-
1.
The effects of L-carnitine supplementation on inflammation, oxidative stress, and clinical outcomes in critically Ill patients with sepsis: a randomized, double-blind, controlled trial.
Keshani, M, Alikiaii, B, Babaei, Z, Askari, G, Heidari, Z, Sharma, M, Bagherniya, M
Nutrition journal. 2024;(1):31
Abstract
BACKGROUND Sepsis, a life-threatening organ dysfunction caused by a host's dysregulated response to infection with an inflammatory process, becomes a real challenge for the healthcare systems. L-carnitine (LC) has antioxidant and anti-inflammatory properties as in previous studies. Thus, we aimed to determine the effects of LC on inflammation, oxidative stress, and clinical parameters in critically ill septic patients. METHODS A randomized double-blinded controlled trial was conducted. A total of 60 patients were randomized to receive LC (3 g/day, n = 30) or placebo (n = 30) for 7 days. Inflammatory and oxidative stress parameters (C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), superoxide dismutase (SOD), malondialdehyde (MDA), total antioxidant capacity (TAC), 28-day mortality rate, and some monitoring variables were evaluated. RESULTS There was no statistically significant difference between study arms in baseline characteristics and disease severity scores. CRP (p < 0.001) and ESR (p: 0.004) significantly reduced, and SOD (p < 0.001) and TAC (p < 0.001) significantly improved in the LC group after 7 days. Between-group analysis revealed a significant reduction in CRP (p: 0.001) and serum chloride (p: 0.032), an increase in serum albumin (p: 0.036) and platelet (p: 0.004) significantly, and an increase in SOD marginally (p: 0.073). The 28-day mortality rate was also lower in the LC group compared with placebo (7 persons vs. 15 persons) significantly (odds ratio: 0.233, p: 0.010). CONCLUSIONS L-carnitine ameliorated inflammation, enhanced antioxidant defense, reduced mortality, and improved some clinical outcomes in critically ill patients with sepsis. TRIAL REGISTRATION IRCT20201129049534N1; May 2021.
-
2.
Coenzyme Q10 supplementation in burn patients: a double-blind placebo-controlled randomized clinical trial.
Kiani, Z, Khorsand, N, Beigi, F, Askari, G, Sharma, M, Bagherniya, M
Trials. 2024;(1):160
Abstract
BACKGROUND Burn injuries are important medical problems that, aside from skin damage, cause a systemic response including inflammation, oxidative stress, endocrine disorders, immune response, and hypermetabolic and catabolic responses which affect all the organs in the body. The aim of this study was to determine the effect of coenzyme Q10 (CoQ10) supplementation on inflammation, oxidative stress, and clinical outcomes in burn patients. METHODS In a double-blind placebo-controlled randomized clinical trial, 60 burn patients were randomly assigned to receive 100 mg CoQ10 three times a day (total 300 mg/day) or a placebo for 10 days. Inflammatory markers including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), oxidative stress markers including total antioxidant capacity (TAC), malondialdehyde (MDA) and superoxide dismutase (SOD) activity, fasting blood glucose (FBG), blood urea nitrogen (BUN), creatinine, white blood cells (WBC), and body temperature were assessed as primary outcomes and albumin, prothrombin time (PT), partial thromboplastin time (PTT), international normalized ratio (INR), other hematological parameters, blood pressure, O2 saturation, ICU duration, and 28-mortality rate were assessed as secondary outcomes. RESULTS Fifty-two participants completed the trial. CRP and ESR levels were not significantly different between CoQ10 and placebo groups at the end of the study (P = 0.550 and P = 0.306, respectively). No significant differences between groups were observed for TAC (P = 0.865), MDA (P = 0.692), and SOD activity (P = 0.633) as well. Administration of CoQ10 resulted in a significant increase in albumin levels compared to placebo (P = 0.031). There was no statistically significant difference between the two groups in other measured outcomes (P > 0.05). CONCLUSION Results showed that in patients with burn injury, CoQ10 administration had no effect on inflammatory markers and oxidative stress, although serum albumin levels were improved after supplementation. Further studies with albumin as the primary outcome are needed to confirm this finding.
-
3.
Effect of propolis on mood, quality of life, and metabolic profiles in subjects with metabolic syndrome: a randomized clinical trial.
Sajjadi, SS, Bagherniya, M, Soleimani, D, Siavash, M, Askari, G
Scientific reports. 2023;(1):4452
Abstract
Metabolic syndrome (MeS) is a common multifaceted disorder. Plants contain antioxidant bioactive compounds, which are beneficial to improve the health condition of patients with MeS. Propolis is a hive natural product that is composed of various constituent. We aimed to assess the effects of Iranian propolis as a natural and safe agent on indicators of MeS, quality of life and mood status in individuals with MeS. In total, 66 interested eligible patients recruited to the present study. Participants were randomly assigned to consume a tablet at dose of 250 mg of propolis extract, twice daily for 12 weeks or placebo. Propolis supplementation could lead to a significant reduction in waist circumference (WC), increase in physical functioning, general health and the overall score of SF-36 compared with placebo group (P-value < 0.05). However, no significant differences were observed regarding other anthropometric indices and biochemical parameters between two groups (P-value > 0.05). The current study indicated that propolis can be effective in decreasing WC and improving physical health and quality of life, while had no significant effects on other components of MeS among subjects with this syndrome. Clinical trials registration Iran Registry of Clinical Trials.ir IRCT20121216011763N49, registration date 23/12/2020.
-
4.
The effects of curcumin-piperine supplementation on inflammatory, oxidative stress and metabolic indices in patients with ischemic stroke in the rehabilitation phase: a randomized controlled trial.
Boshagh, K, Khorvash, F, Sahebkar, A, Majeed, M, Bahreini, N, Askari, G, Bagherniya, M
Nutrition journal. 2023;(1):69
Abstract
BACKGROUND Stroke is a leading cause of death worldwide, which is associated with a heavy economic and social burden. The purpose of this study was to investigate the effects of supplementation with curcumin-piperine combination in patients with ischemic stroke in the rehabilitation stage. METHODS In this randomized controlled trial, 66 patients with stroke were randomized into two groups receiving curcumin-piperine tablets (500 mg curcumin + 5 mg piperine) and matched placebo tablets for 12 weeks. High-sensitivity C-reactive protein (hs-CRP), carotid intima-media thickness (CIMT), thrombosis, total antioxidant capacity (TAC), lipid profile, anthropometric indices, blood pressure, and quality of life were assessed before and after the intervention. Statistical data analysis was done using SPSS22 software. RESULTS A total of 56 patients with a mean age of 59.80 ± 4.25 years completed the trial. Based on ANCOVA test, adjusted for baseline values, curcumin-piperine supplementation for 12 weeks resulted in significant reductions in serum levels of hs-CRP (p = 0.026), total cholesterol (TC) (p = 0.009), triglycerides (TG) (p = 0.001), CIMT (p = 0.002), weight (P = 0.001), waist circumference (p = 0.024), and systolic and diastolic blood pressure (p < 0.001), and a significant increase in TAC (p < 0.001) in comparison to the placebo. Pain score significantly increased in both groups; however, its increase was significantly higher in the placebo group compared with the intervention group (p = 0.007). No significant changes were observed between the two groups in terms of serum fibrinogen, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and quality of life indices. CONCLUSION Curcumin-piperine supplementation had beneficial effects on CIMT, serum hs-CRP, TC, TG, TAC, and systolic and diastolic blood pressure in patients with ischemic stroke in the rehabilitation stage.
-
5.
Efficacy of curcumin plus piperine co-supplementation in moderate-to-high hepatic steatosis: A double-blind, randomized, placebo-controlled clinical trial.
Sharifi, S, Bagherniya, M, Khoram, Z, Ebrahimi Varzaneh, A, Atkin, SL, Jamialahmadi, T, Sahebkar, A, Askari, G
Phytotherapy research : PTR. 2023;(6):2217-2229
Abstract
Non-alcoholic Fatty Liver Disease (NAFLD) is a global health problem that can progress to steatohepatitis and cirrhosis. The aim of this study was to determine the effect of curcumin + piperine on cardiometabolic risk factors, as well as hepatic steatosis and fibrosis in NAFLD patients with moderate-to-high hepatic steatosis. Patients diagnosed with moderate-to-high NAFLD by liver sonography were randomized to either curcumin + piperine (500 mg/day curcumin plus 5 mg/day piperine) for 12 weeks (n = 30) or placebo groups (n = 30). Liver fibroscan, anthropometric measurements, dietary intake, physical activity, blood pressure, lipid profile, high-sensitivity C-reactive protein, fasting blood glucose (FBG), and liver enzymes were assessed at baseline and after 12 weeks of follow-up. Intention-to-treat analysis was undertaken. Curcumin + piperine decreased waist circumference (p = 0.026), systolic blood pressure (p = 0.001), total cholesterol (p = 0.004), low-density lipoprotein-cholesterol (p = 0.006), FBG (p = 0.002), alanine transaminase (p = 0.007) and aspartate transaminase (p = 0.012) compared with placebo. However, fibroscan measurement did not differ between curcumin + piperine and placebo groups (p > 0.05). Fibroscan measurement as a marker of NAFLD improvement did not differ after 12 weeks of curcumin + piperine; however, curcumin + piperine may be considered as an adjunct therapy to improve anthropometric measures, blood pressure, lipid profile, blood glucose, and liver function in NAFLD patients.
-
6.
The effect of a low renal acid load diet on blood pressure, lipid profile, and blood glucose indices in patients with type 2 diabetes: a randomized clinical trial.
Armin, M, Heidari, Z, Askari, G, Iraj, B, Clark, CCT, Rouhani, MH
Nutrition journal. 2023;(1):18
Abstract
BACKGROUND Observational studies have reported that dietary renal acid load has an important role in insulin resistance and metabolic factors. The aim of the present study was to assess the effect of a low renal acid load diet (LRALD) on blood pressure, lipid profile, and blood glucose indices in patients with type 2 diabetes. METHODS In this parallel randomized clinical trial, 80 patients with type 2 diabetes were randomly assigned to the LRALD (n = 40) or control (n = 40) groups, for 12 weeks. Both groups received a balanced diet and a list of nutritional recommendations based on healthy eating behaviors. In the LRALD group, food items with low renal acid load were prescribed. Primary outcomes including: fasting blood glucose (FBG), hemoglobin A1c (HbA1c), fasting serum insulin, quantitative insulin sensitivity check index (QUICKI), homeostatic model assessment for insulin resistance (HOMA) and secondary outcomes including: weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), triglyceride (TG), total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL). were measured at baseline and end of the study. The present trial was registered at IRCT.ir (IRCT20130903014551N5). RESULTS Seventy subjects completed the study (n = 35 in control group and n = 36 in LRALD). Weight (P < 0.001), body mass index (P < 0.001), FBG (P < 0.001), HbA1c (P < 0.001), SBP (P = 0.004), and TG (P = 0.049) were reduced and HDL (P = 0.002) was increased in both groups, compared with baseline. After adjusting for baseline values, DBP (P = 0.047) was reduced in the LRALD group compared with control group. Results had no changes after using intention to treat analysis. CONCLUSION A LRALD may decrease DBP in type 2 diabetic patients. However, it elicited no significant effect on lipid profile compared with a healthy diet. TRIAL REGISTRATION This randomized clinical trial was registered at IRCT.ir (IRCT20130903014551N5).
-
7.
The effects of propolis supplementation on high-sensitivity C-reactive protein, testosterone hormone, and metabolic profile in women with polycystic ovary syndrome: A randomized, triple-blinded, placebo-controlled clinical trial.
Abbasi, E, Bagherniya, M, Soleimani, D, Ghasemi-Tehrani, H, Abbaspour, M, Clark, CCT, Askari, G
Phytotherapy research : PTR. 2023;(11):5366-5377
Abstract
One of the most prevalent ovulation disorders is polycystic ovarian syndrome (PCOS). According to the anti-inflammatory and beneficial effects of propolis, this triple-blind controlled trial was designed to evaluate the effect of propolis on metabolic factors, high-sensitivity C-reactive protein, and testosterone in women with PCOS. Recruited patients from the gynecologist clinic were randomized based on a stratified permuted four-block randomization procedure to supplement with propolis tablets, two tablets/day (500 mg propolis/day) (n = 30) or identical placebo tablets (n = 30) for 12 weeks in 2021 until 2022. Data were collected using a demographic questionnaire, blood samples, and a checklist to record the measured parameters. A total of 57 patients completed the trial. ANCOVA test showed that hip circumference (HC)) p = 0.03), fasting insulin (p = 0.007), homeostatic model assessment for insulin resistance (p = 0.004), testosterone (p = 0.004), and low-density lipoprotein (LDL)/high-density lipoprotein (HDL) (p = 0.02) were significantly decreased in the propolis versus the placebo group after adjustment for confounders. Although fasting blood glucose (p = 0.04) decreased significantly in the propolis group compared to the placebo, after adjusting for confounders, significance was lost (p = 0.09). Supplementation with propolis elicited positive effects on fasting insulin and insulin resistance, in addition to reducing the testosterone level, LDL/HDL, and HC, in PCOS women.
-
8.
Evaluation of Curcumin-Piperine Supplementation in COVID-19 Patients Admitted to the Intensive Care: A Double-Blind, Randomized Controlled Trial.
Askari, G, Bagherniya, M, Kiani, Z, Alikiaii, B, Mirjalili, M, Shojaei, M, Hassanizadeh, S, Vajdi, M, Feizi, A, Majeed, M, et al
Advances in experimental medicine and biology. 2023;:413-426
Abstract
BACKGROUND Curcumin is a traditional remedy for diseases associated with hyper-inflammatory responses and immune system impairment. Piperine, a bioactive compound in black pepper, has the potential to enhance curcumin bioavailability. 0This study aims to examine the effect of the curcumin-piperine co-supplementation in patients infected with SARS-CoV-2 and admitted to the intensive care unit (ICU). MATERIAL AND METHODS In this parallel randomized, double-blind, placebo-controlled trial, 40 patients with COVID-19 admitted to ICU were randomized to receive three capsules of curcumin (500 mg)-piperine (5 mg) or placebo for 7 days. RESULTS After 1 week of the intervention, serum aspartate aminotransferase (AST) (p = 0.02) and C-reactive protein (CRP) (p = 0.03) were significantly decreased, and hemoglobin was increased (p = 0.03) in the curcumin-piperine compared to the placebo group. However, compared with the placebo, curcumin-piperine had no significant effects on the other biochemical, hematological, and arterial blood gas and 28-day mortality rate was three patients in each group (p = 0.99). CONCLUSION The study results showed that short-term curcumin-piperine supplementation significantly decreased CRP, AST, and increased hemoglobin in COVID-19 patients admitted to the ICU. Based on these promising findings, curcumin appears to be a complementary treatment option for COVID-19 patients, although some parameters were not affected by the intervention.
-
9.
Effect of soy isoflavones supplementation on migraine characteristics, mental status and calcitonin gene-related peptide (CGRP) levels in women with migraine: results of randomised controlled trial.
Babapour, M, Khorvash, F, Rouhani, MH, Ghavami, A, Ghasemi-Tehrani, H, Heidari, Z, Karbasi, M, Moradi, F, Askari, G
Nutrition journal. 2022;21(1):50
-
-
-
Free full text
Plain language summary
Migraine is considered as an intense unilateral throbbing headache, often accompanied by nausea, vomiting, photophobia and phonophobia, which can be exacerbated by routine physical activity. It has been shown that cytokines levels are altered in migraineurs. Cytokines are inflammatory mediators that can stimulate calcitonin gene-related peptide (CGRP) [amino acid] transcription. The aim of this study was to investigate the effects of soy isoflavones supplementation on migraine headache characteristics, mental status, quality of life and CGRP concentration in adult women with migraine. This study is a double-blind, placebo-controlled clinic trial. Participants (n=88 women) were randomly assigned to one of the two groups: intervention or placebo groups (1:1). Patients in the intervention group received one tablet containing 50 mg isoflavones. Results indicate that consumption of 50 mg/day soy isoflavones supplementation for 8 weeks led to significant reduction in frequency, duration, and clinical indices of migraine and improved quality of life and CGRP levels. However, severity of migraine headache and mental status including depression, stress and anxiety were not affected by supplementation. Authors conclude that even though their findings were promising, further studies focusing on the mental status dimensions including depression, stress and anxiety are needed.
Abstract
BACKGROUND Literature suggests a relationship between estrogen levels and migraine headache pathogenesis. However, the effect of soy isoflavones on migraine characteristic remains unclear. This study aimed to investigate the effect of soy isoflavones on migraine characteristics and calcitonin gene-related peptide (CGRP) levels in women with migraine. METHODS Eighty-three participants completed a randomized double-blind controlled trial, receiving 50 mg per day soy isoflavones or placebo supplementation for 8 weeks. Migraine severity, migraine days per month, frequency and duration of attacks, mental status, quality of life and serum CGRP levels were measured at baseline and the end of the intervention. Bivariate comparison and intention-to-treat (ITT) were used for analysis. RESULTS Soy isoflavones intake resulted in a significant decrease in mean frequency (-2.36 vs -0.43, P < 0.001), duration (-2.50 vs -0.02, P < 0.001) of migraine attacks and CGRP level (-12.18 ng/l vs -8.62, P = 0.002) in compared to placebo group. Also, a significant improvement was found in quality of life (16.76 vs 2.52, P < 0.001). Although, reduction in the migraine severity and mental status did not reach a statistically significant level (P > 0.05). CONCLUSION soy isoflavones supplementation may be considered as a complementary treatment for women with migraine to improve migraine characteristics and reduce the burden of disease.
-
10.
The beneficial effect of Alpha-lipoic acid supplementation as a potential adjunct treatment in episodic migraines.
Kelishadi, MR, Naeini, AA, Khorvash, F, Askari, G, Heidari, Z
Scientific reports. 2022;12(1):271
-
-
-
Free full text
Plain language summary
Migraine and headaches can be a seriously debilitating disorder for those who suffer from them. The exact cause is still unknown; however, it is thought that inflammation in the body and the blood vessels which serve the brain may be part of the problem. Alpha-lipoic acid (ALA) is a nutrient that is found in foods such as broccoli and organ meats and it is also produced within the body. It has been shown to have anti-inflammatory effects and therefore may be of benefit to those individuals who have headaches and migraines. This 12-week randomised control study of 92 individuals with migraine aimed to determine the effects of ALA supplementation on measures of inflammation in the blood vessels and symptoms. The results showed that oxygen passage to the brain was improved, which resulted in an improvement to migraine severity and frequency. It was concluded that ALA supplementation could be considered a possible migraine treatment in conjunction with regular pain medications for migraine symptoms. This study could be used by healthcare professionals to recommend the consumption of ALA as part of migraine management.
Abstract
The current study was performed to evaluate the effects of alpha-lipoic acid (ALA) supplementation on lactate, nitric oxide (NO), vascular cell adhesion molecule-1 (VCAM-1) levels, and clinical symptoms in women with episodic migraines. Considering the inclusion and exclusion criteria, ninety-two women with episodic migraines participated in this randomized, double-blind, placebo-controlled, parallel-design trial. The participants were randomly assigned to receive either 300 mg/day ALA or placebo, twice per day for 12 weeks. The primary outcomes included headache severity, headache frequency per month, and duration of attacks and the secondary outcomes included lactate (a marker of mitochondrial function), NO, and VCAM-1 serum levels were measured at baseline and the end of the intervention. At the end of the study, there was a significant decrease in lactate serum levels (- 6.45 ± 0.82 mg/dl vs - 2.27 ± 1.17 mg/dl; P = 0.039) and VCAM-1 (- 2.02 ± 0.30 ng/ml vs - 1.21 ± 0.36 ng/ml; P = 0.025) in the ALA as compared to the placebo group. In addition, the severity (P < 0.001), frequency (P = 0.001), headache impact test (HIT-6) (P < 0.001), headache dairy results (HDR) (P = 0.003), and migraine headache index score (MHIS) (P < 0.001) had significantly decreased in the intervention as compared to the control group. No significant changes were observed for NO levels and duration of migraine pains. ALA supplementation can be considered a potential adjunct treatment in patients with migraine due to its improving mitochondrial and endothelial functions and clinical symptoms.