Background

Bioimpedance analysis (BIA) has been reported as helpful in identifying hypervolemia. Observation data showed that hypervolemic maintenance hemodialysis (MHD) patients identified using BIA methods have higher mortality risk. However, it is not known if BIA-guided fluid management can improve MHD patients’ survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management compared with standard care.

Methods

This is a multicenter, prospective, randomized, controlled trial. More than 1300 participants from 16 clinical sites will be included in the study. The enrolment period will last 6 months, and minimum length of follow-up will be 36 months. MHD patients aged between 18 years and 80 years who have been on MHD for at least 3 months and meet eligibility criteria will be invited to participate in the study. Participants will be randomized to BIA arm or control arm in a 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D GmbH) will be used for BIA measurement at baseline for both arms of the study. In the BIA arm, additional BCM measurements will be performed every 2 months. The primary intent-to-treat analysis will compare outcomes for a composite endpoint of death, acute myocardial infarction, stroke or incident peripheral arterial occlusive disease between groups. Secondary endpoints will include left ventricular wall thickness, blood pressure, medications, and incidence and length of hospitalization.

Discussions

Previous results regarding the benefit of strict fluid control are conflicting due to small sample sizes and unstable dry weight estimating methods. To our knowledge this is the first large-scale, multicentre, prospective, randomized controlled trial to assess whether BIS-guided volume management improves outcomes of MHD patients. The endpoints of the BOCOMO study are of utmost importance to health care providers. In order to obtain that aim, the study was designed with very careful important considerations related to the endpoints, sample size, inclusion criteria, exclusion criteria and so on. For example, annual mortality of Beijing MHD patients was around 10%. To reach statistical significance, the sample size will be very large. By using composite endpoint, the sample size becomes reasonable and feasible. Limiting inclusion to patients with urine volume less than 800 ml/day the day before dialysis session will limit confounding due to residual renal function effects on the measured parameters. Patients who had received BIS measurement within 3 months prior to enrolment are excluded as data from such measurements might lead to protocol violation. Although not all patients enrolled will be incident patients, we will record the vintage of dialysis in the multivariable analysis.

Trial registration

Current Controlled Trials NCT01509937

The balance of putative pro- and anti-inflammatory lipoxygenase (LOX)-derived S-hydroxyeicosatetraenoic acids (S-HETEs) in colon mucosa is a potential target for modulating colon cancer risk and progression. The biological effects of S-HETEs and R-HETEs (produced by distinct pathways) may differ, but levels of these compounds in colon are unknown. The objective of this study was to develop chiral methods to characterize HETE enantiomers in colonic mucosa and evaluate the effects of fish oil on HETE formation. C57BL/6 mice (COX-1 null, COX-2 null, wild-type) were fed a diet supplemented with either olive oil or menhaden oil for 11 weeks, and R/S-HETEs in colonic mucosa were quantified by chiral LC-MS/MS. The R-enantiomer comprised 60-72% of 5-HETE, 18-58% of 15-HETE and 1-16% of 12-HETE in colonic mucosa, suggesting that non-LOX sources contribute to HETE profiles. Fish oil reduced levels of both R- and S-HETEs, and increased the preponderance of the R-enantiomers (particularly 12- and 15-HETEs). There was apparent shunting of arachidonic acid to12/15-LOX in the COX-1 null animals. This is the first report of the enantiomeric composition of HETEs in the colon in vivo.

Weight gain is an important concern that impacts on breast cancer outcomes and general health in survivorship. This randomized, pilot study evaluated whether or not women could comply with a weight control program that is initiated at the beginning of chemotherapy for breast cancer. The program sought to prevent weight gain using a low-fat, high fruit-vegetable diet combined with moderate physical activity. The intervention was implemented using a telephone counseling approach that blended motivational interviewing with social cognitive theory. A total of 40 women were recruited over 9 months at the University of Michigan Comprehensive Cancer Center. This represents 55% of eligible women referred to the study and indicates that interest in a healthy lifestyle program at the initiation of chemotherapy for breast cancer was high. Subjects who dropped out had significantly lower fruit and vegetable intakes and lower blood carotenoids at baseline than subjects who completed the study. Statistically significant beneficial effects were observed on fruit and vegetable intakes, physical activity and breast cancer-specific well-being by the intervention. Mean body fat from dual energy X-ray absorptiometry increased in the written materials arm and decreased in the intervention arm. Of the enrolled women, 75% completed 12 months on study and satisfaction with study participation was high. These data indicate that lifestyle intervention during breast cancer treatment is feasible during treatment with chemotherapy for breast cancer and benefits women in several domains.

Background

Benign proliferative breast disease without atypia slightly increases breast cancer risk but there are currently few clinical options for breast cancer prevention in this group of women.

Methods

We conducted a pilot study of women with a past diagnosis of proliferative breast disease with a goal to determine if the characteristics of cells obtained by breast ductal lavage were related to nutritional factors.

Results

There were 57 women who enrolled. A total of 39 women yielded nipple aspirate fluid (NAF) samples and 36 underwent breast ductal lavage. Five of the lavage samples were acellular and 28 had at least 200 cells. Surprisingly, atypia was present in 11 women. Presence of atypia was associated with slight changes in morphometric features of the epithelial cells such as measures of circularity) as obtained by image analysis, but the only variable significantly different in women with atypia (versus no atypia) was a higher mean body mass index. Body mass index also was significantly correlated with C-reactive protein (CRP) levels in the nipple aspirate fluid, indicating that obesity might have a pro-inflammatory effect on the breast that can contribute to increased rates of atypia.

Conclusions

Although the clinical significance of atypia in breast ductal lavage is uncertain, these results support further work on prevention of obesity as a strategy for reducing breast cancer risk.

Objective

This study examined the feasibility of eliciting dietary changes in subjects recruited from a diverse primary care setting in Michigan using a written, one-page plan, either alone or with telephone counseling.

Methods

A total of 96 subjects were enrolled from 9/28/06 to 5/7/07 (49% minorities). Subjects were randomized into three groups. Group 1 received written materials. Group 2 received written materials plus a one-page form that asked them to make a specific daily plan for substituting one less nutritious food with two servings of fruits and vegetables. Group 3 received the written materials, the one-page form and telephone counseling from a dietitian.

Results

Subject retention was 76% for the 12-week study. Subjects in Groups 1, 2 and 3 changed their mean intakes of fruit and vegetables by 0.4, −0.7 and 1.4 servings/day, respectively. Participants in Group 3 lost an average of 0.73 kg, increased their perception of the importance of eating fruits and vegetables, and 63% increased their serum levels of carotenoids by 20% or more.

Conclusion

Recruitment through a primary care clinic was effective. Formulation of a written plan combined with telephone counseling appears to be promising for improving fruit and vegetable intakes and warrants more definitive study.

This study examined patterns of changes in plasma fatty acids and carotenoids when women were asked to follow a novel, Greek-Mediterranean exchange list diet. A total of 69 healthy, non-obese, women ages 25–59, were randomized to either continue their own usual diet or to follow a modified Mediterranean diet for six months. There were no significant changes in blood lipids, triacylglycerol, insulin, glucose or C-reactive protein. Mean plasma carotenoids increased by 55%, which is consistent with a large increase in fruit and vegetable consumption. Likewise, changes in fat intakes were reflected in blood fatty acids, with a 25% increase in mean plasma monounsaturated fatty acids (MUFA). Principal component analysis was conducted to examine the sources of inter-individual variation for changes in carotenoid and fatty acid levels. Changes in the Mediterranean diet were clustered together in four components that accounted for 78% of the variance in plasma levels. Increases in plasma lutein, α- and β-carotene clustered together in a “vegetable” pattern, and increases in carotenoids found in fruit, β-cryptoxanthin and zeaxanthin, also clustered together but accounted for less of the variance. Increases in plasma MUFA were clustered with a decrease in plasma polyunsaturated fatty acids, consistent with substitution in the type of oils consumed. The only association of fatty acid levels with carotenoids was that of lycopene, which clustered together with an increase in saturated fatty acids. The changes in blood levels indicate the exchange list diet was effective for targeting Mediterranean nutrient intakes using foods available in the United States.