Elevated Serum Inflammatory Markers in Subacute Stroke Are Associated With Clinical Outcome but Not Modified by Aerobic Fitness Training: Results of the Randomized Controlled PHYS-STROKE Trial

Background: Inflammatory markers, such as C-reactive Protein (CRP), Interleukin-6 (IL-6), tumor necrosis factor (TNF)-alpha and fibrinogen, are upregulated following acute stroke. Studies have shown associations of these biomarkers with increased mortality, recurrent vascular risk, and poor functional outcome. It is suggested that physical fitness training may play a role in decreasing long-term inflammatory activity and supports tissue recovery.Aim: We investigated the dynamics of selected inflammatory markers in the subacute phase following stroke and determined if fluctuations are associated with functional recovery up to 6 months. Further, we examined whether exposure to aerobic physical fitness training in the subacute phase influenced serum inflammatory markers over time.Methods: This is an exploratory analysis of patients enrolled in the multicenter randomized-controlled PHYS-STROKE trial. Patients within 45 days of stroke onset were randomized to receive either four weeks of aerobic physical fitness training or relaxation sessions. Generalized estimating equation models were used to investigate the dynamics of inflammatory markers and the associations of exposure to fitness training with serum inflammatory markers over time. Multiple logistic regression models were used to explore associations between inflammatory marker levels at baseline and three months after stroke and outcome at 3- or 6-months.Results: Irrespective of the intervention group, high sensitive CRP (hs-CRP), IL-6, and fibrinogen (but not TNF-alpha) were significantly lower at follow-up visits when compared to baseline (p all ≤ 0.01). In our cohort, exposure to aerobic physical fitness training did not influence levels of inflammatory markers over time. In multivariate logistic regression analyses, increased baseline IL-6 and fibrinogen levels were inversely associated with worse outcome at 3 and 6 months. Increased levels of hs-CRP at 3 months after stroke were associated with impaired outcome at 6 months. We found no independent associations of TNF-alpha levels with investigated outcome parameters.Conclusion: Serum markers of inflammation were elevated after stroke and decreased within 6 months. In our cohort, exposure to aerobic physical fitness training did not modify the dynamics of inflammatory markers over time. Elevated IL-6 and fibrinogen levels in early subacute stroke were associated with worse outcome up to 6-months after stroke.Clinical Trial Registration:ClinicalTrials.gov, NCT01953549.

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Baseline high-sensitivity C-reactive protein to predict progression-free survival in metastatic renal cell carcinoma patients treated with first-line sunitinib.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e15527 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e15527-e15527

Author(s):

Ryuichi Mizuno ◽

Go Kimura ◽

Tsunenori Kondo ◽

Takeshi Ueda ◽

Hidehiko Hara ◽

...

Keyword(s):

Interleukin 6 ◽

Inflammatory Markers ◽

Progression Free Survival ◽

High Sensitivity ◽

C Reactive Protein ◽

First Line ◽

Free Survival ◽

Reactive Protein ◽

Hs Crp ◽

Serum Inflammatory Markers

e15527 Background: Predicting the efficacy of tyrosine kinase inhibitors (TKI) would be of clinical value in patients with metastatic renal cell carcinoma (mRCC). We tested the hypothesis that serum inflammatory markers are associated with clinical outcome in mRCC patients at favorable or intermediate prognostic risk treated with first-line sunitinib. Methods: Eighty-nine mRCC patients were prospectively monitored at baseline (day 0) during sunitinib treatment. Serum interleukin-6 and 8 levels were determined by CLEIA and ELISA, respectively. A high-sensitivity C-reactive protein (hs-CRP) levels were measured using laser nephelometry. Correlations between baseline interleukin-6, 8, hs-CRP levels and response to sunitinib, and progression-free survival (PFS) were examined. Results: Median PFS was 9.2 months. Clinical benefit rate (CBR; percent complete responses+partial responses +stable disease 24 weeks) was 57.3%. Baseline interleukin-8 (P=0.0240) and hs-CRP (P=0.0060) was associated with CBR. No association between baseline interleukin-6 and 8 with PFS was observed. However, baseline hs-CRP were associated with PFS (P=0.0016; unit risk 1.010; 95% CI 1.004 to 1.017). Conclusions: Baseline serum inflammatory markers could be of clinical interest in sunitinib-treated mRCC patiens to predict outcome. Baseline hs-CRP serum levels warrant further study. Clinical trial information: UMIN000009622.

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Effects of Astragalus injection and Salvia Miltiorrhiza injection on serum inflammatory markers in patients with stable coronary heart disease: a randomized controlled trial protocol

Trials ◽

10.1186/s13063-020-4109-6 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 1

Author(s):

Zhihao Luo ◽

Yuntao Liu ◽

Zhen Zhao ◽

Xia Yan ◽

Dawei Wang ◽

...

Keyword(s):

Coronary Heart Disease ◽

Randomized Controlled Trial ◽

Heart Disease ◽

Inflammatory Markers ◽

Salvia Miltiorrhiza ◽

Controlled Trial ◽

Trial Protocol ◽

Randomized Controlled ◽

Stable Coronary Heart Disease ◽

Serum Inflammatory Markers

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Effect of Anthocyanin Supplementations on Lipid Profile and Inflammatory Markers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Cholesterol ◽

10.1155/2018/8450793 ◽

2018 ◽

Vol 2018 ◽

pp. 1-12 ◽

Cited By ~ 10

Author(s):

Komal Shah ◽

Pratik Shah

Keyword(s):

Randomized Controlled Trials ◽

Lipid Profile ◽

Inflammatory Markers ◽

Meta Analysis ◽

Density Lipoprotein ◽

Mean Difference ◽

Controlled Trials ◽

Randomized Controlled ◽

Inflammatory Status ◽

Hs Crp

Purpose. To assess combined data from seventeen randomized controlled trials studying effect of anthocyanin consumption on levels of various lipids and inflammatory markers with meta-analysis approach. Methods. Various databases, namely, PubMed, MEDLINE, EMBASE, and Cochrane Trial Register were used to identify randomized controlled trials (RCTs) investigating an association between anthocyanins and lipid profile and inflammatory markers. Heterogeneity was assessed using Q and I2 statistics and data was expressed using mean difference with 95% confidence interval. Results. Statistically significant reduction in triglyceride [mean difference (MD) = −9.16, 95% CI: −14.02 to −4.31 mg/dL, I2=33.54%, P=0.149], low density lipoprotein [MD = −8.86, 95% CI: −11.17 to −20.02 mg/dL, I2 = 37.75%, P=0.098], and apolipoprotein B [MD = −7.13, 95% CI: −8.66 to −5.59 mg/dL, I2=20.42%, P=0.287] levels and increase in high-density lipoprotein [MD = 1.67, 95% CI: 0.8 to 2.54 mg/dL, I2=44.88%, P=0.053] and apolipoprotein A-1 [MD = 6.1, 95% CI: 4.51 to 7.69 mg/dL, I2=6.95%, P=0.358] levels were observed with anthocyanin supplementation. Levels of inflammatory markers were found to reduce [TNF-∞ - MD = −1.98, 95% CI: −2.40 to −1.55 pg/mL, I2=0%, P=0.975; IL-6 - MD = 1.17, 95% CI: 0.8 to 1.53 pg/mL, I2=0%, P=0.825; hs-CRP - MD = 0.164, 95% CI: −0.06 to 0.39 mg/dL, I2=0%, P=0.569]. Though the effect on TC, IL-6, and hs-CRP was positive, it was nonsignificant in nature. Conclusion. Anthocyanin supplementation significantly improves lipid profile and inflammatory status. However, future trials with sufficient sample size are recommended to substantiate the findings especially for the parameters showing nonsignificant improvement.

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Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): multicentre, randomised controlled, endpoint blinded trial

BMJ ◽

10.1136/bmj.l5101 ◽

2019 ◽

pp. l5101 ◽

Cited By ~ 7

Author(s):

Alexander H Nave ◽

Torsten Rackoll ◽

Ulrike Grittner ◽

Holger Bläsing ◽

Anna Gorsler ◽

...

Keyword(s):

Confidence Interval ◽

Physical Fitness ◽

Barthel Index ◽

Daily Living ◽

Walking Speed ◽

Barthel Index Score ◽

Subacute Stroke ◽

Fitness Training ◽

Randomised Controlled ◽

Blinded Trial

AbstractObjectiveTo determine the safety and efficacy of aerobic exercise on activities of daily living in the subacute phase after stroke.DesignMulticentre, randomised controlled, endpoint blinded trial.SettingSeven inpatient rehabilitation sites in Germany (2013-17).Participants200 adults with subacute stroke (days 5-45 after stroke) with a median National Institutes of Health stroke scale (NIHSS, range 0-42 points, higher values indicating more severe strokes) score of 8 (interquartile range 5-12) were randomly assigned (1:1) to aerobic physical fitness training (n=105) or relaxation sessions (n=95, control group) in addition to standard care.InterventionParticipants received either aerobic, bodyweight supported, treadmill based physical fitness training or relaxation sessions, each for 25 minutes, five times weekly for four weeks, in addition to standard rehabilitation therapy. Investigators and endpoint assessors were masked to treatment assignment.Main outcome measuresThe primary outcomes were change in maximal walking speed (m/s) in the 10 m walking test and change in Barthel index scores (range 0-100 points, higher scores indicating less disability) three months after stroke compared with baseline. Safety outcomes were recurrent cardiovascular events, including stroke, hospital readmissions, and death within three months after stroke. Efficacy was tested with analysis of covariance for each primary outcome in the full analysis set. Multiple imputation was used to account for missing values.ResultsCompared with relaxation, aerobic physical fitness training did not result in a significantly higher mean change in maximal walking speed (adjusted treatment effect 0.1 m/s (95% confidence interval 0.0 to 0.2 m/s), P=0.23) or mean change in Barthel index score (0 (−5 to 5), P=0.99) at three months after stroke. A higher rate of serious adverse events was observed in the aerobic group compared with relaxation group (incidence rate ratio 1.81, 95% confidence interval 0.97 to 3.36).ConclusionsAmong moderately to severely affected adults with subacute stroke, aerobic bodyweight supported, treadmill based physical fitness training was not superior to relaxation sessions for maximal walking speed and Barthel index score but did suggest higher rates of adverse events. These results do not appear to support the use of aerobic bodyweight supported fitness training in people with subacute stroke to improve activities of daily living or maximal walking speed and should be considered in future guidelines.Trial registrationClinicalTrials.gov NCT01953549.

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Effects of garlic supplementation on serum inflammatory markers: A systematic review and meta-analysis of randomized controlled trials

Diabetes & Metabolic Syndrome Clinical Research & Reviews ◽

10.1016/j.dsx.2020.06.031 ◽

2020 ◽

Vol 14 (5) ◽

pp. 1153-1161

Author(s):

Farhang Mirzavandi ◽

Mehdi Mollahosseini ◽

Amin Salehi-Abargouei ◽

Elham makiabadi ◽

Hassan Mozaffari-Khosravi

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Inflammatory Markers ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled ◽

Serum Inflammatory Markers

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The Effect of Sodium Tanshinone IIA Sulfate and Simvastatin on Elevated Serum Levels of Inflammatory Markers in Patients with Coronary Heart Disease: A Study Protocol for a Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/756519 ◽

2013 ◽

Vol 2013 ◽

pp. 1-8 ◽

Cited By ~ 13

Author(s):

Qinghua Shang ◽

Hanjay Wang ◽

Siming Li ◽

Hao Xu

Keyword(s):

Inflammatory Markers ◽

Controlled Trial ◽

Blood Stasis ◽

Elevated Serum ◽

Tanshinone Iia ◽

Blood Stasis Syndrome ◽

Randomized Controlled ◽

Hs Crp ◽

Experimental Group ◽

Circulating Inflammatory Markers

Background. Coronary heart disease (CHD) due to atherosclerotic inflammation remains a significant threat to global health despite the success of the lipid-lowering, anti-inflammatory statins. Tanshinone IIA, a potent anti-inflammatory compound derived from Traditional Chinese Medicine (TCM), may be able to supplement statins by further reducing levels of circulating inflammatory markers correlated to cardiovascular risk. Here, we present the protocol of a randomized controlled trial (RCT) that will investigate the synergistic effect of sodium tanshinone IIA sulfate and simvastatin on reducing elevated inflammatory markers in patients with CHD. Participants: Seventy-two inpatients with confirmed CHD, elevated serum high-sensitivity C-reactive protein (Hs-CRP) level, and a TCM diagnosis of blood stasis syndrome will be enrolled and randomized 1 : 1 into the control or experimental group.Intervention. All subjects will receive a standard Western therapy including 20 mg simvastatin orally once per evening. Patients in the experimental group will additionally receive a daily 80 mg dose of sodium tanshinone IIA sulfate intravenously, diluted into 250 mL 0.9% NaCl solution. The treatment period will be 14 days.Outcomes. Primary outcome parameter: serum Hs-CRP level. Secondary outcome parameters: other circulating inflammatory markers (including IL-6, TNFα, VCAM-1, CD40, sCD40L, MCP-1, and MMP-9), improvement in symptoms of angina and blood stasis syndrome, and safety. This trial is registered withChiCTR-TRC-12002361.

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Television During Meals in the First 4 Years of Life

Clinical Pediatrics ◽

10.1177/0009922816678585 ◽

2016 ◽

Vol 56 (7) ◽

pp. 659-666 ◽

Cited By ~ 5

Author(s):

Lindsay M. Thimmig ◽

Michael D. Cabana ◽

Michael G. Bentz ◽

Katherine Potocka ◽

Amy Beck ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Early Childhood ◽

Logistic Regression ◽

Controlled Trial ◽

Family Characteristics ◽

Annual Income ◽

Randomized Controlled ◽

Multivariable Logistic Regression ◽

College Educated ◽

Over Time

The development of children’s mealtime television (TV) habits has not been well studied. We assessed whether mealtime TV habits established in infancy will persist into early childhood. We analyzed data collected through parent surveys at birth and at 6-month intervals from a randomized controlled trial. We used t-tests, χ2 tests, and a multivariable logistic regression to determine if family characteristics were associated with mealtime TV. A McNemar test was used to assess whether mealtime TV exposure changed over time. College-educated fathers and families with an annual income >$50 000 were associated with less-frequent TV exposure during children’s mealtimes. It was found that 84% of children retained their level of exposure to TV during mealtimes from the first 24 months through 48 months of life. Clinicians should counsel families about mealtime TV use within the first 2 years of life because these habits seem to develop early and persist into at least early childhood.

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No effect of fish oil supplementation on serum inflammatory markers and their interrelationships: a randomized controlled trial in healthy, middle-aged individuals

European Journal of Clinical Nutrition ◽

10.1038/ejcn.2009.63 ◽

2009 ◽

Vol 63 (11) ◽

pp. 1353-1359 ◽

Cited By ~ 47

Author(s):

G K Pot ◽

I A Brouwer ◽

A Enneman ◽

G T Rijkers ◽

E Kampman ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Fish Oil ◽

Inflammatory Markers ◽

Controlled Trial ◽

Middle Aged ◽

Randomized Controlled ◽

Fish Oil Supplementation ◽

Serum Inflammatory Markers

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Thirty Days of Montmorency Tart Cherry Supplementation Has No Effect on Gut Microbiome Composition, Inflammation, or Glycemic Control in Healthy Adults

Frontiers in Nutrition ◽

10.3389/fnut.2021.733057 ◽

2021 ◽

Vol 8 ◽

Author(s):

Angela R. Hillman ◽

Bryna C. R. Chrismas

Keyword(s):

Glycemic Control ◽

Gut Microbiome ◽

Inflammatory Markers ◽

Glycated Albumin ◽

Tnf Alpha ◽

Tart Cherry ◽

Freeze Dried ◽

Significant Change ◽

Tart Cherries ◽

Over Time

Tart cherries possess properties that may reduce inflammation and improve glycemic control, however human data on supplementation and the gut microbiota is equivocal. Processing (i.e., juice concentrate, dried, frozen) may affect the properties of tart cherries, and therefore alter their efficacious health benefits. Therefore, the purpose of this study was to investigate the effect of 30 days of supplementation with Montmorency tart cherry (MTC) in concentrate or freeze-dried form on the gut microbiome and markers of inflammation and glycemic control. Healthy participants with no known disease (n = 58, age: 28 ± 10 y, height: 169.76 ± 8.55 cm, body mass: 72.2 ± 12.9 kg) were randomly allocated to four groups and consumed either concentrate or freeze-dried capsules or their corresponding placebos for 30 days. Venous blood samples were drawn at baseline, day 7, 14, and 30 and analyzed for inflammatory markers TNF-alpha, uric acid, C-reactive protein, and erythrocyte sedimentation rate and glycemic control markers glycated albumin, glucose and insulin. A fecal sample was provided at baseline, day 14 and 30 for microbiome analysis. TNF-alpha was significantly lower at 30 vs. 14 days (p = 0.01), however there was no other significant change in the inflammatory markers. Insulin was not changed over time (p = 0.16) or between groups (p = 0.24), nor was glycated albumin different over time (p = 0.08) or between groups (p = 0.56), however glucose levels increased (p < 0.001) from baseline (4.79 ± 1.00 mmol·L−1) to 14 days (5.21 ± 1.02 mmol·L−1) and 30 days (5.61 ± 1.22 mmol·L−1) but this was no different between groups (p = 0.33). There was no significant change in composition of bacterial phyla, families, or subfamilies for the duration of this study nor was there a change in species richness. These data suggest that 30 days of MTC supplementation does not modulate the gut microbiome, inflammation, or improve glycemic control in a healthy, diverse group of adults.Clinical Trail Registration:https://clinicaltrials.gov/ct2/show/NCT04467372, identifier: NCT04467372.

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