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Janssen A.M.,Wageningen University | Kremer S.,Wageningen University | van Stipriaan W.L.,Julius Clinical | van Stipriaan W.L.,Wageningen University | And 3 more authors.
Journal of the Academy of Nutrition and Dietetics | Year: 2015

Background: Processed foods are major contributors to excessive sodium intake in Western populations. We investigated the effect of food reformulation on daily dietary sodium intake. Objective: To determine whether uninformed consumers accept reduced-sodium lunches and to determine the effect of consuming reduced-sodium lunches on 24-hour urinary sodium excretion. Design: A single-blind randomized controlled pretest-posttest design with two parallel treatment groups was used. Participants/setting: Participants chose foods in an experimental real-life canteen setting at the Restaurant of the Future in Wageningen, the Netherlands, from May 16 until July 1, 2011. Intervention: After a run-in period with regular foods for both groups, the intervention group (n=36) consumed foods with 29% to 61% sodium reduction (some were partially flavor compensated). The control group (n=38) continued consuming regular foods. Main outcome measures: Outcomes for assessment of acceptance were the amount of foods consumed, energy and sodium intake, remembered food liking, and intensity of sensory aspects. Influence on daily dietary sodium intake was assessed by 24-hour urinary sodium excretion. Statistical analyses performed: Between and within-subject comparisons were assessed by analysis of covariance. Results: Energy intake and amount consumed of each food category per lunch remained similar for both groups. Compared with the control group, the intervention group's sodium intake per lunch was significantly reduced by -1,093 mg (adjusted difference) (95% CI -1,285 to -901), equivalent to 43 mmol sodium. Remembered food liking, taste intensity, and saltiness were scored similarly for almost all of the reduced-sodium foods compared with the regular foods. After consuming reduced-sodium lunches, compared with the control group, intervention participants' 24-hour urinary sodium excretion was significantly lower by -40 mEq (adjusted difference) (95% CI -63 to -16) than after consuming regular lunches, and this reflects a decreased daily sodium intake of 1 g. Conclusions: Comparing the two treatment groups, consumption of reduced-sodium foods over a 3-week period was well accepted by the uninformed participants in an experimental real-life canteen setting. The reduced-sodium foods did not trigger compensation behavior during the remainder of the day in the intervention group compared with the control group, as reflected by 24-hour urinary sodium excretion. Therefore, offering reduced-sodium foods without explicitly informing consumers of the sodium reduction can contribute to daily sodium intake reduction. © 2015 Academy of Nutrition and Dietetics.

Bonten M.J.M.,University Utrecht | Huijts S.M.,University Utrecht | Bolkenbaas M.,University Utrecht | Webber C.,Pfizer | And 25 more authors.
New England Journal of Medicine | Year: 2015

Background Pneumococcal polysaccharide conjugate vaccines prevent pneumococcal disease in infants, but their efficacy against pneumococcal community-acquired pneumonia in adults 65 years of age or older is unknown. Methods In a randomized, double-blind, placebo-controlled trial involving 84,496 adults 65 years of age or older, we evaluated the efficacy of 13-valent polysaccharide conjugate vaccine (PCV13) in preventing first episodes of vaccine-type strains of pneumococcal community-acquired pneumonia, nonbacteremic and noninvasive pneumococcal community-acquired pneumonia, and invasive pneumococcal disease. Standard laboratory Methods and a serotype-specific urinary antigen detection assay were used to identify community-acquired pneumonia and invasive pneumococcal disease. Results In the per-protocol analysis of first episodes of infections due to vaccine-type strains, community-acquired pneumonia occurred in 49 persons in the PCV13 group and 90 persons in the placebo group (vaccine efficacy, 45.6%; 95.2% confidence interval [CI], 21.8 to 62.5), nonbacteremic and noninvasive community-acquired pneumonia occurred in 33 persons in the PCV13 group and 60 persons in the placebo group (vaccine efficacy, 45.0%; 95.2% CI, 14.2 to 65.3), and invasive pneumococcal disease occurred in 7 persons in the PCV13 group and 28 persons in the placebo group (vaccine efficacy, 75.0%; 95% CI, 41.4 to 90.8). Efficacy persisted throughout the trial (mean follow-up, 3.97 years). In the modified intention-totreat analysis, similar efficacy was observed (vaccine efficacy, 37.7%, 41.1%, and 75.8%, respectively), and community-acquired pneumonia occurred in 747 persons in the PCV13 group and 787 persons in placebo group (vaccine efficacy, 5.1%; 95% CI,-5.1 to 14.2). Numbers of serious adverse events and deaths were similar in the two groups, but there were more local reactions in the PCV13 group. Conclusions Among older adults, PCV13 was effective in preventing vaccine-type pneumococcal, bacteremic, and nonbacteremic community-acquired pneumonia and vaccinetype invasive pneumococcal disease but not in preventing community-acquired pneumonia from any cause. © 2015 Massachusetts Medical Society. All rights reserved.

Smorenburg A.J.,Julius Clinical | Oosterman B.J.,Julius Clinical | Grobbee D.E.,Julius Clinical | Grobbee D.E.,University Utrecht | And 2 more authors.
Vaccine | Year: 2014

Large-scale randomized studies generate the highest level evidence for medical interventions. Yet, successful recruitment frequently is challenging, especially when targeting elderly populations. Although several studies investigated specific recruitment barriers, there is little quantitative understanding of such barriers. We therefore determined associations between patient related and study-related factors and study inclusion in healthy elderly (>65 years) invited to participate in a double-blind placebo-controlled randomized study to determine effectiveness and safety of a 13-valent pneumococcal vaccine for community-acquired pneumonia in the Netherlands. Inclusions for this study took place between September 2008 and January 2010. The analysis was performed on replies to invitations sent between February 2009 and October 2009. In our analyses 260,700 replies from this period resulted in 48,982 candidates included in the study (18.8%). Study inclusion was associated with travel time to the vaccination site (decline of 0.6% per 4. min travel time, adjusted odds ratio (OR) 0.972, 95% CI 0.964-0.980), number of published advertorials in local newspapers (increase of 0.4% per consecutively placed advertorial, adjusted OR 1.030, 95% CI 1.026-1.035), age (decline of 0.7% per year, adjusted OR 0.953, 95% CI 0.951-0.955) and male gender (adjusted OR 0.588 versus female, 95% CI 0.576-0.599). Introduction letters sent on behalf of general practitioners prior to the actual invitation letter were not associated with study inclusion. Careful consideration of these parameters in study preparation may facilitate more successful patient recruitment in clinical trials in healthy elderly. © 2014 Elsevier Ltd.

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