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Background: The high frequency of outpatient visits after kidney transplantation is burdensome to both the recovering patient and health care capacity. Self-monitoring kidney function offers a promising strategy to reduce the number of these outpatient visits. Objective: The objective of this study was to investigate whether it is safe to rely on patients’ self-measurements of creatinine and blood pressure, using data from a self-management randomized controlled trial. Methods: For self-monitoring creatinine, each participant received a StatSensor Xpress-i Creatinine Meter and related test material. For self-monitoring blood pressure, each participant received a Microlife WatchBP Home, an oscillometric device for blood pressure self-measurement on the upper arm. Both devices had a memory function and the option to download stored values to a computer. During the first year post transplantation, 54 patients registered their self-measured creatinine values in a Web-based Self-Management Support System (SMSS) which provided automatic feedback on the registered values (eg, seek contact with hospital). Values registered in the SMSS were compared with those logged automatically in the creatinine device to study reliability of registered data. Adherence to measurement frequency was determined by comparing the number of requested with the number of performed measurements. To study adherence to provided feedback, SMSS-logged feedback and information from the electronic hospital files were analyzed. Results: Level of adherence was highest during months 2-4 post transplantation with over 90% (42/47) of patients performing at least 75% of the requested measurements. Overall, 87.00% (3448/3963) of all registered creatinine values were entered correctly, although values were often registered several days later. If (the number of) measured and registered values deviated, the mean of registered creatinine values was significantly lower than what was measured, suggesting active selection of lower creatinine values. Adherence to SMSS feedback ranged from 53% (14/24) to 85% (33/39), depending on the specific feedback. Conclusions: Patients’ tendency to postpone registration and to select lower creatinine values for registration and the suboptimal adherence to the feedback provided by the SMSS might challenge safety. This should be well considered when designing self-monitoring care systems, for example by ensuring that self-measured data are transferred automatically to an SMSS.

The aim of the study was to test the hypothesis that daily administration of growth hormone using the Medi-Jector® results in fewer adverse psychological responses than needle injection with a multidose injection pen. The Medi-Jector is a needle-free injection device that can deliver growth hormone subcutaneously through jet injection. The group studied consisted of 18 children aged 10 y or over who were participating in a study of the bioequivalence and bioequipotence of the administration of growth hormone through jet injection or needle injection. Previously, all subjects had received growth hormone therapy with commercially available multidose injection pens. The study was designed as a prospective, randomized, two-period cross-over trial. A questionnaire was used to assess psychological responses such as non-compliance, opinion on ease of preparation, affective responses to administration and local side-effects, as well as overall preference. In addition, the subjects kept a diary during the study. The subjects found the Medi-Jector less offputting (p < 0.01), less painful with respect to both frequency (p < 0.04) and intensity (p < 0.01) and less unpleasant (p < 0.05) than a multidose injection pen with a 28G needle (p < 0.01). No difference in compliance was detected. Most subjects preferred the Medi-Jector for future use (p < 0.05). The mean score on a 1- 10 point scale (10 is excellent) was 7.9 (SD 1.4) for the Medi-Jector and 6.8 (SD 2.3) for the multidose injection pen (p < 0.08). The prevalence of visible bruises each day was higher (p < 0.01) with the Medi-Jector (2.5, SD 2.1) than with the multidose injection pen (0.7, SD 1.1), but children showed indifferent affective responses to bruising. Thirteen out of 18 subjects decided to continue therapy with the Medi-Jector (p < 0.06). It is concluded that use of the Medi-Jector in growth hormone therapy tends to lead to fewer adverse psychological responses than a multidose injection pen with 28G needles.

Periconceptional folic acid use considerably reduces the risk of neural tube defects. The aim of this study was to measure the effect of the national and the local 'Folic Acid Campaign' on periconceptional folic acid use. Before (1995 survey) and 1 year after the campaign (1996 survey), the awareness and use of folic acid was measured among pregnant women in four regions of the Netherlands. To this end, pregnant women who visited the midwife, general practitioner or obstetrician for the first or second prenatal visit were asked to complete a questionnaire. The results showed that use of folic acid for any period around conception increased from 25.1% in 1995 to 53.5% in 1996. Appropriate use (4 weeks before until 8 weeks after conception) increased from 4.8% in 1995 to 21.0% in 1996. No additional effect of the local Folic Acid Campaign was found (adjusted odds ratio = 1.0; 95% confidence interval = 0.7, 1.4). It was possible to conclude that folic acid use at the recommended time increased considerably as a result of the national and the local Folic Acid Campaign, but the target (use in 46% of women wishing to conceive) was not achieved. New health education programmes are needed to increase further its use at the appropriate times.

Allium vegetables (onions, leeks, chives) and in particular garlic have been claimed to have health-promoting potential. This study was conducted to get insight into the perspectives for monitoring the intake of garlic by a biomarker approach. Chemically, the bimarker results from exposure to γ-glutamyl-S-allyl-L-cysteine, which is first hydrolysed by γ-glutamine-transpeptidase resulting in the formation of S-allyl-L-cysteine. The latter compound is subsequently N-acetylated by N-acetyltransferase into S-allyl-mercapturic acid (ALMA) and excreted into urine. The mercapturic acid was measured in urine using gaschromatography with mass spectrometry. Thus the intake of garlic was determined to check the compliance of garlic intake in placebo-controlled intervention study. Results indicate that S-allyl-mercapturic acid could be detected in 15 out of 16 urine samples of garlic supplement takers, indicating good compliance. In addition, the intake of garlic was also monitored in a cross-section study of vegans versus controls in Finland, in which no differences in garlic consumption nor in ALMA output were recorded between vegans and controls. These data indicate good possibilities for further studies in the field of biomarkers to investigate the putative chemopreventive effects of garlic and garlic-containing products. Chemicals/CAS: Acetylcysteine, 616-91-1; Antioxidants; Biological Markers

Objective: To examine the effects of aerobic exercise or vitamin B supplementation on cognitive function in older adults with mild cognitive impairment (MCI). Design: Randomised placebo-controlled trial. Setting: General community. Participants: Community-dwelling adults aged 70-80 with MCI. Interventions : The 152 participants were randomly assigned to two interventions: (1) a twice-weekly, group-based, moderate-intensity walking programme (WP, n = 77) or a low-intensity placebo activity programme (n = 75) for one year; and (2) daily vitamin pill containing 5 mg folic acid, 0.4 mg vitamin B-12, 50 mg vitamin B-6 (FA/B12/B6, n = 78) or placebo pill (n = 74) for one year. Outcome measures: Cognitive function, measured with neuropsychological tests at baseline and after six and 12 months. Results: Median session attendance at the exercise programmes (25th-75th percentile) was 63% (2%-81%) and median compliance with taking pills (25th-75th percentile) was 100% (99%-100%). Gender was an effect modifier. Intention-to-treat analysis revealed no main intervention effect for either intervention. In women in the WP, attention (Stroop combination task) improved by 0.3 seconds (p = 0.04) and memory (auditory verbal learning test) by 0.04 words (p = 0.06) with each percentage increase in session attendance. In men attending at least 75% of the sessions, the WP improved memory (β 1.5 (95% CI: 0.1 to 3.0) words). Conclusion: The walking programme and/or FA/B12/B6 supplementation were not effective in improving cognition within one year. The walking programme, however, was efficacious in improving memory in men and memory and attention in women with better adherence. Trial registration: International Standard Randomised Controlled Trial Number Register, 19227688, http://www.controlled-trials.com/isrctn/. Chemicals / CAS: Folic Acid, 59-30-3; Vitamin B 12, 68-19-9; Vitamin B 6, 8059-24-3

Poor adherence to inhaled corticosteroids (ICSs) may contribute to the recent rise in asthma morbidity. In general, appropriate adherence to ICSs is a complex process that is influenced by various determinants. The purpose of this study was to identify factors that were associated with adherence to ICSs in children with asthma and their parents in a multi-ethnic population in Amsterdam, the Netherlands. Two hundred and thirty-two children, aged 7-17 years, with paediatrician diagnosed asthma and their parents completed questionnaires examining socio-demographics, asthma control, knowledge of asthma and other determinants of adherence. Adherence to ICSs was assessed by self-report and pharmacy record data. We used logistic regression analyses to identify factors associated with adherence to ICSs in children and parents separately. We found no differences in adherence between the different ethnic groups. In the multivariate analysis for children, well-controlled asthma (OR: 4.12; CI: 1.50-11.3) was associated with poorer adherence, whereas positive subjective view of parents (OR: 0.45; CI:0.25-0.81) and self-efficacy (OR:0.51; CI: 0.35-0.75) were inversely associated with poorer adherence. A consistent result with the multivariate models for parents was the inversely significant association between poorer adherence and positive subjective view of parents to use ICSs (OR: 0.39; CI:0.19-0.77). Regardless of ethnic background, children positively stimulated by their parents to use ICSs showed a better adherence than children who experienced less positive influences. These results emphasise the importance of involving parents in the treatment of their child's asthma in order to enhance adherence to ICSs. © 2008 Elsevier Ltd. All rights reserved

Objective - To assess the relative contribution of patient and care provider characteristics to the adherence of general practitioners (GPs) and midwives to two specific recommendations in the Dutch national guidelines on imminent miscarriage. The study focused on performing physical examinations at the first contact and making a follow up appointment after 10 days because these are essential recommendations and there was much variation in adherence between different groups of providers. Design - Prospective recording by GPs and midwives of care provided for patients with symptoms of imminent miscarriage. Setting - General practices and midwifery practices in the Netherlands. Subjects - 73 GPs and 38 midwives who agreed to adhere to the guidelines; 391 patients were recorded during a period of 12 months. Main measures - Adherence to physical examinations and making a follow up appointment were measured as part of a larger prospective recording study on adherence to the guidelines on imminent miscarriage. Patient and care provider characteristics were obtained from case recordings and interviews, respectively. Multilevel analysis was performed to assess the contribution of several care provider and patient characteristics to adherence to two selected recommendations: the number of recommended physical examinations at the first contact and the number of days before a follow up appointment took place. Results -In the multilevel model explaining variance in adherence to physical examinations, the care provider's acceptance of the recommendations was the most important factor. Severity of symptoms and referral to an obstetrician were significant factors at the patient level. In the model for follow up appointments the characteristics of the care provider were less important. Referral to an obstetrician and probability diagnosis were significant factors at the patient level. Conclusions - The study showed that characteristics of both the patient and care provider contribute to the variability in adherence. Furthermore, the contribution of the characteristics differed per recommendation. It is therefore advised that the contribution of both patient and care provider characteristics per recommendation should be carefully examined. If implementation is to be successful, strategies should be developed to address these specific contributions.

Background. The objective of this study was to determine the importance of parental factors possibly related to dietary control in early and continuously treated patients with phenylketonuria (PKU). Methods. A questionnaire was disseminated among parents of 238 patients with PKU born after the nationwide introduction of newborn screening for PKU (1 September 1974) until 31 December 1995. The questionnaire was based on a behavioural model measuring people's attitudes, subjective norms, and self-efficacy. Dietary control was defined on the basis of mean phenyl-alanine (Phe) concentration of the PKU patients measured between 1 January 1994 and 31 December 1996. Results. Response rate was 71%. Attitudes: children of parents who believed that their child adheres well to the diet, even if his or her Phe concentrations are sometimes too high, had lower Phe concentrations than children of parents who disagree with this statement (adjusted difference -103 μmol/L, p < 0.001). Subjective norm: Phe concentrations were higher when parents answered that their relatives did not approve when their child deviates from the diet (p = 0.004). Self-efficacy: children of parents who reported difficulties in having their child eat the synthetic protein substitute three times a day had higher Phe concentrations than those of parents who did not have such difficulties (adjusted difference 156 μmol/L, p = 0.007). Conclusion. More attention should be given to parents having their child eat the synthetic protein substitute at least three times a day and to teaching parents to keep strictly to the diet without being too rigid. These factors were strongly associated to dietary control and may be amenable to change. © SSIEM and Springer 2005. Chemicals / CAS: phenylalanine, 3617-44-5, 63-91-2; protein, 67254-75-5; Phenylalanine, 63-91-2

Aims: This study was undertaken to estimate the effect of hip protectors on the incidence of hip fracture when introduced into nursing homes as a regular part of the healthcare for all residents. Methods: A pre-test/test design was used. The pre-intervention period lasted 18 months from May 1996. The intervention period lasted 18 months from May 1998. During the intervention period all residents (965 beds) in nursing homes in two municipalities in Norway were offered free use of hip protectors. The project manager provided motivational activities in the nursing homes during the whole period, aimed at increasing the participation rate. Results: The intervention period showed a 39% reduction in the hip fracture incidence when compared with the pre-intervention period (p = 0.003). The percentage of daily users of the protector varied from 35% during the first months to 22% at the end of the period. Among the 61 persons who suffered a hip fracture 31 were registered as daily users. Fourteen of the 31 users were not wearing the protector when the hip fracture occurred, while five of the 31 had the protector on their knees. Twelve of the 31 suffered a hip fracture while properly wearing the protector. Conclusions: This non-randomized study showed that hip protectors introduced to all residents in nursing homes considerably reduced the incidence of hip fracture. It may be possible to achieve higher compliance and a further reduction in the incidence of hip fractures if the producers of hip protectors increase the comfort of the protector without reducing its effect. In addition, it is important that health workers encourage more individuals at high risk to use the protector. © Taylor & Francis 2003.

Introduction: Workers with chronic low back pain (LBP) mean a heavy human and social-economic burden. Their medical histories often include different treatments without attention to work-relatedness or communication with occupational health providers, leaving them passive and medicalized in (outpatient) health care. So we developed and implemented an innovative, patient-activating alternative: the multidisciplinary outpatient care (MOC) programme, including work(place) intervention and graded activity. It aims at function restore (instead of pain elimination), return to work (RTW) and coordinated communication. Objectives: To qualitatively explore how patients and health care providers perceive the programme effectiveness and which factors influence its implementation. Methods: In-depth, semi structured interview with patients and focus groups of health care providers are used, all recorded, transformed into verbatim transcript and analysed. Results: This qualitative study shows that although patients' expectations were low at the start of the program, and despite long LBP histories, including many different therapies, (primarily) directed at pain reduction, the MOC programme was successful in changing patients' goal setting from pain oriented towards function restore and RTW. The programme was therefore perceived as applicable and effective. Patient compliance was influenced by barriers - despair, supervisory and subordinate resistance at work, waiting period, medicalisation in health care - and facilitators: disciplinary motivation, protocolled communication, information supply, tailor-made exercises. For some patients the barriers were too high. Several improvement suggestions were given. Conclusions: This qualitative study shows that generally, patients and professionals perceived the multidisciplinary outpatient care programme as applicable and effective. After incorporating improvement suggestions this program seems promising for further, broader application and hypothesis testing. For those, negatively evaluating the programme, alternatives should be explored. © 2009 IOS Press. All rights reserved.

OBJECTIVE. Mass screening for celiac disease is controversial. The objective of this study was to determine whether detection of childhood celiac disease by mass screening improves long-term health status and health-related quality of life. METHODS.We conducted a prospective 10-year follow-up study of 32 children who were aged 2 to 4 years, had celiac disease identified by mass screening, and had a gluten-free diet (19) or a normal gluten-containing diet (13). The follow-up included assessments of general health status, celiac disease-associated symptoms, celiac disease-associated serum antibodies, and health-related quality of life. RESULTS. Ten years after mass screening, 81% of the children were adhering to a gluten-free diet. The health status improved in 66% of the treated children: in 41% by early treatment and in 25% by prevention of the gluten-dependent symptoms that they developed after diagnosis. For 19% of the children, treatment after screening would not have improved their health status, because they had no symptoms at screening and have remained symptom-free while consuming gluten. The healthrelated quality of life of the children with symptoms improved significantly after 1 year of gluten-free diet. Ten years after screening, the health-related quality of life of the children with celiac disease was similar to that of the reference population. CONCLUSION. Identification by mass screening led 10 years later to health improvement in 66% of children without deterioration of generic health-related quality of life. There is a good compliance after mass screening. In a research setting, delaying treatment for children without symptoms seems to be an option after a positive screening test. Long-term follow-up studies are needed to assess possible long-term complications in untreated, nonsymptomatic celiac disease. Copyright © 2009 by the American Academy of Pediatrics.

Background: New strategies are required to optimize care in increasing numbers of chronic heart failure patients. The aim of this randomised trial was to evaluate a remote guidance system. Methods: Intervention group patients received a home TV-channel providing educational materials. Tele-guidance was performed by a Medical Service Centre. Control group patients were followed by cardiologists and HF-nurses. Primary endpoints were total days in hospital for all causes and days alive and out of hospital. Secondary endpoints were: quality of life and knowledge of disease and self care. Results: 214 patients were enrolled, median age was 66 years, 89% had systolic LV dysfunction, and 90% were in NYHA class II or III. The mean LVEF was 31%. Over a mean follow-up duration of 288 days, there were 199 hospital admissions in 105 patients. Comparison of the groups revealed no differences for the primary outcomes or for QoL or self care behaviour. Knowledge about heart failure however, increased significantly more in the Intervention group (p < 0.001). Conclusion: Tele-guidance may play a role in the management of heart failure patients since it takes over some of the tasks of HF-nurses. This may facilitate delivery of optimal care to more patients with the same level of experienced staff. © 2008 European Society of Cardiology.

A proof-of-concept study to assess the safety and efficacy of a traditional Chinese medicine formula as treatment for primary dysmenorrhea showed no statistically significant benefit over placebo. However, some efficacy parameters suggested possible superiority of the active treatment and so a larger study needs to be performed to determine whether this remedy has a role in the treatment of dysmenorrhea. © 2006 American Society for Reproductive Medicine.

The estrogenic effects of soy isoflavones (IF) on symptoms of menopause are of particular interest. The aim of the present study was to improve compliance of IF in two IF-enriched foods providing the same IF circulating levels in postmenopausal women. Forty-two healthy postmenopausal women (mean age: 53.28 years) were recruited for a randomized, crossover, multicenter trial conducted in the Netherlands, Italy and France. Over 18 days, volunteers were assigned to two groups and supplemented with two different IF-enriched foods (100 mg IF aglycones/two servings). The first group had to eat two biscuits daily for three days. After a wash-out period (11 d), they received cereal bars for three days. The second group started with the cereal bars and finished with biscuits. After IF intake, plasma and urinary levels of genistein, daidzein, O desmethyl angolensin and equol significantly increased and returned to baseline level after the washout period. There was no difference between biscuits and cereals bars intake, as shown by group values at each end of experimental period (day 4 or day 18). Both matrixes are comparable in terms of IF-circulating levels and could be used independently. © 2008 Chanteranne et al, publisher and licensee Dove Medical Press Ltd.

Background. Doctors and patients hold varying beliefs concerning illness and treatment. Patients' and families' explanatory models (EMs) vary according to personality and sociocultural factors. In a multi-ethnic society, it is becoming increasingly significant that doctors understand the different beliefs of their patients in order to improve patient/doctor communication as well as patient adherence to treatment. Methods. Twelve focus groups were formed, consisting of 40 children diagnosed with asthma, as well as 28 mothers of these children. These groups included mothers and children of different ethnicities who were living in Amsterdam, the Netherlands. In order to understand the beliefs that both mothers and children hold regarding asthma and its treatment, the explanatory models were analysed and compared. Results. Study findings show that mothers and children, regardless of ethnicity and age, have their own EMs. Overall, there is a great deal of uncertainty related to the causes, consequences, problems, and symptoms of asthma and its treatment. It also seems that many concerns and feelings of discomfort are the result of lack of knowledge. For instance, the fact that asthma is not seen as a chronic disease requiring daily intake of an inhaled corticosteroid, but rather as an acute phenomenon triggered by various factors, may be very relevant for clinical practice. This particular belief might suggest an explanation for non-adherent behaviour. Conclusion. A thorough understanding of the mothers' and children's beliefs regarding the illness and its treatment is an important aspect in the management of asthma. Gaining an understanding of these beliefs will provide a foundation for a solid clinician-patient/family partnership in asthma care. Although ethnic differences were observed, the similarities between the mothers' and children's beliefs in this multi-ethnic population were striking. In particular, a common belief is that asthma is considered an acute rather than a chronic condition. In addition, there is a lack of knowledge about the course and the self-management of asthma. Health care providers should be aware of these commonly held beliefs, and this information could be shared in educational programs. © 2008 van Dellen et al; licensee BioMed Central Ltd. Chemicals / CAS: salbutamol, 18559-94-9

Elderly participants experiencing difficulty in chair rising and with a maximum knee-extensor torque below 87.5 N · m were randomized to different versions of a strength-training program for the knee-extensors: to a high-guidance group (HG; two group sessions supervised by a physical therapist and one unsupervised home session per week, n = 17), a medium-guidance group (MG; one supervised group session and two unsupervised home sessions per week, n = 16), or a control group (C; no exercise, n = 16). Maximal isometric knee strength increased more in HG than in C (p = .03) and with increasing guidance (p = .03). The effect was mainly the result of participants with low initial strength. Walking speed increased more for HG than for C (p = .02) and than for MG (p = .06). No statistically significant improvements were seen on other functional tests. In summary, the study shows a trend toward better results with more supervision, but more and larger studies are needed to confirm this.

Objective: : The effectiveness of use of migrant health educators in the general practitioners' care for female migrants with psychosomatic problems was evaluated to contribute to the improvement of the care for these patients. Methods: : A randomised controlled trial (RCT) design was used. A total of 104 patients (75%) agreed to take part in the intervention study. The patients were from Turkish and Moroccan immigrant groups living in The Netherlands. The intervention group received counselling and education from the migrant health educators as adjuncts to the GPs' care. Special attention was given to the patient's cultural background, supporting the communication between GP and patient. The control group received regular treatment from their GPs. Results: : A significant improvement of perceived general health, psychological health and reported ability to cope with pain was observed among the intervention group. No effects were found for social support and the perceived burden of stressful life-events. Conclusion: : The patients' perceived health and coping abilities improved through the intervention as a whole. Not all outcome measures had been affected due to among others the diversity of physical and psychological complaints the patients suffered from, non-compliance and a perceived decrease of disability over time. Practice implications: : The intervention methods should be integrated in the patient care delivery for migrants in general practice. Further development of intervention methods to address the patients' social support is recommended. © 2007 Elsevier Ireland Ltd. All rights reserved.

Objectives: To examine the effect of walking and vitamin B supplementation on quality-of-life (QoL) in community-dwelling adults with mild cognitive impairment. Methods: One year, double-blind, placebo-controlled trial. Participants were randomized to: (1) twice-weekly, group-based, moderate-intensity walking program (n = 77) or a light-intensity placebo activity program (n = 75); and (2) daily vitamin B pills containing 5 mg folic acid, 0.4 mg B12, 50 mg B6 (n = 78) or placebo pills (n = 74). QoL was measured at baseline, after six and 12 months using the population-specific Dementia Quality-of-Life (D-QoL) to assess overall QoL and the generic Short-Form 12 mental and physical component scales (SF12-MCS and SF12-PCS) to assess health-related QoL. Results: Baseline levels of QoL were relatively high. Modified intention-to-treat analyses revealed no positive main intervention effect of walking or vitamin supplementation. In both men and women, ratings of D-QoL-belonging and D-QoL-positive affect subscales improved with 0.003 (P = 0.04) and 0.002 points (P = 0.06) with each percent increase in attendance to the walking program. Only in men, SF12-MCS increased with 0.03 points with each percent increase in attendance (P = 0.08). Conclusion: Several small but significant improvements in QoL were observed with increasing attendance to the walking program. No effect of vitamin B supplementation was observed. Trial Registration: International Standard Randomized Controlled Trial Number Register, 19227688, http://www.controlled-trials.com/isrctn/. © 2007 Springer Science+Business Media B.V.

Background: Epidemiologic studies suggest that garlic may have beneficial effects on risk factors associated with cardiovascular disease (CVD). However, these findings are not unambiguously supported by randomized placebo-controlled clinical trials. Objective: We sought to investigate the effects of a chemically well-characterized garlic preparation on biomarkers for inflammation, endothelial function, and lipid metabolism in subjects with risk factors for CVD. Design: This was a double-blind, randomized, placebo-controlled trial in 90 overweight [body mass index (in kg/m2) > 24.5] subjects aged 40-75 y who smoked >10 cigarettes/d. The subjects were randomly assigned to 3 parallel treatment groups: garlic powder (2.1 g/d), atorvastatin (40 mg/d), or placebo. Duplicate measurements were performed at baseline and after 1 and 3 mo of treatment. Treatments were compared with analysis of covariance with baseline as the covariate, and differences between the treatments were reported as mean percentage difference and corresponding 97.5% CI. Results: None of the variables showed significant differences between the garlic-treated and the placebo groups. In contrast, compared with the placebo group, atorvastatin treatment resulted in significantly lower plasma concentrations of C-reactive protein (20.2%; 1.7%, 35.3%), total cholesterol (37.2%; 33.1%, 41.1%), LDL cholesterol (52.7%; 47.9%, 57.1%), triacylglycerols (31.9%; 20.8%, 41.5%), and tumor necrosis factor α (TNF-α; 41.9%; 19.0%, 58.3%) and increased the ratio of ex vivo whole blood lipopolysaccharide-stimulated to nonstimulated TNF-α concentrations (109.7%; 37.9%, 218.9%). Conclusion: We conclude that a chemically well-characterized garlic preparation has no significant effect on inflammatory biomarkers, endothelial function, or lipid profile in normolipidemic subjects with risk factors for CVD. © 2006 American Society for Nutrition. Chemicals / CAS: atorvastatin, 134523-00-5, 134523-03-8; C reactive protein, 9007-41-4; Anticholesteremic Agents; atorvastatin, 110862-48-1; Biological Markers; C-Reactive Protein, 9007-41-4; Cholesterol, 57-88-5; Cholesterol, HDL; Cholesterol, LDL; Heptanoic Acids; Lipids; Plant Extracts; Powders; Pyrroles; Triglycerides

Excessive consumption of energy and fat increases the risk for obesity. Snacks containing sucrose polyesters (SPE) as a dietary fat replacer are on the market in the United States. SPE products have been shown to lower concentrations of serum carotenoids in short-term studies. Experimental studies on the longer-term effects on health of decreased carotenoid concentrations are lacking. A 1-y randomized, double-blind, placebo-controlled parallel trial was performed. Subjects (n = 380) with a habitual low or high fruit and vegetable intake were assigned to the treatments (0, 7, 10 or 17 g/d SPE). SPE was given in the form of spreads, chips or both. The groups were compared for serum carotenoids, vitamins and markers of oxidative damage, eye health, cardiovascular health and immune status. After 1 y, serum lipid-adjusted carotenoids showed the largest decrease in the SPE chips and spread group (17 g/d) compared with the control group [α-carotene 33%; β-carotene 31%, lycopene 24%, β-cryptoxanthin 18%, lutein 18% (all P < 0.001) and zeaxanthin 13% (P < 0.05)]. Consumption of SPE spread (10 g/d SPE) decreased carotenoid concentrations by 11-29% (all P < 0.05). SPE chips (7 g/d SPE) decreased zeaxanthin (11%), β-carotene (12%) and α-carotene (21%; all P < 0.05). Serum lipid adjusted α-tocopherol decreased significantly by 6-8% (all P < 0.001) in all SPE groups. No negative effects were observed on markers of oxidation, eye health, cardiovascular health or immune status. This study shows that decreases in serum carotenoid concentrations do not affect possible markers of disease risk.