Anti-inflammatory effect of virgin olive oil in stable coronary disease patients: a randomized, crossover, controlled trial

OBJECTIVES: To assess the effect of two similar olive oils, but with differences in their phenolic compounds (powerful antioxidant compounds), on inflammatory markers in stable coronary heart disease patients. DESIGN: Placebo-controlled, crossover, randomized trial. SETTING: Cardiology Department of Hospital del Mar and Institut Municipal d'Investigació Mèdica (Barcelona). SUBJECTS: Twenty-eight stable coronary heart disease patients. INTERVENTIONS: A raw daily dose of 50 ml of virgin and refined olive oil (ROO) was sequentially administered over two periods of 3-weeks, preceded by 2-week washout periods in which ROO was used.Results:Interleukin-6 (P<0.002) and C-reactive protein (P=0.024) decreased after virgin olive oil intervention. No changes were observed in soluble intercellular and vascular adhesion molecules, glucose and lipid profile. CONCLUSIONS: Consumption of virgin olive oil, could provide beneficial effects in stable coronary heart disease patients as an additional intervention to the pharmacological treatment.     

Different gene expression profiles in normo- and dyslipidemic men after fish oil supplementation: results from a randomized controlled trial

ABSTRACT: BACKGROUND: Epidemiological studies have suggested the benefits of omega-3 polyunsaturated fatty acids (n-3 PUFAs) on cardiovascular health, but only limited data are available describing n-3 PUFA regulated pathways in humans. The aim of this study was to investigate the effects of n-3 PUFA administration on whole genome expression profiles in the blood of normo- and dyslipidemic subjects. METHODS: Differentially expressed genes were detected after four hours, one week and twelve weeks of supplementation with either fish oil (FO) or corn oil in normo- and dyslipidemic men using whole genome microarrays. RESULTS: Independent of the oil, a significantly higher number of genes was regulated in dyslipidemic subjects compared to normolipidemic subjects. Pathway analyses discovered metabolisms dominantly affected by FO after twelve weeks of supplementation, including the lipid metabolism, immune system and cardiovascular diseases. Several pro-inflammatory genes, in particular, were down-regulated in dyslipidemic subjects, indicating the immune-modulatory and anti-inflammatory capability of FO and its bioactive FAs, eicosapentaenoic acid and docosahexaenoic acid. CONCLUSIONS: This is the first study showing significant differences in gene expression profiles between normo- and dyslipidemic men after FO supplementation. Further studies need to clarify the exact role of n-3 PUFAs in pathways and metabolisms which were identified as being regulated after FO supplementation in this study.Trial registrationClinicalTrials.gov (ID: NCT01089231).     

A double-blind, randomized, controlled crossover trial of glutamine supplementation in home parenteral nutrition

OBJECTIVE: Studies suggest clinical benefit of glutamine-supplemented parenteral nutrition. The aim was to determine if the inclusion of 10 g of glutamine as part of the nitrogen source of home parenteral nutrition (HPN) reduces infectious complications. SUBJECTS/METHODS: Thirty-five patients on HPN were recruited and 22 completed the study. Patients were randomized to receive either standard HPN or glutamine-supplemented HPN. Patients were assessed at randomization, 3 and 6 months later then they were crossed over to the alternative HPN and reassessed at 3 and 6 months. Assessments included plasma amino acid concentrations, intestinal permeability and absorption, nutritional status, oral and parenteral intake, quality of life, routine biochemistry and haematology. RESULTS: No difference was seen between the groups at randomization. No difference was detected between the treatment phases for infective complications (55% in the standard treatment phase and 36% in the glutamine-supplemented phase P=0.67). There were no differences in nutritional status, intestinal permeability, plasma glutamine concentrations or quality of life. CONCLUSION: Although limited by the sample size, the study has shown that glutamine as part of the nitrogen source of parenteral nutrition can be given to patients on HPN for 6 months without any adverse effects.     

Regular aerobic exercise increases dispositional mindfulness in men: A randomized controlled trial

Dispositional mindfulness is a construct described as the propensity to be aware of one's actions in everyday life. Although high dispositional mindfulness has been demonstrated to be beneficial for improved mental and physical health, little is known about ways to improve dispositional mindfulness for individuals not practicing meditation or mindful exercises. The study aimed at investigating (1) whether dispositional mindfulness can also be trained by regular aerobic exercise and (2) whether changes in dispositional mindfulness are associated with changes in mental and physical health. 149 healthy men were randomly allocated to one of two 12-week interventions (aerobic exercise or relaxation training) or a waitlist control condition. Dispositional mindfulness and mental and physical health were assessed before and after the intervention by self-report questionnaires. Over the course of the intervention, increases in dispositional mindfulness occurred in the aerobic exercise group but not in the relaxation or waitlist control conditions (p = .018). Increases in dispositional mindfulness were moderately correlated with improvements in mental health. For the first time, this study shows that dispositional mindfulness can be increased through regular aerobic exercise. Future research is needed to identify how the mindfulness-enhancing potential of aerobic exercise can be used most effectively.     

A randomized controlled trial of an interactive Web-based intervention for reducing alcohol consumption

In an uncontrolled pilot study of an interactive, Web-based treatment programme for people with alcohol problems, the mean number of units consumed decreased from 33 per week to 23. A two-arm online randomized controlled trial will be conducted to determine the effectiveness of an interactive Web-based intervention for reducing alcohol consumption. Participants will be randomized to intervention (access to an interactive Web-based intervention plus information) or control (access to an information Web-site only) groups, and followed up for six months. The primary outcome measure will be reduction in units of alcohol consumed in the previous seven days; secondary outcome measures will determine effects on alcohol dependence, alcohol-related harm and social disruption and quality of life. Recruitment, consent, randomization, intervention and follow-up will all be delivered on-line.     

A randomized controlled trial of smoking cessation counseling after myocardial infarction

BACKGROUND: Smoking cessation after myocardial infarction (MI) has been associated with a 50% reduction in mortality but in-hospital smoking cessation interventions are rarely part of routine clinical practice. METHODS: One hundred cigarette smokers consecutively admitted during 1996 with MI were assigned to minimal care or to a hospital-based smoking cessation program. Intervention consisted of bedside cessation counseling followed by seven telephone calls over the 6 months following discharge. Primary outcomes were abstinence rates measured at 6 months and 1 year post-discharge. RESULTS: At follow-up, 43 and 34% of participants in minimal care and 67 and 55% of participants in intervention were abstinent at 6 and 12 months. respectively (P<0.05). Abstinence rates were calculated assuming that participants lost to attrition were smokers at follow-up. Intervention and self-efficacy were independent predictors of smoking status at follow-up. Low self-efficacy combined with no intervention resulted in a 93% relapse rate by 1 year (P<0.01). CONCLUSIONS: A hospital-based smoking cessation program consisting of inpatient counseling and telephone follow-up substantially increases smoking abstinence 1 year after discharge in patients post-MI. Patients with low self-efficacy are almost certain to relapse without intervention. Such smoking cessation programs should be part of the management of patients with MI.     

Modifications in postprandial triglyceride-rich lipoprotein composition and size after the intake of pomace olive oil

OBJECTIVE: This study was designed to determine the composition of postprandial triglyceride-rich lipoproteins (TRL) after the intake of pomace olive oil (POO), which is a subproduct of the extraction of virgin olive oil (VOO) and presents a high concentration of minor components with biological activity. METHODS: Meals enriched in POO and refined olive oil (ROO) were administrated to 9 healthy young men and blood was extracted every hour during a postprandial period of 7 hours. Serum and TRL lipid composition were measured by enzymatic and chromatographic methods and apolipoprotein B composition by SDS-PAGE. RESULTS: POO and ROO showed a very similar fatty acid composition but differed in their unsaponifiable fraction. The content of phytosterols, tocopherols, terpenic acids and alcohols and fatty alcohols was much higher in POO than in ROO. Serum lipids were not affected by the administration of the oils but the triglyceride concentration in TRL and the size of the particles (p < 0.05) after POO was higher at time point 2 h and lower at time point 4 h compared with ROO. In contrast, the number of TRL particles was lower after POO, although the rate of clearance was similar. CONCLUSION: We suggest that the unsaponifiable fraction between the two olive oils affect the size and composition of postprandial TRL, which might have a relevant impact on their atherogenicity.     

Fish oil intake compared with olive oil intake in late pregnancy and asthma in the offspring: 16 y of registry-based follow-up from a randomized controlled trial

BACKGROUND: Evidence suggests that asthma is rooted in the intrauterine environment and that intake of marine n-3 polyunsaturated fatty acids (n-3 PUFAs) in pregnancy may have immunomodulatory effects on the child. OBJECTIVE: Our aim was to examine whether increasing maternal intake of n-3 PUFAs in pregnancy may affect offspring risk of asthma. DESIGN: In 1990, a population-based sample of 533 women with normal pregnancies were randomly assigned 2:1:1 to receive four 1-g gelatin capsules/d with fish oil providing 2.7 g n-3 PUFAs (n = 266); four 1-g, similar-looking capsules/d with olive oil (n = 136); or no oil capsules (n = 131). Women were recruited and randomly assigned around gestation week 30 and asked to take capsules until delivery. Among 531 live-born children, 528 were identified in registries and 523 were still alive by August 2006. Diagnoses from the International Coding of Diseases version 10 were extracted from a mandatory registry that recorded diagnoses reported from hospital contacts. RESULTS: During the 16 y that passed since childbirth, 19 children from the fish oil and olive oil groups had received an asthma-related diagnosis; 10 had received the diagnosis allergic asthma. The hazard rate of asthma was reduced by 63% (95% CI: 8%, 85%; P = 0.03), whereas the hazard rate of allergic asthma was reduced by 87% (95% CI: 40%, 97%; P = 0.01) in the fish oil compared with the olive oil group. CONCLUSION: Under the assumption that intake of olive oil in the dose provided here was inert, our results support that increasing n-3 PUFAs in late pregnancy may carry an important prophylactic potential in relation to offspring asthma.     

Increases in plasma lycopene concentration after consumption of tomatoes cooked with olive oil

Lycopene is the main carotenoid in tomatoes and it has been hypothesised to be responsible for reducing the risk of some cancers and heart disease. The cooking of tomatoes with olive oil is a characteristic combination in the Southern Mediterranean diet. Previous studies have shown that the absorption of lycopene is greater from processed tomatoes than fresh tomatoes, since the processing breaks down the tomato cell matrix and makes the lycopene more available. The aim of the present study was to determine whether consumption of diced tomatoes cooked with olive oil resulted in higher plasma lycopene concentrations than consumption of diced tomatoes cooked without olive oil. Plasma lycopene concentrations were measured after 5 days on a low lycopene diet and again after a five-day dietary intervention, in healthy subjects, who consumed one meal per day of tomatoes (470 g) cooked with or without extra virgin olive oil (25 ml olive oil). There was an 82% increase in plasma trans-lycopene (P< 0.001) and a 40% in cis-lycopene (P = 0.002) concentrations in the 11 subjects who consumed tomatoes cooked in olive oil. There was no significant change in trans-lycopene (P = 0.684) and a 15% increase in cis-lycopene (P = 0.007) concentrations in 12 subjects consuming tomatoes cooked without olive oil. We conclude that the addition of olive oil to diced tomatoes during cooking greatly increases the absorption of lycopene. The results highlight the importance of cuisine (i.e how a food is prepared and consumed) in determining the bioavailability of dietary carotenoids such as lycopene.     

Moderate consumption of olive oil by healthy European men reduces systolic blood pressure in non-Mediterranean participants

We evaluated the effects of a moderate consumption of olive oil on lipid profile, BMI, and blood pressure (BP) in a group of 160 healthy men from non-Mediterranean regions [Northern Europe (n = 50; Finland and Denmark) and Central Europe (n = 60; Germany)] and Mediterranean regions [Southern Europe (n = 45; Italy and Spain)]. The study was a randomized, cross-over trial with 3 intervention periods of 3 wk and 2 wash-out periods of 2 wk. At the intervention periods, 3 similar olive oils (25 mL/d), differing only in their phenolic concentration, were administered to the healthy volunteers. Plasma oleic acid levels increased 2-3% (P < 0.05) in men from populations with lower habitual olive oil intakes (Northern and Central Europe). General linear models showed that the administration of the sequence of the 3 olive oils was responsible for a 3% decrease in systolic BP (SBP) (P < 0.05), but not in diastolic BP, in the non-Mediterranean subjects. Multivariate analysis indicated that the lipid profile did not change in either Mediterranean or non-Mediterranean men due to the olive oil intervention. The results of this study suggest that a moderate consumption of olive oil may be used as an effective tool to reduce SBP of healthy men who do not typically consume a Mediterranean diet. However, additional longer trials are necessary for confirmation.     

A randomized controlled trial of methylergonovine prophylaxis after dilation and evacuation abortion

ObjectiveTo evaluate the efficacy of intramuscular methylergonovine maleate as prophylaxis against excessive bleeding when given after dilation and evacuation (D&E) at 20–24 weeks.Study designWe performed a randomized, double-blinded, placebo-controlled trial in patients without excessive bleeding requiring intervention after D&E completion. We administered study treatment within one minute of the end of the procedure. We primarily compared outcomes using a composite of indicators of excessive post-procedure blood loss (post-procedure measured blood loss exceeding 125 mL, uterine massage or compression for at least two minutes, administration of additional uterotonic medication, intrauterine balloon tamponade, uterine re-aspiration, blood transfusion, uterine artery embolization, hospital admission for bleeding, or major surgery). Secondary outcomes included individual indicator occurrences, satisfaction, and side effects.ResultsFrom March 3, 2015 to March 31, 2017, we randomized 284 participants (n = 140 methylergonovine, n = 144 placebo), five before we registered the trial with clinicaltrials.gov. Baseline characteristics were similar between groups. The composite outcome occurred in 78 (56%) methylergonovine and 75 (52%) placebo participants (p = 0.5). Methylergonovine recipients required more intrauterine balloon use (n = 20 [14%]) versus placebo (n = 10 [7%]), p = 0.04. We also observed a non-significant trend towards more uterotonic administration (n = 56 [40%] versus n = 43 [30%], p = 0.07) and hospital admissions for bleeding (n = 4 [3%] versus n = 0, p = 0.06) in the methylergonovine group compared to placebo.ConclusionWe observed no improvement in the composite outcome for excessive bleeding with prophylactic post-procedure methylergonovine. In addition, individual excessive bleeding outcomes occurred more frequently in the methylergonovine group, potentially indicating harm with its prophylactic use after D&E.ImplicationsWhen administered prophylactically immediately after dilation and evacuation abortion at 20–24 weeks, methylergonovine increases uterine bleeding. Given the lack of data for effectiveness as a prophylactic agent and our findings indicating harm, we do not recommend its use for post-operative prophylaxis.     

A pilot,randomized controlled trial to examine the health outcomes of raisin consumption in patients with diabetes

ObjectivesDried fruits, like their fresh homologues, contain relatively high concentrations of antioxidants. The aim of this study was to determine the health outcomes of raisin consumption on patients with diabetes.MethodsWe examined the effects of dried grapes (Vitis vinifera) cultivated in Greece, namely Corinthian Raisins (CR) on blood pressure, fasting glucose, glucated hemoglobin (HbA_1c), lipid peroxidation, high-sensitivity C-reactive protein, antioxidant status, and cytokines in patients with type 2 diabetes mellitus (T2DM). Forty-eight well-controlled patients with T2DM from the diabetes outpatient clinic of our hospital were recruited to a two-armed, randomized, controlled, 24-wk prospective intervention trial in order to examine the health outcomes of CR consumption. All participants were reported to consume less fruits and vegetables than the recommended amount of five servings daily. Participants in the intervention were instructed to consume CR equal to two fruit servings (36 g/d), replacing snacks with similar energy density twice during the day. Anthropometric and blood pressure measurements, assessment of dietary intake, and fasting blood draws were conducted at baseline and at week 24. Also, phenolic compounds present in CR were analyzed in plasma of the patients. t Test for parametric data and Mann-Whitney test or Wilcoxon test for non-parametric data were performed. Significance was set at P < 0.05.ResultsBody weight, glycemic control, and lipid profile were not affected in either arm. Patients in the CR arm reduced their diastolic blood pressure and increased their total antioxidant potential significantly compared with baseline. The differences between the two groups at week 24 were significant. No change in high-sensitivity C-reactive protein was observed. A significant difference in plasma circulating p-hydroxybenzoic acid was observed between groups at the end of the trial.ConclusionsOur study shows that naturally CR may improve health features in patients with well-controlled T2DM.     

他莫昔芬联合小剂量睾酮治疗特发性少弱精子症的随机对照研究

目的评估他莫昔芬联合小剂量睾酮对特发性少弱精子症的治疗效果,并与单纯应用他莫昔芬的治疗效果进行比较。方法采用前瞻性随机对照研究,对2016年6月至2017年3月到邢台不孕不育专科医院就诊的特发性少弱精子症患者77例,采用分层随机分组的方法分为研究组和对照组,对用药前和用药3个月后精液分析中的精子浓度、前向运动精子百分率进行观察分析。结果研究组治疗前后精子浓度、前向运动精子百分率比较,差异均有统计学意义(P0.05);对照组治疗前后精子浓度差异有统计学意义(P0.05);两组治疗后,精子浓度比较差异有统计学意义(P0.05)。结论他莫昔芬联合小剂量睾酮治疗特发性少弱精子症,有助于改善精子浓度,效果优于单一使用他莫昔芬。