Development of a protective vaccine against Helicobacter pylori

Helicobacter pylori, which colonizes the stomach and causes the most common chronic infection in man, is associated with peptic ulceration, gastric carcinoma and gastric lymphoma. Studies in animals demonstrated that mucosal immunization could induce immune response against H. pylori and prevent H. pylori infection only if powerful mucosal adjuvants such as cholera toxin (CT) or heat-labile toxin of E. coli (LT) were used along with an H. pylori protein antigen. Adjuvants such as CT or LT cannot be used for humans because of their toxicity. Finding non-toxic alternative adjuvants/immunomodulators or immunization strategies that eliminates the use of adjuvants is critical for the development of efficacious human Helicobacter vaccines. We investigated whether several new adjuvants such as Muramyl Tripeptide Phosphatidylethonolamine (MTP-PE), QS21 (a Quil A derivative), Monophosphoryl lipid A (MPL) or heat shock proteins (HSP) of Mycobacterium tuberculosis could be feasible to develop a safe and effective mucosal vaccine against H. pylori using a murine model. C57/BL6 mice were immunized with liposomes incorporating each adjuvant along with urease, a major antigenic protein of H. pylori, to test their mucosal effectiveness. Since DNA vaccination eliminates both the use of adjuvants and antigens we also investigated whether immunization with plasmid DNA encoding urease could induce protective immunity to H. pylori infection in the same murine model. We found that oral vaccination with liposomal MTP-PE (6.7 m g) and urease, (100 m g) induced antigen-specific systemic and mucosal immune response and protected mice against H. pylori challenge when compared to control groups. Parenteral and mucosal immunizations with as little as 20 m g naked or formulated DNA encoding urease induced systemic and mucosal immune response against urease and partially protected mice against H. pylori infection. DNA vaccination provided long-lasting immunity and serum anti-urease IgG antibodies were elevated for up to 12 months. No toxicity was detected after immunizations with either liposomal MTP-PE and urease or plasmid DNA and both were well tolerated. We conclude that immunization liposomes containing MTP-PE and urease is a promising strategy deserving further investigation and may be considered for humans. DNA vaccination could be used to prime immune response prior to oral protein vaccination and may reduce the dose of protein and adjuvant needed to achieve protective immunity. ^

A review of the effects of Transcendental Meditation on cardiovascular disease

Cardiovascular disease (CVD) is the single greatest cause of death in the United States, accounting for nearly 2400 deaths each day. It is estimated that 79.4 million American adults have some form of the disease, and CVD mortality rates are greater than those of cancer, chronic lower respiratory diseases, accidents and diabetes mellitus combined. Psychosocial stress is a nontraditional risk factor for CVD, and can contribute to the clustering of traditional risk factors as well as to vascular manifestations of the disease. The Transcendental Meditation (TM) technique has been researched as a cost effective intervention aimed at decreasing psychosocial stress. This literature review attempts to analyze randomized controlled clinical trials of TM on cardiovascular disease outcomes. Eleven studies met inclusion criteria and are described below, with statistically significant positive outcomes observed in each study. Studies are grouped by primary outcome reported in the categories of cardiovascular function, blood pressure, and exercise tolerance. The TM intervention significantly decreased insulin resistance, heart rate variability, and carotid intima media thickness and improved exercise tolerance compared to control groups. Seven studies also reported significant decreases in blood pressure among hypertensive and normotensive subjects. Five studies focused solely on African American subjects, a population that has disproportionately higher rates of CVD and hypertension, and found significant improvements in CVD outcomes. Further research is recommended to establish the efficacy of TM on CVD outcomes. Future trials should include larger sample populations, wider ethnic distributions of subjects, and longer follow-up to ascertain the impact of this particular stress reduction technique on cardiovascular disease.^

Yoga off the mat: How far and to whom do the benefits extend?

At least 15 million American adults have participated in yoga at least once in their lifetime (Saper, Eisenberg, Davis, Culpepper, & Phillips, 2004). The field of yoga research is relatively new in the United States, and the majority of studies have concentrated on yoga's effect on measures of physiology (cardiovascular disease, diabetes, obesity) or psychological measures of stress and anxiety. This review attempted to identify studies that had been conducted measuring a different set of outcome measures, specifically violence, trauma, eating, and other behavioral disorders. In 9 of 10 studies reviewed, researchers observed statistically significant effects of yoga interventions. Effects were most evident within multifaceted studies that combined intensive yoga practice with group discussion and training. Only one group (Mitchell, Mazzeo, Rausch, & Cooke, 2007) failed to observe any significant differences between yoga practice groups and control groups. Effects were seen in both sexes, although a majority of the studies were aimed specifically at women. All studies were limited by small sample size and lack of follow-up data. Future research should seek to increase sample size, to diversify recruitment to allow for the randomization of treatment and control groups, and to allow for long-term follow-up.^

Secondary data analysis of a pilot study of use of an instructional video for dietary assessment

Introduction. Food frequency questionnaires (FFQ) are used study the association between dietary intake and disease. An instructional video may potentially offer a low cost, practical method of dietary assessment training for participants thereby reducing recall bias in FFQs. There is little evidence in the literature of the effect of using instructional videos on FFQ-based intake. Objective. This analysis compared the reported energy and macronutrient intake of two groups that were randomized either to watch an instructional video before completing an FFQ or to view the same instructional video after completing the same FFQ. Methods. In the parent study, a diverse group of students, faculty and staff from Houston Community College were randomized to two groups, stratified by ethnicity, and completed an FFQ. The "video before" group watched an instructional video about completing the FFQ prior to answering the FFQ. The "video after" group watched the instructional video after completing the FFQ. The two groups were compared on mean daily energy (Kcal/day), fat (g/day), protein (g/day), carbohydrate (g/day) and fiber (g/day) intakes using descriptive statistics and one-way ANOVA. Demographic, height, and weight information was collected. Dietary intakes were adjusted for total energy intake before the comparative analysis. BMI and age were ruled out as potential confounders. Results. There were no significant differences between the two groups in mean daily dietary intakes of energy, total fat, protein, carbohydrates and fiber. However, a pattern of higher energy intake and lower fiber intake was reported in the group that viewed the instructional video before completing the FFQ compared to those who viewed the video after. Discussion. Analysis of the difference between reported intake of energy and macronutrients showed an overall pattern, albeit not statistically significant, of higher intake in the video before versus the video after group. Application of instructional videos for dietary assessment may require further research to address the validity of reported dietary intakes in those who are randomized to watch an instructional video before reporting diet compared to a control groups that does not view a video.^

Pancreatic cancer deaths in Texas veterans

Background/objective. Several studies have found an increased risk of pancreatic cancer in veterans deployed to Vietnam during the Vietnam War. Diabetes, a known risk factor for pancreatic cancer, has been designated as a service-connected illness in deployed Vietnam veterans. The majority of Vietnam veterans, now between the ages of 55 to 65, have not yet reached the ages of pancreatic cancer’s greatest prevalence, ages 65 to 79. This case-control study utilized 1998 electronic Texas death certificate data for white, black and Hispanic men to explore the question of whether military service was a risk factor for deaths due to pancreatic cancer among men who died in 1998.^ Methods. The primary study included men born between 1927 and 1953, and was a matched case-control study with two control groups; 431 pancreatic cancer cases were birth-year and race-matched one case to two non-neoplastic death controls and, for the second control group, were matched 1:1 with 431 accidental death controls. The exposure was military service, recorded as “yes”, “no” or “unknown” on the death certificate. Conditional logistic regression was used for the data analysis. Logistic regression was used in two additional unmatched analyses to examine the same exposure, military service, within different birth cohorts, again using pancreatic cancer cases with non-neoplastic and accidental death controls.^ Results. For pancreatic cancer cases matched to non-neoplastic controls, the association with military service showed an elevated odds ratio (OR) of 1.40 (95% confidence interval [CI] 1.10-1.79); matched to accidental death controls, a similar association with military service was detected [OR=1.40 (95% CI 1.04-1.89)]. The association was not seen in all time periods and was greatest for those within a birth cohort specific for Vietnam Era service. For men born between 1946 and 1950, OR=1.90 (95% CI 1.03-3.50) for comparison with non-neoplastic controls and OR=1.91 (95% CI 0.9995-3.64) for accidental death controls. ^ Conclusion. In Texas, for men aged 44-71, who died in 1998, military service was associated with an approximately 40% increased risk for pancreatic cancer. For men ages 48-52, military service was associated with an approximately 90% increased risk for pancreatic cancer.^

Hypogonadism in male cancer patients: A cross-sectional study

Introduction. Cancer is the second most common cause of death in the USA (2). Studies have shown a coexistence of cancer and hypogonadism (9,31,13). The majority of patients with cancer develop cachexia, which cannot be solely explained by anorexia seen in these patients. Testosterone is a male sex hormone which is known to increase muscle mass and strength, maintain cancellous bone mass, and increase cortical bone mass, in addition to improving libido, sexual desire, and fantasy (14). If a high prevalence of hypogonadism is detected in male cancer patients, and a significant difference exists in testosterone levels in cancer patients with cachexia versus those without cachexia, testosterone may be administered in future randomized trials to help alleviate cachexia. Study group and design The study group consisted of male cancer patients and non-cancer controls aged between 40 and 70 years. The primary study design was cross-sectional with a sample size of 135. The present data analysis is done on a subset convenience sample of 72 patients recruited between November 2006 and January 2010. ^ Methods. Patients aged 40-70 years with or without a diagnosis of cancer were recruited into the study. All patients with a BMI over 35, significant edema, non-melanomatous skin cancer, current alcohol or illicit drug abuse, concomitant usage of medications interfering with gonadal axis, and anabolic agents, patients on tube feeds or parenteral nutrition within 3 months prior to enrollment were excluded from the study. The study was approved by the Institutional Review Board of Baylor College of Medicine and is being conducted at the Michael E. DeBakey Veterans Affairs Medical Center at Houston. My thesis is a pilot data analysis that employs a smaller subset convenience sample of 72 patients determined by using the data available for the 72 patients (of the intended sample of 135 patients) recruited between November 2006 and January 2010. The primary aim of this analysis is to compare the proportion of patients with hypogonadism in the male cancer and non-cancer control groups, and to evaluate if a significant difference exists with respect to testosterone levels in male cancer patients with cachexia versus those without cachexia. The procedures of the study relevant to the current data analysis included blood collection to measure levels of testosterone and measurement of body weight to categorize cancer patients into cancer cachexia and cancer non-cachexia sub-groups. ^ Results. After logarithmic transformation of data of cancer and control groups, the unpaired t test with unequal variances was done. The proportion of patients with hypogonadism in the male cancer and non-cancer control groups was 47.5% and 22.7% with a Pearson chi2 statistic of 1.6036 and a p value of 0.205. Comparing the mean calculated Bioavailable testosterone in male cancer patients and non-cancer controls resulted in a t statistic of 21.83 and a p value less than 0.001. When the cancer group alone was taken, the mean free testosterone, calculated bioavailable testosterone and total testosterone levels in the cancer non-cachexia sub-group were 3.93, 5.09, 103.51 respectively and in the cancer cachexia sub-group were 3.58, 4.17, 84.08 respectively. The unpaired t test with equal variances showed that the two sub-groups had p values of 0.2015, 0.1842, and 0.4894 with respect to calculated bioavailable testosterone, free testosterone, and total testosterone respectively. ^ Conclusions. The small sample size of this exploratory study, resulting in a small power, does not allow us to draw definitive conclusions. For the given sub-sample, the proportion of patients with hypogonadism in the cancer group was not significantly different from that of patients with hypogonadism in the control group. Inferences on prevalence of hypogonadism in male cancer patients could not be made in this paper as the sub-sample is small and therefore not representative of the general population. However, there was a statistically significant difference in calculated Bioavailable testosterone levels in male cancer patients versus non-cancer controls. Analysis of cachectic and non-cachectic patients within the male cancer group showed no significant difference in testosterone levels (total, free, and calculated bioavailable testosterone) between both sub-groups. However, to re-iterate, this study is exploratory and the results may change once the complete dataset is obtained and analyzed. It however serves as a good template to guide further research and analysis.^

Behavioral journalism newsletters to increase employee participation in a free worksite wellness center

Background. Providing an worksite fitness center for employees is an effective setting to increase an adult’s levels of physical activity, demonstrably reducing health care costs and elevating employee productivity. Increasing compliance and adherence among employees to consistently utilize an onsite facility remains a challenge.^ Purpose. To illustrate if two electronic behavioral journalism newsletters can increase employee participation in a free worksite wellness center.^ Design. A randomized control trial was implemented. ^ Setting. A large petroleum-producing corporation located in Houston, Texas Subjects.70 full or part time employees that had checked into visited the wellness center during September, October, and November 2009. ^ Intervention. Two behavioral journalism newsletters were created based on authentic community member role model interviews. Newsletters were distributed to intervention group participants via company email. Intervention and control group participant’s visits to the wellness center were monitored via a key card check in system at the facility for two weeks following the newsletter intervention.^ Analysis. Count variable statistics were used to identify rate differences between the intervention and control group wellness center visits. A binomial test for equality of proportions was used to identify differences between participants that had at least one visit to the wellness center compared with those with none.^ Results. Both intervention and control groups had a baseline of zero wellness center visits. The control group had a mean visit rate 0.441 and the intervention group had 0.857. A 0.416, almost one half more visits were found among the intervention group.^ Conclusion. This study indicates that behavioral journalism newsletters featuring a role model from within the worksite population can be a cost effective communication method to improve participation in an onsite wellness center. ^

An interactive intervention to impact adherence to antiretroviral treatment among treatment-naive HIV-infected adults in Thailand: A pilot randomized controlled study

Background. Consistent adherence to antiretroviral treatment is necessary for a treatment success. Improving and maintaining adherence rate >95% are challenging for health care professionals. This pilot randomized controlled study aimed to evaluate the impact of the interactive intervention on adherence to GPO-VIR, to describe the feasibility of the interactive intervention in Thailand, and to illustrate the adherence self-efficacy concept among HIV treatment-naïve patients in Thailand who were starting antiretroviral treatment. ^ Methods. The study took place at three HIV clinics located in Phayao, Thailand. Twenty-three patients were randomly assigned into the experimental (n=11) and the control groups (n=12). Each participant in the experimental group and a significant person to the patient received 5 educational sessions with a nurse at the clinics and at their homes. They also received 3 follow-up evaluations during the 6-month period of the study. The participants in the control group received the standard of care provided by HIV clinical personnel plus three follow-up evaluations at the clinic. ^ Results. Seventeen patients (7 in the experimental and 10 in the control group) completed the study. The 4-day recall on the Thai ACTG Adherence Scale demonstrated adherence rate >95% for most participants from both groups. After the first measurement, no experimental group patients reporting missing ART, while one control group participant continuously skipped ART. Participants from both groups had significantly increased CD4 cell counts after the study (F(1, 15) = 29.30, p = .000), but no differences were found between two groups (F(1, 15) = .001, p = .98). Examination of the intervention showed limitations and possibilities to implement it in Thailand. Qualitative data demonstrated self-efficacy expectations, resignation and acceptance as related concepts to improve adherence outcomes. ^ Conclusions. This interactive intervention, after appropriate modifications, is feasible to apply for Thai HIV-treatment naïve patients. Because of limitations the study could not demonstrate whether the interactive intervention improved adherence to ART among HIV-treatment naïve in Thailand. A longitudinal study in a larger sample would be required to test the impact of the intervention. ^ Keyword: antiretroviral treatment, adherence, treatment-naïve, Thailand, randomized controlled study ^

Multivariate methods for correlated effects sizes

Current statistical methods for estimation of parametric effect sizes from a series of experiments are generally restricted to univariate comparisons of standardized mean differences between two treatments. Multivariate methods are presented for the case in which effect size is a vector of standardized multivariate mean differences and the number of treatment groups is two or more. The proposed methods employ a vector of independent sample means for each response variable that leads to a covariance structure which depends only on correlations among the $p$ responses on each subject. Using weighted least squares theory and the assumption that the observations are from normally distributed populations, multivariate hypotheses analogous to common hypotheses used for testing effect sizes were formulated and tested for treatment effects which are correlated through a common control group, through multiple response variables observed on each subject, or both conditions.^ The asymptotic multivariate distribution for correlated effect sizes is obtained by extending univariate methods for estimating effect sizes which are correlated through common control groups. The joint distribution of vectors of effect sizes (from $p$ responses on each subject) from one treatment and one control group and from several treatment groups sharing a common control group are derived. Methods are given for estimation of linear combinations of effect sizes when certain homogeneity conditions are met, and for estimation of vectors of effect sizes and confidence intervals from $p$ responses on each subject. Computational illustrations are provided using data from studies of effects of electric field exposure on small laboratory animals. ^

AMERICAN TRYPANOSOMIASIS (CHAGAS') DISEASE - A STUDY OF FETO-MATERNAL MORBIDITY AND MORTALITY

The possibility of a relationship between American Trypanosomiasis (Chagas') disease and pregnancy outcome was analyzed measuring feto-maternal morbidity and mortality in a sample of 604 pregnant women and their offspring seen at the Hospital Universitario de Maternidad y Neonatologia in Cordoba, Argentina during 1979.^ A cross-sectional, "case-comparison" investigation was employed to determine the degree of risk between having a reactive chagasic serologic test and a negative pregnancy outcome as determined by abortion, stillbirth, and infant death prior to one week of age. Patients were selected using a dichotomous, 0-1 scale with either the presence or the absence of a reactive Machado-Guerreiro complement fixation serologic blood test result.^ The data obtained were analyzed using appropriate statistical techniques for measuring the comparisons between the case and control groups under various demographic and socioeconomic variables such as, age, marital status, educational attainment, and residence. Similarly, additional biological variables of birth order, maternal and fetal complications, and prematurity were examined.^ From the analysis of the data obtained in this investigation, no definite conclusions can be reached regarding the risk of having an unsuccessful pregnancy outcome in the presence of a reactive serologic finding because the study design was a cross-sectional one and the number of events were too few for an adequate analysis. Notwithstanding these limitations, the results obtained, after statistical adjustments were employed, demonstrated that women with a reactive test result were older, were of a higher parity, and were less educated. Marital status and residence were not significant variables. The risk of pregnancy wastage, however, was almost twice as frequent in the reactive group as in the non-reactive group of women. Statistically significant differences in maternal morbidity involved two complications, polyhydramnios and varicosities of the lower extremities and vulva; while in the newborn, infection was higher in infants whose mothers exhibited a reactive serologic test result.^ In summary, what this research study has shown is the need for engaging in a larger, longitudinal study for an in-depth exploration of feto-maternal morbidity and mortality--an investigation that would corraborate or refute the findings of this study.^

Improving adherence in African American women with uncontrolled primary hypertension

Background and Objectives: African American (AA) women are disproportionately affected with hypertension (HTN). The aim of this randomized controlled trial was to evaluate the effectiveness of a 6-week culturally-tailored educational intervention for AA women with primary HTN who lived in rural Northeast Texas. ^ Methods: Sixty AA women, 29 to 86 years (M 57.98 ±12.37) with primary HTN were recruited from four rural locations and randomized to intervention (n =30) and wait-list control groups ( n =30) to determine the effectiveness of the intervention on knowledge, attitudes, beliefs, social support, adherence to a hypertension regimen, and blood pressure (BP) control. Survey and BP measurements were collected at baseline, 3 weeks, 6 weeks (post intervention) and 6 months post intervention. Culturally-tailored educational classes were provided for 90 minutes once a week for 6 weeks in two local churches and a community center. The wait-list control group received usual care and were offered education at the conclusion of the data collection six months post-intervention. Linear mixed models were used to test for differences between the groups. ^ Results: A significant overall main effect (Time) was found for systolic blood pressure, F(3, 174) =11.104, p=.000, and diastolic blood pressure. F(3, 174) =4.781, p=.003 for both groups. Age was a significant covariate for diastolic blood pressure. F(1, 56) =6.798 p=.012. Participants 57 years or older (n=30) had lower diastolic BPS than participants younger than 57 (n=30). No significant differences were found between groups on knowledge, adherence, or attitudes. Participants with lower incomes had significantly less knowledge about HBP Prevention (r=.036, p=.006). ^ Conclusion: AA women who participated in a 6 week intervention program demonstrated a significant decrease in BP over a 6 month period regardless of whether they were in the intervention or control group. These rural AA women had a relatively good knowledge of HTN and reported an average level of compliance, compared to other populations. Satisfaction with the program was high and there was no attrition, suggesting that AA women will participate in research studies that are culturally tailored to them, held in familiar community locations, and conducted by a trusted person with whom they can identify. Future studies using a different program with larger sample sizes are warranted to try to decrease the high level of HTN-related complications in AA women. ^

Does prior receipt of a rifamycin antibiotic increase the risk of acquiring an infection due to a rifamycin-resistant strain of Clostridium difficile?

Objectives. To examine the association between prior rifamycin exposure and later development of C. difficile infection (CDI) caused by a rifamycin-resistant strain of C. difficile , and to compare patient characteristics between rifamycin-resistant strains of C. difficile infection and rifamycin-susceptible strains of C. difficile infection. ^ Methods. A case-control study was performed in a large university-affiliated hospital in Houston, Texas. Study subjects were patients with C. difficile infection acquired at the hospital with culture-positive isolates of C. difficile with which in vitro rifaximin and rifampin susceptibility has been tested. Prior use of rifamycin, demographic and clinical characteristics was compared between case and control groups using univariate statistics. ^ Results. A total of 49 C. difficile strains met the study inclusion criteria for rifamycin-resistant case isolates, and a total of 98 rifamycin-susceptible C. difficile strains were matched to case isolates. Of 49 case isolates, 12 (4%) were resistant to rifampin alone, 12 (4%) were resistant to rifaximin alone, and 25 (9%) were resistant to both rifampin and rifaximin. There was no significant association between prior rifamycin use and rifamycin-resistant CDI. Cases and controls did not differ according to demographic characteristics, length of hospital stay, known risk factors of CDI, type of CDI-onset, and pre-infection medical co-morbidities. Our results on 37 rifaximin-resistant isolates (MIC ≥32 &mgr;g/ml) showed more than half of isolates had a rifaximin MIC ≥256 &mgr;g/ml, and out of these isolates, 19 isolates had MICs ≥1024 &mgr;g/ml. ^ Conclusions. Using a large series of rifamycin-non-susceptible isolates, no patient characteristics were independently associated with rifamycin-resistant CDI. This data suggests that factors beyond previous use of rifamycin antibiotics are primary risk factors for rifamycin-resistant C. difficile. ^

Is obesity a possible risk factor for Clostridium difficile infection

Aims: Obesity is a state of chronic inflammation characterized by depressed Th2 immune response. Animal studies have shown decreased IgA levels in obese rats and Leptin an adipose cell origin cytokine have been shown to enhance the activity of Clostridium difficile Toxin A. Hence we hypothesized that obesity is a risk factor for C. difficile infection (CDI) ^ Methods: 33 cases of CDI and 131 controls matched by age and HORNS index were identified from an IRB approved observational study at St. Luke's Episcopal Hospital in Houston. Variables like age, gender, height, weight, chronic antibiotic use, proton pump inhibitor use, diabetes mellitus, myocardial infarction, inflammatory bowel disease, diverticulitis, transfer from nursing home, hospital or home, nasogastric tube use and use of hemodialysis were provided in the dataset. Height and weight of the patient were used to calculate the BMI, based on which the study subjects were classified as obese and non-obese. Using STATA these variables were analyzed using test, chi square test followed by conditional logistic regression. ^ Results: On univariate analysis and conditional logistic regression, no significant increase in risk was associated with obesity (OR: 1.24; 95% CI: 0.46 - 3.36; p = 0.67) or BMI (OR: 0.98; CI: 0.92 - 1.04; p = 0.92). Hence, we cannot reject our hypothesis and conclude that "obesity is a risk factor associated with higher incidence of CDI in hospitalized patients. On univariate analysis using hemodialysis, nursing home transfer, home transfer, PPI and chronic antibiotics were found to be significantly different (p<0.05) in the cases and controls. On conditional logistic regression home (OR: 3.4; 95% CI: 1.15 - 9.61) and hemodialysis (OR: 4.1; 95% CI: 1.14 - 15.57) were found to be significantly different (p<0.05) between the case and control groups. ^ Conclusion: Our results show that obesity is not a significant risk factor for CDI. Our sample size was small and hence this may need conformation with a larger study. Patients transferred from home to the hospital and patients on hemodialysis had significantly higher incidence of CDI.^

The effects of omega -3 fatty acid -enriched fish on C -reactive protein levels in postmenopausal women

Coronary heart disease (CHD) is the leading cause of death in women and rates markedly increase among women after 65 years of age. C-reactive protein (CRP) is a new clinical indicator of atherosclerotic-related inflammation with a direct pathogenic role. Studies show lifestyle factors can modulate CRP. Omega-3 fatty acids have anti-inflammatory properties and studies suggest that eating fish high in omega-3 fatty acids may lower CHD risk in women. This study sought to assess the possible role of omega-3 fatty acids in the reduction of CHD-related inflammation by investigating the effect of fish consumption on CRP levels. Methods. Twenty-four healthy postmenopausal women were randomly assigned to a fish group (usual diet plus two servings per week of enriched fish) or control group (usual diet with no fatty fish) for eight weeks. Omega-3 fatty acid-enriched fish developed by the West Virginia University Aquaculture Division was used. Serum CRP, serum interleukin-6 (IL-6), and the fatty acid content of red blood cells (RBC) were measured before and after the study. Women also completed food records. RESULTS: Baseline levels of CRP were low (85% of the fish group had normal levels) and few changes in CRP risk category were observed. Mean IL-6 levels were reduced by 27% and 35% in the fish and control groups, respectively (p for between-group difference = 0.60). Changes in RBC fatty acid composition were not statistically significant. Compared to control women, women in the fish group had greater reductions in mean triglycerides (p = 0.08), total cholesterol (P = 0.04), and LDL cholesterol levels (p = 0.06). Baseline dietary intake of total and monounsaturated fatty acids tended to be positively associated with baseline CRP, while vitamin E intake was inversely related. Saturated fat intake tended to have a positive association with IL-6. Conclusions. Findings regarding the effect of two servings of fish on CRP and IL-6 levels are inconclusive due to low baseline levels of CRP and IL-6. However, results indicate two servings of fatty fish have favorable effects on blood lipids. The relationship of dietary components with CRP and IL-6 is complex and further research is needed to determine the varying roles of diet on the inflammatory process. ^