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The effects of l-Carnitine supplementation on inflammatory markers, clinical status, and 28 days mortality in critically ill patients: A double-blind, randomized, placebo-controlled trial.
Yahyapoor, F, Sedaghat, A, Feizi, A, Bagherniya, M, Pahlavani, N, Khadem-Rezaiyan, M, Safarian, M, Islam, MS, Zarifi, SH, Arabi, SM, et al
Clinical nutrition ESPEN. 2022;:61-67
Abstract
AIM: Critical ill patients experience catabolic stress, which results in a systemic inflammatory response. The inflammatory response is associated with increased complications, including infection, multi-organ dysfunction, increased length of ICU stays, and mortality. l-Carnitine supplementation may play an important role in these patients by regulating inflammatory cell function. The purpose of the present study was to investigate the effect of l-Carnitine supplementation on clinical status, inflammatory markers, and mortality rate in critically ill patients admitted to the intensive care unit (ICU). METHODS This randomized, double-blind, placebo-controlled trial was performed on critically ill patients. Subjects were randomly assigned into placebo (n = 27) and l-Carnitine (n = 27) groups. l-Carnitine (3000 mg/day) was administered via nasogastric tube for the intervention group for 7 days, while the other group received a placebo for the same duration. Serum levels of inflammatory markers, including C-reactive protein (CRP) and interleukin-6 (IL-6) were measured. Nutritional status and the acute physiology and chronic health evaluation (APACHE) score, sequential organ failure assessment (SOFA) score, and 28-day mortality were also recorded. RESULTS Fifty-one critically ill patients completed the study. l-Carnitine supplementation significantly reduced the levels of CRP (mean change ± SE: -34.9 ± 6.5) and IL-6 (mean change ± SE: -10.64 ± 2.16) compared to the baseline, which is both statistically significant compared with the control group (p < 0.05). The SOFA and APACHE scores were significantly reduced in the l-Carnitine group compared with the placebo group (p = 0.02 and p < 0.001, respectively). CONCLUSIONS l-Carnitine supplementation showed beneficial effects on inflammatory and clinical outcomes of critically ill patients. TRIAL REGISTRATION DETAILS Trial registration: IRCT, Registered 30 May 2018, https://www.irct.ir/trial/30748.
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Effects of Melatonin and Propolis Supplementation on Inflammation, Oxidative Stress, and Clinical Outcomes in Patients with Primary Pneumosepsis: A Randomized Controlled Clinical Trial.
Pahlavani, N, Malekahmadi, M, Sedaghat, A, Rostami, A, Alkadir, OKA, Taifi, A, Ranjbar, G, Sahebkar, A, Abdelbasset, WK, Beigmohammadi, MT, et al
Complementary medicine research. 2022;(4):275-285
Abstract
BACKGROUND AND OBJECTIVE The present study aimed to investigate the effects of propolis and melatonin supplementation on inflammation, clinical outcomes, and oxidative stress markers in patients with primary pneumosepsis. MATERIALS AND METHODS This pilot randomized controlled trial was conducted on 55 patients with primary pneumosepsis who were randomly assigned to the intervention and control groups. In the three intervention groups, the patients received propolis alone (1,000 mg/day), propolis (1,000 mg/day) plus melatonin (20 mg/day), and melatonin alone (20 mg/day). The control group received placebo. The inflammatory and oxidative stress markers as well as clinical outcomes were evaluated before and after the intervention, and the 28-day survival rate was also recorded. RESULTS After the intervention, the combination of propolis and melatonin significantly reduced interleukin-6 (-55.282 pg/mL) and C-reactive protein (-21.656 mg/L) levels, while increasing gavage intake (326.680 mL/day) and improving some clinical outcomes (APACHE II, SOFA, and NUTRIC scores) compared to the control group. However, no significant difference was observed between the groups in terms of oxidative stress and hematological indices. In addition, there was no significant difference in the 28-day survival rate between the groups (p = 0.07). CONCLUSION Supplementation with propolis and melatonin may improve clinical outcomes by reducing inflammation. Further investigations are required to confirm these findings.
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The effect of vitamin D and magnesium supplementation on the mental health status of attention-deficit hyperactive children: a randomized controlled trial.
Hemamy, M, Pahlavani, N, Amanollahi, A, Islam, SMS, McVicar, J, Askari, G, Malekahmadi, M
BMC pediatrics. 2021;21(1):178
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Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder and studies have found it to be associated with nutrient deficiencies, namely magnesium and vitamin D. The aim of this randomized, controlled study is to assess the effect of vitamin D and magnesium supplementation on mental health and behavioral outcomes in children with ADHD. Sixty-six children with ADHD were randomly allocated to receive both vitamin D plus magnesium or placebo for eight weeks, and a validated children’s mental health questionnaire was assessed. After eight weeks, serum vitamin D and magnesium, as well as various behavioural outcomes (emotional problem, peer problem, total difficulties and internalising), were all significantly improved among the treatment group compared to placebo. Based on these results, the authors conclude co-supplementing vitamin D and magnesium can improve the behavioral function and mental health of children with ADHD. They suggest larger, well-designed studies are needed to both validate these findings and further explore whether micronutrient deficiencies in ADHD are a cause or effect of the disorder.
Abstract
BACKGROUND Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in people with ADHD. The aim of this study is to determine the effect of vitamin D and magnesium supplementation on mental health in children with ADHD. METHODS We conducted a randomized, double blind, placebo-controlled clinical trial of 66 children with ADHD. Participants were randomly allocated to receive both vitamin D (50,000 IU/week) plus magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8-weeks. Strengths and difficulties questionnaire was used to evaluate children's mental health at baseline and the end of the study. RESULTS After eight weeks of intervention, the serum levels of 25-hydroxy-vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also, children receiving vitamin D plus magnesium showed a significant reduction in emotional problems (p = 0.001), conduct problems (p = 0.002), peer problems (p = 0.001), prosocial score (p = 0.007), total difficulties (p = 0.001), externalizing score (p = 0.001), and internalizing score (p = 0.001) compared with children treated with the placebo. CONCLUSION Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation for a duration of 8-weeks could improve the behavioral function and mental health of children with ADHD. However, further well-designed studies with a larger sample size are needed. TRIAL REGISTRATION IRCT2016030326886N1 .
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The effect of French maritime pine bark extract supplementation on inflammation, nutritional and clinical status in critically ill patients with traumatic brain injury: A randomized controlled trial.
Malekahmadi, M, Shadnoush, M, Islam, SMS, Shirvani, A, Pahlavani, N, Gholizadeh Navashenaq, J, Firouzi, S, McVicar, J, Nematy, M, Zali, MR, et al
Phytotherapy research : PTR. 2021;(9):5178-5188
Abstract
Inflammation plays an important role in the pathophysiology of traumatic brain injury (TBI). Based on the anti-inflammatory properties of French maritime pine bark extract and the neuroprotective effects, we aimed to evaluate the effects of its supplementation on TBI. Sixty-seven TBI patients admitted to the intensive care units (ICUs) were enrolled. After stabilizing the hemodynamic status, the intervention group received 150 mg of French maritime pine bark extract supplementation (Oligopin) with enteral nutrition for 10 days. The control group received a placebo. Inflammatory status and oxidative stress markers were measured three times. Also, clinical and nutritional statuses were assessed. Supplementation, significantly decreased IL-6 (β = -53.43 pg/ml, 95% confidence interval [CI] = -91.74, -15.13, p = .006), IL-1β (β = -111.66 pg/ml, 95% CI = -183.79, -39.5402, p = .002) and C-reactive protein (β = -19.99 mg/L, 95% CI = -27.23, -12.76, p ˃ .001) in the intervention group compared to control group after 10 days. Clinical scores including acute physiology and chronic health evaluation II and sequential organ failure assessment were reduced (β = -3.72, 95% CI = -5.96, -1.49, p = .001and β = -2.07, 95% CI = -3.23, -0.90, p < .001, respectively), and Nutric score was reduced compared to control group (β = -.60, 95% CI = -1.08, -0.12, p = .01). The survival rate was higher by 15% in the intervention group compared to control group. Oligopin supplementation in TBI patients in ICU reduced inflammation and improved the clinical status and malnutrition score and thereby reducing the mortality rate.
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Effects of propolis and melatonin on oxidative stress, inflammation, and clinical status in patients with primary sepsis: Study protocol and review on previous studies.
Pahlavani, N, Sedaghat, A, Bagheri Moghaddam, A, Mazloumi Kiapey, SS, Gholizadeh Navashenaq, J, Jarahi, L, Reazvani, R, Norouzy, A, Nematy, M, Safarian, M, et al
Clinical nutrition ESPEN. 2019;:125-131
Abstract
BACKGROUND Previous studies have explored the anti-inflammatory, anti-infection and oxidative stress reduction effects of propolis and melatonin in experimental studies. However, there are no studies at present exploring the effects of propolis and melatonin in patients with primary sepsis. The present study aims to evaluate the potential effects of propolis and melatonin as a pharmaceutical agent in patients with primary sepsis. METHODS/DESIGN The study will be conducted as a randomized controlled clinical trial at the Imamreza hospital. Patients with primary sepsis, in four equal groups, will be recruited for the study. The treatment drugs are propolis and melatonin and the placebo. The following primary and secondary outcome measures will be evaluated: APACHE II Score, SOFA score, NUTRIC score, inflammatory factors, and oxidative stress markers. DISCUSSION We describe the protocol for a clinical trial design evaluating the effects of simultaneous administration of propolis and melatonin in patients with primary sepsis. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of propolis and melatonin as an auxiliary treatment in patients with primary sepsis. TRIAL REGISTRATION Iranian Registry of Clinical Trials: IRCT20181025041460N1. Registered on 6 November 2018.
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The effect of honey consumption compared with sucrose on lipid profile in young healthy subjects (randomized clinical trial).
Rasad, H, Entezari, MH, Ghadiri, E, Mahaki, B, Pahlavani, N
Clinical nutrition ESPEN. 2018;:8-12
Abstract
BACKGROUND AND AIMS Several studies have demonstrated that honey consumption has beneficial effects on cardiovascular disease indicators. The current study aimed to investigate the effect of honey consumption compared with sucrose on lipid profile among young healthy subjects. METHODS Sixty healthy subjects, aged 18-30 years, were randomly recruited into this double blind randomized trial and assigned into two groups: honey (received 70 g honey per day) and sucrose (received 70 g sucrose per day) groups. Total cholesterol, TG, LDL and HDL were measured in the control and intervention groups at the beginning and end of study. RESULTS In this trial, the baseline FBS, SBP and DBP were not different between honey and sucrose groups (P > 0.3). We found evidence indicating consumption of honey can decrease total cholesterol, TG and LDL and increase HDL in healthy young subjects, but intake of sucrose increase total cholesterol, TG and LDL and decreased HDL. In all of these analyses, confounding variable including age, physical activity and some nutrient intake were adjusted. CONCLUSIONS Honey consumption can improve the lipid profile such as; total cholesterol, TG and LDL and increase HDL, but consumption of sucrose increases total cholesterol, TG and LDL and decreases HDL. Further clinical trial studies are required to confirm our findings.
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The effect of l-arginine supplementation on body composition and performance in male athletes: a double-blinded randomized clinical trial.
Pahlavani, N, Entezari, MH, Nasiri, M, Miri, A, Rezaie, M, Bagheri-Bidakhavidi, M, Sadeghi, O
European journal of clinical nutrition. 2017;(4):544-548
Abstract
BACKGROUND/OBJECTIVE Athletes used a lot of dietary supplements to achieve the more muscle mass and improve their athletic performance. The objective of this study was to investigate the effect of l-arginine supplementation on sport performance and body composition in male soccer players. SUBJECTS/METHODS This double-blinded, randomized and placebo-controlled trial was conducted on 56 male soccer players, with age range of 16-35, who referred to sport clubs in Isfahan, Iran. Subjects were randomly assigned to either l-arginine or placebo groups. Athletes received daily either 2 g per day l-arginine supplement or the same amount of placebo (maltodextrin) for 45 days. Sport performance and also body mass index (BMI), body fat mass (BFM) and lean body mass (LBM) were measured at the beginning and end of the study. Also, 3-day dietary records were collected at three different time points (before, in the middle of, and at the end of the study). RESULTS The mean age of subjects was 20.85±4.29 years. Sport performance (VO2 max) significantly increased in l-arginine supplementation group (4.12±6.07) compared with placebo group (1.23±3.36) (P=0.03). This increase remained significant even after adjustment of baseline values, physical activity and usual dietary intake of subjects throughout the study. No significant effect of l-arginine supplementation was found on weight, BMI, BFM and LBM. CONCLUSIONS l-arginine supplementation (2 g per day) could increase the sport performance in male athletes, but had no effect on anthropometric measurements, including BMI, BFM and LBM. So, further studies are needed to shed light our findings.