The effects of Bunium Persicum (Black Caraway) supplementation on glycemic indices, lipid profiles and serum levels of nesfatin-1 in overweight and obese patients with type 2 diabetes: a double-blind randomized placebo-controlled clinical trial

2020 ◽  
Author(s):  
Saber Jafari-Maskouni ◽  
Mansour Shahraki ◽  
Milad Daneshi-Maskooni ◽  
Alireza Dashipour ◽  
Ali Shamsi-Goushki ◽  
...  

Abstract Background: Diabetes mellitus is the most common metabolic disorder worldwide. Our aim was to determine the effects of bunium persicum (BP) on serum glucose indices, lipid profile, and nesfatin-1 levels among overweight or obese T2DM patients.Methods: The place of participant recruitment was the diabetic clinic of Bu-Ali hospital in Zahedan. Based on the eligibility criteria, 60 participants were randomly divided into two groups as BP (n=30) or placebo (n=30). The supplementation was one 1000 mg capsules 2 times/day BP with launch and dinner for 8 weeks. Bodyweight, Waist circumference, serum nesfatin-1, fasting blood sugar (FBS), insulin (FBI), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were measured. Quantitative insulin sensitivity checks index (QUICKI), homeostasis model assessment-insulin resistance (HOMA-IR) and Body Mass Index (BMI) were also calculated.Results: In comparison with placebo, PB significantly increased QUICKI and decreased FBS, HOMA-IR, BMI and WC (P<0.05). At the end of the study after adjustment for confounders, the changes were similar (P<0.05) with an exception for QUICKI which had a trend (P=0.054) and WC (P > 0.05). The differences in the FBI, TG, TC, LDL, HDL and Nesfatin-1 were not significant (P>0.05).Conclusion: PB supplement improved serum glucose indices and decreased BMI among overweight or obese T2DM patients; though, further trials are suggested to confirm results.

2020 ◽  
Author(s):  
Saber Jafari-Maskouni ◽  
Mansour Shahraki ◽  
Milad Daneshi-Maskooni ◽  
Alireza Dashipour ◽  
Ali Shamsi-Goushki ◽  
...  

Abstract Background: Diabetes mellitus is the most common metabolic disorder worldwide. We aimed to determine the effects of Bunium Persicum (BP) on serum glucose indices, lipid profile, and nesfatin-1 levels in overweight or obese T2DM patients.Methods: Participant recruitment took place in the diabetic clinic of Bu-Ali hospital in Zahedan. Based on the eligibility criteria, 60 participants were randomly divided into two groups, namely BP (n=30) and placebo (n=30). The supplementation was one 1000 mg capsule 2 times /day BP with meals (lunch and dinner) for 8 weeks. Bodyweight, waist circumference, serum nesfatin-1, fasting blood sugar (FBS) and insulin (FBI), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were measured. Quantitative insulin sensitivity checks index (QUICKI), homeostasis model assessment-insulin resistance (HOMA-IR), and Body Mass Index (BMI) were also calculated.Results: In comparison with placebo, BP significantly decreased FBS, HOMA-IR, and BMI (P<0.05). The differences in the FBI, QUICKI, TG, TC, LDL, HDL, WC, and Nesfatin-1 were not significant (P>0.05).Conclusion: BP supplement improved serum glucose indices and decreased BMI among overweight or obese T2DM patients; though, further trials are suggested to confirm results.Trial Registration: Iranian Registry of Clinical Trials (IRCT), IRCT20181207041876N1, Registered 18/01/2019, https://irct.ir/trial/35752


2020 ◽  
Author(s):  
Saber Jafari-Maskouni ◽  
Mansour Shahraki ◽  
Milad Daneshi-Maskooni ◽  
Alireza Dashipour ◽  
Ali Shamsi-Goushki ◽  
...  

Abstract Background : Diabetes mellitus is the most common metabolic disorder worldwide. We aimed to determine the effects of Bunium Persicum (BP) on serum glucose indices, lipid profile, and nesfatin-1 levels in overweight or obese T2DM patients. Methods : Participant recruitment took place in the diabetic clinic of Bu-Ali hospital in Zahedan. Based on the eligibility criteria, 60 participants were randomly divided into two groups, namely BP (n=30) and placebo (n=30). The supplementation was one 1000 mg capsule 2 times /day BP with meals (lunch and dinner) for 8 weeks. Bodyweight, waist circumference, serum nesfatin-1, fasting blood sugar (FBS) and insulin (FBI), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were measured. Quantitative insulin sensitivity checks index (QUICKI), homeostasis model assessment-insulin resistance (HOMA-IR) and Body Mass Index (BMI) were also calculated. Results : In comparison with placebo, BP significantly decreased FBS, HOMA-IR, and BMI (P<0.05). The differences in the FBI, QUICKI, TG, TC, LDL, HDL,WC and Nesfatin-1 were not significant (P>0.05). Conclusion : BP supplement improved serum glucose indices and decreased BMI among overweight or obese T2DM patients; though, further trials are suggested to confirm results. Trial Registration : Iranian Registry of Clinical Trials (IRCT), IRCT20181207041876N1, Registered 18/01/2019, https://irct.ir/trial/35752


2021 ◽  
Vol 13 (4) ◽  
pp. 314-319
Author(s):  
Mahdiyeh Khabbaz Koche Ghazi ◽  
Samad Ghaffari ◽  
Mohammad Naemi ◽  
Rezvaniyeh Salehi ◽  
Mohammadreza Taban Sadeghi ◽  
...  

Introduction: Atherosclerosis and related cardiovascular diseases (CVDs) are the major causes of mortality worldwide. The available reports regarding the effects of selenium (Se) supplementation in the realm of atherosclerosis have been equivocal. The present investigation is aimed to assess the effects of sodium selenite and Se-enriched yeast supplementation on metabolic parameters among atherosclerotic patients. Methods: In this double-blind placebo-controlled randomized clinical trial, 60 patients diagnosed with atherosclerosis were randomly allocated into either 200 μg/day selenite, yeast, or placebo groups for eight consecutive weeks. Serum levels of lipid profile and glycemic indices were measured at the baseline and end of the intervention. Results: There were no significant within-or between-group changes in levels of total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-c), fasting blood sugar, insulin, and homeostatic model assessment for IR throughout the study (P≥0.05). Only the low density lipoprotein cholesterol (LDL-c) levels were significantly lower in the yeast group in comparison with the placebo group (P= 0.015). Conclusion: The administration of Se-enriched yeast is significantly effective in decreasing LDL-c levels in patients with atherosclerosis. Additional clinical trial studies investigating the effect of Se administration on glucose homeostasis parameters and lipid profiles in atherosclerotic patients are suggested for a more definitive conclusion.


2000 ◽  
Vol 28 (2) ◽  
pp. 47-68 ◽  
Author(s):  
W Insull ◽  
J Isaacsohn ◽  
P Kwiterovich ◽  
P Ma ◽  
R Brazg ◽  
...  

This pivotal, multicentre, double-blind, parallel-group study evaluated the efficacy and safety of cerivastatin 0.8 mg. Patients with primary hypercholesterolaemia were randomized, after 10 weeks' dietary stabilization on an American Heart Association (AHA) Step I diet, to treatment with cerivastatin 0.8 mg ( n = 776), cerivastatin 0.4 mg ( n = 195) or placebo ( n = 199) once daily for 8 weeks. Cerivastatin 0.8 mg reduced mean low density lipoprotein-cholesterol (LDL-C) by 41.8% compared with cerivastatin 0.4 mg (–35.6%, P < 0.0001) or placebo. In 90% of patients receiving cerivastatin 0.8 mg LDL-C was reduced by 23.9–58.4% (6th–95th percentile). Overall attainment of the National Cholesterol Education Program (NCEP) goal was achieved by 84% of patients receiving cerivastatin 0.8 mg and by 59% of those with coronary heart disease (CHD). In the sub-population meeting the NCEP criteria for pharmacological therapy for LDL-C reduction, 74.6% of patients, including the 59% with CHD, reached the goal with cerivastatin 0.8 mg. Cerivastatin 0.8 mg also reduced mean total cholesterol by 29.9%, apolipoprotein B by 33.2% and median triglycerides by 22.9% (all P < 0.0001). Mean high density lipoprotein-cholesterol (HDL-C) and apolipoprotein A1 were elevated 8.7% ( P < 0.0001) and 4.5% ( P < 0.0001), respectively, by cerivastatin 0.8 mg. Reductions of triglyceride and elevation in HDL-C were dependent upon triglyceride baseline levels; in patients having baseline triglyceride levels 250–400 mg/dl, cerivastatin 0.8 mg reduced median triglycerides by 29.5% and elevated HDL-C by 13.2%. Cerivastatin 0.8 mg was well tolerated. The most commonly reported adverse events included headache, pharyngitis and rhinitis (4–6%). Symptomatic creatine kinase elevations > 10 times upper limit of normal occurred in 0%, 1% and 0.9% of patients receiving placebo, cerivastatin 0.4 mg or cerivastatin 0.8 mg, respectively. Cerivastatin 0.8 mg is an effective and safe treatment for patients with primary hypercholesterolaemia who need aggressive LDL-C lowering in order to achieve NCEP-recommended levels.


2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Alireza Niknafs ◽  
Mohammadreza Rezvanfar ◽  
Mohammad Kamalinejad ◽  
Seyed Amirhosein Latifi ◽  
Amir Almasi-Hashiani ◽  
...  

Introduction. It has been well established in the world that lipid disorders promote the development of atherosclerosis and its clinical consequences. This study aimed to assess the impacts of a Persian medicinal (PM) compound on lipid profile. Materials and Methods. From June 21 to October 21, 2020, a randomized double-blind controlled clinical trial was conducted with 74 dyslipidemic patients, who were randomly divided into two equally populated groups: one prescribed with a Persian medicinal herbal compound (n = 37) and a placebo group (n = 37). A Persian herbal medicine including fenugreek, sumac, and purslane is introduced. Biochemical parameters including 12-hour fasting serum levels of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very-low-density lipoprotein (VLDL), and triglyceride (TG) were measured before the initiation and after the completion of study protocol. Results. Percent changes of biochemical parameters include the following: intervention group = cholesterol: 35.22, Tg: 45.91, LDL: 24.81, HDL: 2.05, VLDL: 8.94 and placebo group = cholesterol: 6.94, Tg: −7.3, LDL: 7.37, HDL: 2.88, VLDL: −0.14. The serum levels of total cholesterol ( p = 0.01 ) and LDL ( p = 0.01 ) significantly decreased and no increase was recorded in HDL ( p = 0.03 ) levels over time in the intervention group. Furthermore, between-group analysis showed a statistically significant difference between the intervention and placebo groups in this regard. VLDL ( p = 0.2 ) and TG ( p = 0.2 ) levels also decreased, however not significantly. Conclusion. This study showed that a Persian medicinal herbal compound could be safe and beneficial to decrease the levels of serum cholesterol and LDL in dyslipidemic patients. However, larger long-term studies are recommended to clarify this effect.


2016 ◽  
Vol 134 (3) ◽  
pp. 234-239 ◽  
Author(s):  
Hassan Argani ◽  
Amir Ghorbanihaghjo ◽  
Hamid Vatankhahan ◽  
Nadereh Rashtchizadeh ◽  
Sina Raeisi ◽  
...  

ABSTRACT: CONTEXT AND OBJECTIVE: Red grape seed extract (RGSE) contains oligomeric proanthocyanidin complexes as a class of flavonoids. These compounds are potent antioxidants and exert many health-promoting effects. This study aimed to determine the effects of RGSE on serum levels of triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein AI (apo-AI) levels and paraoxonase (PON) activity in patients with mild to moderate hyperlipidemia (MMH). DESIGN AND SETTINGS: A randomized double-blind placebo-controlled clinical trial was conducted at Shahid-Modarres Hospital (Tehran, Iran) and Tabriz University of Medical Sciences. Seventy MMH patients were randomly assigned to receive treatment (200 mg/day of RGSE) or placebo for eight weeks. RESULTS: Significant elevation in serum levels of apo-AI (P = 0.001), HDL-C (P = 0.001) and PON activity (P = 0.001) and marked decreases in concentrations of TC (P = 0.015), TG (P = 0.011) and LDL-C (P = 0.014) were found in the cases. PON activity was significantly correlated with apo-AI (r = 0.270; P < 0.01) and HDL-C (r = 0.45; P < 0.001). Significant differences between the RGSE and control groups (before and after treatment) for TC (P = 0.001), TG (P = 0.001), PON (P = 0.03), apo-AI (P = 0.001) and LDL-C (P = 0.002) were seen. CONCLUSION: It is possible that RGSE increases PON activity mostly through increasing HDL-C and apo-AI levels in MMH patients. It may thus have potential beneficial effects in preventing oxidative stress and atherosclerosis in these patients.


2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Kausik K. Ray ◽  
Stefano Del Prato ◽  
Dirk Müller-Wieland ◽  
Bertrand Cariou ◽  
Helen M. Colhoun ◽  
...  

Abstract Background Individuals with diabetes often have high levels of atherogenic lipoproteins and cholesterol reflected by elevated low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and LDL particle number (LDL-PN). The presence of atherosclerotic cardiovascular disease (ASCVD) increases the risk of future cardiovascular events. We evaluated the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, alirocumab, among individuals with type 2 diabetes (T2DM), high LDL-C or non-HDL-C, and established ASCVD receiving maximally tolerated statin in ODYSSEY DM-DYSLIPIDEMIA (NCT02642159) and DM-INSULIN (NCT02585778). Methods In DM-DYSLIPIDEMIA, individuals with T2DM and mixed dyslipidemia (non-HDL-C ≥ 100 mg/dL; n = 413) were randomized to open-label alirocumab 75 mg every 2 weeks (Q2W) or usual care (UC) for 24 weeks, with UC options selected before stratified randomization. In DM-INSULIN, insulin-treated individuals with T2DM (LDL-C ≥ 70 mg/dL; n = 441) were randomized in a double-blind fashion to alirocumab 75 mg Q2W or placebo for 24 weeks. Study participants also had a glycated hemoglobin < 9% (DM-DYSLIPIDEMIA) or < 10% (DM-INSULIN). Alirocumab dose was increased to 150 mg Q2W at week 12 if week 8 LDL-C was ≥ 70 mg/dL (DM-INSULIN) or non-HDL-C was ≥ 100 mg/dL (DM-DYSLIPIDEMIA). Lipid reductions and safety were assessed in patients with ASCVD from these studies. Results This analysis included 142 DM-DYSLIPIDEMIA and 177 DM-INSULIN participants with ASCVD, including 95.1% and 86.4% with coronary heart disease, and 32.4% and 49.7% with microvascular diabetes complications, respectively. At week 24, alirocumab significantly reduced LDL-C, non-HDL-C, ApoB, and LDL-PN from baseline versus control. This translated into a greater proportion of individuals achieving non-HDL-C < 100 mg/dL (64.6% alirocumab/23.8% UC [DM-DYSLIPIDEMIA]; 65.4% alirocumab/14.9% placebo [DM-INSULIN]) and ApoB < 80 mg/dL (75.1% alirocumab/35.4% UC and 76.8% alirocumab/24.8% placebo, respectively) versus control at week 24 (all P < 0.0001). In pooling these studies, 66.4% (alirocumab) and 67.0% (control) of individuals reported treatment-emergent adverse events. The adverse event pattern was similar with alirocumab versus controls. Conclusions Among individuals with T2DM and ASCVD who had high non-HDL-C/LDL-C levels despite maximally tolerated statin, alirocumab significantly reduced atherogenic cholesterol and LDL-PN versus control. Alirocumab was generally well tolerated. Trial registration Clinicaltrials.gov. NCT02642159. Registered 30 December 2015 and Clinicaltrials.gov. NCT02585778. Registered 23 October 2015


Author(s):  
J. H. Osorio ◽  
J. D. Flores

Objective: To compare serum levels of total cholesterol, triglycerides, low density lipoprotein cholesterol and high density lipoprotein cholesterol between broilers and laying hens. Materials and Methods: the present is a cross study, descriptive and analytic. Data was analyzed using simple ANOVA, the program Statgraphics Plus 5.1 was used. The study was performed at Universidad de Caldas in Manizales (Colombia). After fasting, blood from 30 broilers (Cobb 500 line) of 35-day-old and 40 laying hens (Hy-Line W-36 line) of 26-weeks-old. Serum levels of triglycerides, total cholesterol, low density lipoprotein cholesterol and high density lipoprotein cholesterol was measured by enzymatic colorimetric methods, direct method (detergent + N,Nbis (4-sulfobutyl)-m-toluidine) was used for the lipoprotein cholesterol. Results: Between broilers (Cobb 500 line) and (laying hens (Hy-line W-36 line) was significant difference in serum levels of triglycerides and in serum levels of high density lipoprotein cholesterol (P <0.05); serum levels of total cholesterol and serum levels of low density lipoprotein cholesterol, no differences were found (P> 0.05) Conclusions: Despite differences in gender, age, and production system among broilers Cobb 500 line and laying hens Hy-Line W-36, no differences were found between serum total cholesterol and low density lipoprotein cholesterol.


2020 ◽  
Vol 105 (3) ◽  
pp. e835-e847 ◽  
Author(s):  
Fiona Yuen ◽  
Arthi Thirumalai ◽  
Cindy Pham ◽  
Ronald S Swerdloff ◽  
Bradley D Anawalt ◽  
...  

Abstract Background 11β-methyl-19-nortestosterone (11β-MNT) is a modified testosterone (T) with androgenic and progestational activity. A single oral dose of the prodrug, 11β-MNT dodecylcarbonate (11β-MNTDC), was well tolerated in healthy men. Methods We conducted a randomized, double-blind study at 2 academic medical centers. 42 healthy men (18–50 years) were randomized to receive oral placebo or 11β-MNTDC, 200 or 400 mg daily, for 28 consecutive days. Primary outcome (safety and tolerability) measures were assessed twice per week. Subjects underwent serial blood sampling over 24 hours on days 1 and 28 to assess secondary outcomes: pharmacokinetics (serum drug concentrations); pharmacodynamics of 11β-MNTDC (serum sex steroids and gonadotropins); and mood and sexual function (via validated questionnaires). Results There were no serious adverse events. No participants discontinued because of an adverse event or laboratory test abnormality. 11β-MNTDC resulted in a dose-related increase in serum 11β-MNTDC and 11β-MNT concentrations sustained over 24 hours. Administration of 11β-MNTDC resulted in a marked suppression of serum gonadotropins, T, calculated free T, estradiol, and SHBG over the treatment period (P &lt; 0.01). Adverse effects that may be related to 11β-MNTDC included weight gain, acne, headaches, fatigue, and mild mood changes, with 5 men reporting decreased libido and 3 decreased erectile/ejaculatory function. Serum low-density lipoprotein cholesterol, weight (~2 kg), hematocrit, and hemoglobin increased and serum high-density lipoprotein cholesterol decreased in both 11β-MNTDC groups. Conclusion Daily oral 11β-MNTDC for 28 days in healthy men markedly suppressed serum gonadotropin and T concentrations without serious adverse effects. These results warrant further evaluation of 11β-MNTDC as a potential male oral contraceptive.


2015 ◽  
Vol 5 (1) ◽  
pp. 1 ◽  
Author(s):  
Mohamed Aboubakr ◽  
Abdelazem Mohamed Abdelazem

<p>The study was designed to evaluate the hepatoprotective activity of aqueous extract of cardamom in acute experimental liver injury induced by gentamicin. Twenty four male albino rats were randomly divided into four groups (six rats in each). Animals of the first group served as control and orally (p.o.) received (1 ml/kg saline). The second experimental group was given gentamicin (80 mg/kg i.p.) for 7 days. Third and fourth groups were given aqueous extract of cardamom (100 and 200 mg/kg p.o.) + gentamicin for 7 days, respectively. The degree of hepatoprotection was measured using serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, albumin, and lipid profile levels. In the acute liver damage induced by gentamicin, cardamom aqueous extracts (100 and 200 mg/kg, p.o.) significantly reduced the elevated serum levels of AST, ALT, bilirubin, cholesterol, triglycerides and low density lipoprotein cholesterol (LDL-chol) in gentamicin induced hepatotoxicity. Also cardamom aqueous extracts (100 &amp; 200 mg/kg, p.o.) significantly increased the lowered serum levels of albumin and high density lipoprotein cholesterol (HDL-chol) in gentamicin induced hepatotoxicity rats. Histopathological examination of the liver tissues supported the hepatoprotection. Our findings concluded that cardamom aqueous extracts possessed hepatoprotective activity against gentamicin induced hepatotoxicity in rats.</p>


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