Effect of Nigella sativa supplementation over a one-year period on lipid levels, blood pressure and heart rate in type-2 diabetic patients receiving oral hypoglycemic agents: nonrandomized clinical trial.

BACKGROUND: Diabetic patients with hypertension and dyslipidemia are at a high risk of cardiovascular complications. OBJECTIVES: To determine the effect of Nigella sativa supplementation on the lipid profile, mean arterial pressure, and heart rate in persons with type 2 diabetes on oral hypoglycemic agents (OHA). DESIGN: Single-blind, nonrandomized. SETTING: Diabetes clinic of a university hospital in Saudi Arabia. PATIENTS AND METHODS: Type-2 diabetic patients were recruited by purposive sampling and assigned to treatment or control at the discretion of the investigator with the patient blinded to treatment. Before the in.tervention and every 3 months thereafter until the end of the treatment period, the following parameters were measured: triglycerides (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), and body mass index (BMI). Results at the baseline and each subsequent visit were compared between the two groups. MAIN OUTCOME MEASURE(S): Lipid and cardiovascular parameters, and BMI. RESULTS: Fifty-seven patients were assigned to receive N sativa 2 g daily for one year and 57 were assigned to receive an identical regimen of placebo, along with OHA. A significant decrease in HDL-C and increase in the TC/HDL-C and LDL-C/HDL-C ratios were seen in the control group. The N sativa group had a signifi.cant decline in TC, LDL-C, TC/HDL-C and LDL-C/HDL-C ratios, compared with the respective baseline data and the control group. HDL-C was significantly elevated in the N sativa group. The control group showed a significant elevation in MAP. The N sativa group had a significant reduction in SBP, DBP, MAP and HR and a significant decrease in DBP, MAP and HR as compared with the control group. CONCLUSION: N sativa supplementation improves total cholesterol, mean arterial pressure and heart rate in type 2 diabetes patients on oral hypoglycemic agents. LIMITATIONS: There were 9 subjects in each group lost to follow up; thus the sample size could not be maintained as per the sample size calculation. The study was nonrandomized and thus there was a possibility of allocation bias. (Clinical trial registration number: CTRI/2013/06/003781, Clinical Trial Registry of India).

Nigella sativa: A potential natural protective agent against cardiac dysfunction in patients with type 2 diabetes mellitus.

OBJECTIVES: To study the effect of Nigella sativa supplementation on cardiac functions in Type 2 diabetic patients treated with oral hypoglycemic agents. BACKGROUND: Diabetes mellitus is associated with a high risk of cardiovascular morbidity and mortality. A number of reported beneficial effects of N. sativa on cardiovascular function were the inspiration for this study. MATERIALS AND METHODS: Sixty patients with uncontrolled diabetes (hemoglobin A1c [HbA1c] >7%) and with no known cardiovascular complications were recruited from the outpatient diabetes clinic. They were assigned, by convenience, to two groups; the control group received activated charcoal as placebo while the test group received 2 g/day of powdered N. sativa for 1-year. All patients continued with their standard oral hypoglycemic agents. Echocardiography was used to evaluate the diastolic function, systolic function, and left ventricular mass (LVM) before the intervention and after 6 and 12 months of the treatment. RESULTS: HbA1c decreased significantly in the N. sativa group but did not change in the control group. Echocardiographic assessment in the control group showed impairment in diastolic function after 12 months, but there were no significant changes in fractional shortening (FS) or ejection fraction (EF). Furthermore, left ventricular (LV) dimensions at diastole and systole, LVM, and LVM index were significantly increased. In N. sativa group, no significant changes were found in diastolic function or LVM. LV dimension at systole was decreased while FS and EF were significantly increased after 6 and 12 months. CONCLUSION: N. sativa supplementation may protect the hearts of type 2 diabetic patients from diastolic dysfunction while improving LV systolic function.

Nigella sativa improves glycemic control and ameliorates oxidative stress in patients with type 2 diabetes mellitus: placebo controlled participant blinded clinical trial.

BACKGROUND AND OBJECTIVE: Oxidative stress plays an important role in pathogenesis of diabetes mellitus and its complications. Our previous study has shown glucose lowering effect produced by 3 months supplementation of Nigella sativa (NS) in combination with oral hypoglycemic drugs among type 2 diabetics. This study explored the long term glucose lowering effect (over one year) of NS in patients with type 2 diabetes mellitus on oral hypoglycemic drugs and to study its effect on redox status of such patients. METHODS: 114 type 2 diabetic patients on standard oral hypoglycemic drugs were assigned into 2 groups by convenience. The control group (n = 57) received activated charcoal as placebo and NS group (n = 57) received 2g NS, daily, for one year in addition to their standard medications. Fasting blood glucose (FBG), glycosylated hemoglobin (HbA1c), C- peptide, total antioxidant capacity (TAC), superoxide dismutase (SOD), catalase (CAT), glutathione and thiobarbituric acid reactive substances (TBARS) at the baseline, and every 3 months thereafter were determined. Insulin resistance and ß-cell activity were calculated using HOMA 2 calculator. RESULTS: Comparison between the two groups showed a significant drop in FBG (from 180 ± 5.75 to 180 ± 5.59 in control Vs from 195 ± 6.57 to 172 ± 5.83 in NS group), HbA1c (from 8.2 ± 0.12 to 8.5 ± 0.14 in control VS from 8.6 ± 0.13 to 8.2 ± 0.14 in NS group), and TBARS (from 48.3 ± 6.89 to 52.9 ± 5.82 in control VS from 54.1 ± 4.64 to 41.9 ± 3.16 in NS group), in addition to a significant elevation in TAC, SOD and glutathione in NS patients compared to controls. In NS group, insulin resistance was significantly lower, while ß-cell activity was significantly higher than the baseline values during the whole treatment period. CONCLUSION: Long term supplementation with Nigella sativa improves glucose homeostasis and enhances antioxidant defense system in type 2 diabetic patients treated with oral hypoglycemic drugs. TRIAL REGISTRATION: Clinical Trials Registry-India (CTRI) CTRI/2013/06/003781.

Favorable impact of Nigella sativa seeds on lipid profile in type 2 diabetic patients.

BACKGROUND AND AIM: The atherogenic pattern of dyslipidemia associated with type 2 diabetes mellitus (DM) has been increasingly discussed. We have recently reported a hypoglycemic effect of Nigella sativa (NS) seeds in patients with type 2 DM. In this study we sought to assess the impact of NS seeds on lipid profile in type 2 diabetic patients. PATIENTS AND METHOD: A total of 94 patients with type 2 DM were recruited and divided into 3 dose groups. Capsules containing NS were administered orally in a dose of 1, 2, and 3 g/day for 12 weeks. All patients were subjected to measurement of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-c), and high-density lipoprotein cholesterol (HDL-c) before treatment and 4, 8, and 12 weeks thereafter. RESULTS: Patients receiving 1 g/day NS seeds for 12 weeks (group 1) showed nonsignificant changes in all the parameters except for a significant increase in HDL-c after 4 weeks of treatment. However, patients ingested 2 g/day NS displayed a significant decline in TC, TG, and LDL-c, and a significant elevation in HDL-c/LDL-c, compared with their baseline data and to group 1 patients. Increasing NS dose to 3 g/day failed to show any increase in the hypolipdemic effect produced by the 2 g/day dose. CONCLUSION: NS supplementation at a dose of 2 g/day for 12 weeks may improve the dyslipidemia associated with type 2 diabetic patients. Therefore, NS is a potential protective natural agent against atherosclerosis and cardiovascular complications in these patients.

Effect of Nigella sativa seeds on the glycemic control of patients with type 2 diabetes mellitus.

UNLABELLED: Diabetes mellitus is a common chronic disease affecting millions of people world wide. Standard treatment is failing to achieve required correction of blood glucose in many patients. Therefore, there is a need for investigating potential hypoglycemic drugs or herbs to improve glycemic control in diabetic patients. Nigella sativa seeds were used as an adjuvant therapy in patients with diabetes mellitus type 2 added to their anti-diabetic medications. A total of 94 patient were recruited and divided randomly into three dose groups. Capsules containing Nigella sativa were administered orally in a dose of 1, 2 and 3 gm/day for three months. The effect of Nigella sativa on the glycemic control was assessed through measurement of fasting blood glucose (FBG), blood glucose level 2 hours postprandially (2 hPG), and glycosylated hemoglobin (HbA1c). Serum C-peptide and changes in body weight were also measured. Insulin resistance and beta-cell function were calculated usin the homeostatic model assessment (HOMA2). Nigella sativa at a dose of 2 gm/day caused significant reductions in FBG, 2hPG, and HbA1 without significant change in body weight. Fasting blood glucose was reduced by an average of 45, 62 and 56 mg/dl at 4, 8 and 12 weeks respectively. HbAlC was reduced by 1.52% at the end of the 12 weeks of treatment (P<0.0001). Insulin resistance calculated by HOMA2 was reduced significantly (P<0.01), while B-cell function was increased (P<0.02) at 12 weeks of treatment. The use of Nigella sativa in a dose of 1 gm/day also showed trends in improvement in all the measured parameters but it was not statistically significant from the baseline. However, no further increment in the beneficial response was observed with the 3 gm/day dose. The three doses of Nigella sativa used in the study did not adversely affect either renal functions or hepatic functions of the diabetic patients throughout the study period. IN CONCLUSION: the results of this study indicate that a dose of 2 gm/ day of Nigella sativa might be a beneficial adjuvant to oral hypoglycemic agents in type 2 diabetic patients.