and fermentation-dependent manner. Taking into consideration the IC50 of genistein and the concentration of genistein in Q-CAN PLUS, the genistein content of Q-CAN PLUS is not responsible for the majority reduction in tumor cell viability. This suggests that fermentation of soy results in the production of metabolites that reduce cancer cell viability and induce cellular apoptosis, and play a major role in addition to any effects produced by their genistein content.

The fermented soy beverage Q-CAN® plus induces beneficial changes in the oral and intestinal microbiome.

BACKGROUND: Soy products are associated with many beneficial health consequences, but their effects on the human intestinal microbiome are poorly characterized. OBJECTIVES: To identify the changes in the oral and fecal microbiome in lean and obese participants due to consumption of Q-CAN®, and to assess the expected consequences of these changes based on the published literature. METHODS: Prospective study of lean (10) and obese (9) participants consuming Q-CAN® twice daily for 4 weeks with 8 weeks follow-up. Microbial DNA was extracted from saliva and stool samples, amplified against the V4 region of the 16S ribosomal RNA gene and data analyzed using QIIME 1.9.1 bioinformatics. Four hundred forty-four samples were collected in total, 424 of which were productive and yielded good quality data. RESULTS: STOOL. In the lean population Bifidobacteria and Blautia show a significant increase while taking Q-CAN®, and there was a trend for this in the obese population. ORAL. There were relatively fewer major changes in the oral microbiome with an increase in the family Veillonellaceae in the lean population while on Q-CAN®. CONCLUSION: Q-CAN® consumption induced a number of significant changes in the fecal and oral microbiome. Most notably an increase in the stool microbiome of Bifidobacteria and Blautia, both of which are associated with positive health benefits, and in the saliva an increase in Veillonellaceae. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov on January 14th 2016. ClinicalTrials.gov Identifier: NCT02656056.

Fermented Soy Beverage Q-CAN Plus Consumption Improves Serum Cholesterol and Cytokines.

Soy-based beverages are well recognized for their rich nutritional contents and positive health benefits. However, there is little information regarding the composition of various commercially available soy-based beverages and uncertainty among patients regarding the utility of fermented soy products. Current study evaluates the health benefits of QCAN® Plus-an easily available fermented soy drink. This study was performed in lean (n = 10) and obese (n = 10) subjects. The subjects were observed during pre-soy (weeks -2, -1, and 0), on-soy (weeks 1, 2, 3, and 4), and post-soy (weeks 6, 8, 10, and 12) periods. The serum samples during these visits were subjected to lipid profile analysis and multiplex assay for cytokines. The results revealed that total cholesterol and low-density lipoprotein (LDL) cholesterol levels were significantly reduced in both lean and obese individuals during on-soy (P ≤ .05). Furthermore, cytokines such as platelet-derived growth factor (PDGF) AA and AB/BB were significantly lowered on-soy compared with pre-soy (P ≤ .05) in lean subjects and PDGF AA, IL-1RA, and GMCSF were significantly reduced on-soy (P ≤ .05) in obese subjects. In addition, a qualitative and quantitative analysis of the Q-CAN Plus by a third-party laboratory confirmed its chemical and microbial safety. Our preliminary study on Q-CAN Plus ensures its safety for consumption and highlights its hypolipidemic and suppressive effect on certain cytokines. These observations and relevant studies in future might guide clinicians in future to consider Q-CAN Plus as a therapeutic nutritional supplement.

Refusal of Vitamin K by Parents of Newborns: A Qualitative Study.

OBJECTIVE: Despite American Academy of Pediatrics recommendations, some parents refuse intramuscular (IM) vitamin K as prophylaxis against vitamin K deficiency bleeding for their newborns. The purpose of our study was to describe attitudes and perceptions of parents who choose to defer IM vitamin K for their newborns. METHODS: Using qualitative methodology, we conducted in-depth semi-structured interviews with parents of newborns in 3 hospitals in Connecticut and California. We used the grounded theory approach and the constant comparative method until saturation was reached. RESULTS: Nineteen participants (17 mothers and 2 fathers) of 17 newborns were interviewed; 14 newborns did not receive IM vitamin K due to refusal by the parents, and for 3 newborns IM vitamin K administration was delayed due to initial hesitation by the parents. Four major themes emerged: 1) risk-to-benefit ratio, where parents refused IM vitamin K due to a perceived risk to their newborn from preservatives, for example; 2) "natural" approaches, which led to seeking oral vitamin K or increasing the mother's own prenatal dietary vitamin K intake; 3) placement of trust and mistrust, which involved mistrust of the medical and pharmaceutical community with overlapping concerns about vaccines and trust of self, like-minded allopathic and non-allopathic health care providers, the social circle, the internet, and social media; and 4) informed by experiences, reflecting hospital experiences with prior pregnancies and communication with health care providers. CONCLUSIONS: Parents' perception of risk, preference for alternative options, trust, and communication with health care providers were pivotal factors when making decisions about IM vitamin K.

A leukocyte activation test identifies food items which induce release of DNA by innate immune peripheral blood leucocytes.

BACKGROUND: Leukocyte activation (LA) testing identifies food items that induce a patient specific cellular response in the immune system, and has recently been shown in a randomized double blinded prospective study to reduce symptoms in patients with irritable bowel syndrome (IBS). We hypothesized that test reactivity to particular food items, and the systemic immune response initiated by these food items, is due to the release of cellular DNA from blood immune cells. METHODS: We tested this by quantifying total DNA concentration in the cellular supernatant of immune cells exposed to positive and negative foods from 20 healthy volunteers. To establish if the DNA release by positive samples is a specific phenomenon, we quantified myeloperoxidase (MPO) in cellular supernatants. We further assessed if a particular immune cell population (neutrophils, eosinophils, and basophils) was activated by the positive food items by flow cytometry analysis. To identify the signaling pathways that are required for DNA release we tested if specific inhibitors of key signaling pathways could block DNA release. RESULTS: Foods with a positive LA test result gave a higher supernatant DNA content when compared to foods with a negative result. This was specific as MPO levels were not increased by foods with a positive LA test. Protein kinase C (PKC) inhibitors resulted in inhibition of positive food stimulated DNA release. Positive foods resulted in CD63 levels greater than negative foods in eosinophils in 76.5% of tests. CONCLUSION: LA test identifies food items that result in release of DNA and activation of peripheral blood innate immune cells in a PKC dependent manner, suggesting that this LA test identifies food items that result in release of inflammatory markers and activation of innate immune cells. This may be the basis for the improvement in symptoms in IBS patients who followed an LA test guided diet.

Efficacy of individualised diets in patients with irritable bowel syndrome: a randomised controlled trial.

BACKGROUND: Patients with irritable bowel syndrome (IBS) are often placed on diets guided by food intolerance assays, although these have not been validated. We assessed the effects of individualised diets in patients with IBS guided by a leucocyte activation test. METHODS: This is a parallel-group, double-blind, randomised controlled trial of 58 adults with IBS seen at an academic health centre in Northeast USA. Peripheral venous blood was analysed using a leucocyte activation test; individual foods were reported to produce positive or negative results. Participants were randomised to a 4-week diet with either individualised guidance to eliminate foods with positive assay results and allow foods with negative assay results (intervention), or with individualised guidance, matched in rigour and complexity, to eliminate foods with negative assay results and allow foods with positive assay results (comparison). The primary outcome was between-group differences in the IBS Global Improvement Scale (GIS). Secondary outcomes included reductions in IBS Symptom Severity Scale (SSS) scores and increases in IBS Adequate Relief (AR) and Quality of Life (QOL) scores. An aptamer-based proteomic analysis was conducted in strong responders. RESULTS: The intervention group had significantly greater increases in mean GIS score after 4 weeks (0.86 vs comparison; 95% CI 0.05 to 1.67; p=0.04) and 8 weeks (1.22 vs comparison; 95% CI 0.22 to 2.22; p=0.02). The intervention group also had significantly greater reductions in mean SSS score at 4 weeks (-61.78 vs comparison; 95% CI -4.43 to -119.14; p=0.04) and 8 weeks (-66.42 vs comparison; 95% CI -5.75 to -127.09; p=0.03). There were no significant differences between intervention and comparison groups in mean AR or QOL scores. A reduction in neutrophil elastase concentration was associated with reduced symptoms. CONCLUSIONS: Elimination diets guided by leucocyte activation tests reduced symptoms. These findings could lead to insights into the pathophysiology of IBS. TRIAL REGISTRATION NUMBER: NCT02186743.

Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study.

OBJECTIVE: To assess the feasibility of a mindfulness-based stress reduction (MBSR) program for adolescents with widespread chronic pain and other functional somatic symptoms and to make preliminary assessments of its clinical utility. STUDY DESIGN: Three cohorts of subjects completed an 8-week MBSR program. Child- and parent-completed measures were collected at baseline and 8 and 12 weeks later. Measures included the Functional Disability Inventory (FDI), the Fibromyalgia/Symptom Impact Questionnaire-Revised (FIQR/SIQR), the Pediatric Quality of Life Inventory, the Multidimensional Anxiety Scale (MASC2), and the Perceived Stress Scale. Subjects and parents were interviewed following the program to assess feasibility. RESULTS: Fifteen of 18 subjects (83%) completed the 8-week program. No adverse events occurred. Compared with baseline scores, significant changes were found in mean scores on the FDI (33% improvement, P = .026), FIQR/SIQR (26% improvement, P = .03), and MASC2 (child: 12% improvement, P = .02; parent report: 17% improvement, P = .03) at 8 weeks. MASC2 scores (child and parent) and Perceived Stress Scale scores were significantly improved at 12 weeks. More time spent doing home practice was associated with better outcomes in the FDI and FIQR/SIQR (44% and 26% improvement, respectively). Qualitative interviews indicated that subjects and parents reported social support as a benefit of the MBSR class, as well as a positive impact of MBSR on activities of daily living, and on pain and anxiety. CONCLUSIONS: MBSR is a feasible and acceptable intervention in adolescents with functional somatic syndromes and has preliminary evidence for improving functional disability, symptom impact, and anxiety, with consistency between parent and child measures. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02190474.

Massage Therapy and Quality of Life in Osteoarthritis of the Knee: A Qualitative Study.

Objective: We hypothesized that participants receiving Swedish massage would experience benefits such as stress reduction and enhanced quality of life, in addition to the osteoarthritis-specific effects assessed in a randomized controlled clinical trial. Design: Qualitative methods were used to explore a deeper contextual understanding of participants' experiences with massage and osteoarthritis, in addition to the quantitative data collected from primary and secondary outcome measures of the dose-finding study. Setting: Two community hospitals affiliated with academic health centers in Connecticut and New Jersey. Subjects: Eighteen adults who previously participated in a dose-finding clinical trial of massage therapy for osteoarthritis of the knee. Methods: Face-to-face and telephone interviews using a standardized interview guide. Triangulation of qualitative and quantitative data allowed for a more thorough understanding of the effects of massage therapy. Results: Three salient themes emerged from our analysis. Participants discussed 1) relaxation effects, 2) improved quality of life associated with receiving massage therapy, and 3) the accessibility of massage therapy in treating osteoarthritis. Conclusions: Participant responses noted empowerment with an improved ability to perform activities of daily living after experiencing massage therapy. The majority of statements were consistent with their quantitative changes on standard osteoarthritis measures. Future research in pain conditions should include health-related quality of life assessments as well as outcomes related to perceived well-being, along with greater exploration of the concept of salutogenic side effects of an intervention in the context of complementary and integrative therapies.

Proximity to natural gas wells and reported health status: results of a household survey in Washington County, Pennsylvania.

BACKGROUND: Little is known about the environmental and public health impact of unconventional natural gas extraction activities, including hydraulic fracturing, that occur near residential areas. OBJECTIVES: Our aim was to assess the relationship between household proximity to natural gas wells and reported health symptoms. METHODS: We conducted a hypothesis-generating health symptom survey of 492 persons in 180 randomly selected households with ground-fed wells in an area of active natural gas drilling. Gas well proximity for each household was compared with the prevalence and frequency of reported dermal, respiratory, gastrointestinal, cardiovascular, and neurological symptoms. RESULTS: The number of reported health symptoms per person was higher among residents living < 1 km (mean ± SD, 3.27 ± 3.72) compared with > 2 km from the nearest gas well (mean ± SD, 1.60 ± 2.14; p = 0.0002). In a model that adjusted for age, sex, household education, smoking, awareness of environmental risk, work type, and animals in house, reported skin conditions were more common in households < 1 km compared with > 2 km from the nearest gas well (odds ratio = 4.1; 95% CI: 1.4, 12.3; p = 0.01). Upper respiratory symptoms were also more frequently reported in persons living in households < 1 km from gas wells (39%) compared with households 1-2 km or > 2 km from the nearest well (31 and 18%, respectively) (p = 0.004). No equivalent correlation was found between well proximity and other reported groups of respiratory, neurological, cardiovascular, or gastrointestinal conditions. CONCLUSION: Although these results should be viewed as hypothesis generating, and the population studied was limited to households with a ground-fed water supply, proximity of natural gas wells may be associated with the prevalence of health symptoms including dermal and respiratory conditions in residents living near natural gas extraction activities. Further study of these associations, including the role of specific air and water exposures, is warranted.

Experiences of patients identifying with chronic Lyme disease in the healthcare system: a qualitative study.

BACKGROUND: Chronic Lyme disease is a term that describes a constellation of persistent symptoms in patients with or without evidence of previous Borrelia burgdorferi infection. Patients labeled as having chronic Lyme disease have a substantial clinical burden. Little is known about chronic Lyme disease patient experiences in the healthcare system and their relationships with healthcare providers. The purpose of this study was to gather insights about the experiences of patients who carry a diagnosis of chronic Lyme disease in the United States healthcare system. METHODS: Qualitative, phenomenological study in 12 adult participants who identified themselves as having chronic Lyme disease. Semi-structured face-to-face in-depth interviews were conducted, 60-90 minutes in length, focusing on perceptions of disease burden and of their healthcare providers, using the dimensions of the Health Belief Model. Transcribed interviews were analyzed for emergent topics and themes in the categories of beliefs/understanding, personal history/narrative, consequences/limitations, management, and influences on care. RESULTS: Enrollment continued until theoretical saturation was obtained. Four major themes emerged from participants' descriptions of their experiences and perceptions: 1) changes in health status and the social impact of chronic Lyme disease, 2) doubts about recovery and the future, 3) contrasting doctor-patient relationships, 4) and the use of unconventional therapies to treat chronic Lyme disease. CONCLUSIONS: Participants reported a significant decline in health status associated with chronic Lyme disease and were often unsatisfied with care in conventional settings. Negative experiences were associated with reports of dismissive, patronizing, and condescending attitudes. Positive experiences were associated with providers who were reported to be attentive, optimistic, and supportive. Consultations with CAM practitioners and use of CAM therapies were common. Actively engaged and sympathetic clinical encounters may foster greater satisfaction in healthcare settings.

Young women's experiences living with polycystic ovary syndrome.

OBJECTIVE: To explore the psychosocial effects of living with polycystic ovary syndrome (PCOS) through the experiences of young women diagnosed with this endocrine disorder. DESIGN: A qualitative, phenomenological methodology was used. Data were obtained through personal, semistructured interviews. SETTING: College campuses in New England. PARTICIPANTS: A purposive sample of 12 young women with PCOS age 18 to 23 years. RESULTS: The following themes emerged from analysis of participants' responses: concerns for older self, feeling physically inferior, coping with symptoms, patient-provider relationship, seeking useable information and support, and coming to terms with a chronic condition. CONCLUSIONS: Participants in this study faced numerous physical, social, and emotional challenges on a daily basis. As these young women gathered information relevant to their needs, sought and received social support, and maintained their daily routines to improve their health and appearance, they came to terms with this chronic condition. Based on participants' relayed experiences, it became evident that a need exists for health care practitioners to include psychosocial support in a comprehensive holistic plan for the treatment of PCOS in adolescents and young women in their early twenties.