The effects of aqueous and ethanolic extracts of Rheum ribes on insulin-resistance and apolipoproteins in patients with type 2 diabetes mellitus: a randomized controlled trial.

BACKGROUND AND AIM: Previous studies have shown that Rheum ribes (R. ribes) could be effective in controlling the blood glucose levels. This study was conducted to determine the effects of R. ribes supplementation on glycemic indices and apolipoproteins in patients with type 2 diabetes mellitus (T2DM). METHODS: In the present randomized double-blind controlled trial, 60 type 2 diabetic patients aged 30-60 years with a body mass index (BMI) of 20-30 kg/m2 and hemoglobin A1c (HbA1c) of 6-8% were enrolled. Patients were randomly assigned to receive 450 mg of aqueous R. ribes extract (AG), 450 mg of ethanolic R. ribes extract (EG), or placebo (PG) three times daily for 6 weeks. At the baseline and at the end of the study, blood glucose levels, homeostatic model assessment of insulin resistance (HOMA-IR) and the homeostatic model assessment of ß-cell dysfunction (HOMA-B), as well as apolipoprotein A-I (ApoA1) and apolipoprotein B (ApoB) were measured. RESULTS: There was a significant decrease in the serum levels of insulin in AG and EG groups (P = 0.003 and P = 0.001, respectively), HOMA-IR (P = 0.01 and P = 0.001, respectively), HOMA-B (P = 0.002 and P = 0.001, respectively), ApoB (P = 0.006 and P = 0.03, respectively), ApoB/ApoA1 ratio (P = 0.016 and P = 0.04, respectively). However, a significant increase in ApoA1 (P = 0.08 and P = 0.05, respectively) with no significant changes in blood glucose, at the end of study compared to beginning values, were observed. None of the variables showed a significant change in PG. At the end of the study; while there were significant differences in insulin (P = 0.04), HOMA-IR (P = 0.03), HOMA-B (P = 0.01), ApoB (P = 0.02), and ApoB/ApoA1 ratio (P = 0.03) among the groups but ApoA1 had no significant change. CONCLUSION: Consumption of R. ribes intake could have beneficial effects on insulin resistance and apolipoproteins in type 2 diabetic patients. (Registered at en.irct.ir, identification number: IRCT201410142709N31).

Effects of vitamin D3 supplementation on clinical symptoms, quality of life, serum serotonin (5-hydroxytryptamine), 5-hydroxy-indole acetic acid, and ratio of 5-HIAA/5-HT in patients with diarrhea-predominant irritable bowel syndrome: A randomized clinical trial.

Vitamin D deficiency, common in the population with irritable bowel syndrome (IBS), can induce the main factors that lead to IBS clinical symptoms, such as depression, anxiety, and inflammation. Serotonin (5-HT) plays an important role in the pathophysiology of IBS, and its production and secretion are increased from the lumen due to stress and inflammation. The aim of this study was to evaluate the effect of vitamin D3 supplementation on the pathogenesis of diarrhea-predominant IBS (IBS-D). Seventy-four IBS-D patients (age: 18-65 y) participated in a randomized, double-blind, placebo-controlled trial study from February 2017 to May 2018, at Rasoul-e-Akram Hospital, Tehran, Iran. Subjects were allocated into two groups receiving 50,000 IU/week of vitamin D3 or placebo for 9 weeks. IBS severity score system (IBS-SSS), IBS-quality of life questionnaire (QoL), hospital anxiety and depression Scale (HADs), visceral sensitivity index (VSI) and serum 25(OH) vitamin D3, serotonin, 5-hydroxy-indole acetic acid and ratio of 5-HIAA/5-HT were evaluated before and after the interventions. Symptoms severity, QoL, HADs-depression, and VSI score improved significantly in the vitamin D group as compared to the placebo group (P-values: <0.001, 0.049, 0.023, and 0.008; respectively). There were no significant differences in abdominal bloating, HADs-anxiety, serum 5-HT, 5-HIAA, and 5-HIAA/5-HT between the two groups at the end of the study. Based on our results, we recommend serum vitamin D be evaluated in the process of treatment of these patients to ameliorate symptoms and quality life of IBS-D patients with vitamin D deficiency and/or insufficiency.

Safety and efficacy of Melissa officinalis (lemon balm) on ApoA-I, Apo B, lipid ratio and ICAM-1 in type 2 diabetes patients: A randomized, double-blinded clinical trial.

BACKGROUND: The purpose of this study was to investigate the safety and effects of Melissa officinalis, a good source of bioactive components, on apolipoprotein (Apo)B, Apo A-I, and their ratio, lipids ratios and intercellular adhesion molecule-1(ICAM-1) in patients with type 2 diabetes. METHODS: For the present randomized, double-blinded, placebo-controlled clinical trial, 70 type 2 diabetic patients aged 20-65 years old were randomly assigned to receive hydroalcoholic extract of M. officinalis (HEMO) (700 mg/d) or placebo twice-daily for 12 weeks. RESULTS: There were significant differences in serum Apo A-I, TC/ HDL-c and LDL-c/ HDL-c between the two groups at the end of the study (p < 0.05), but we did not show significant differences in the values for Apo B, Apo B/Apo A-I, TG/HDL-c, ICAM-1 and liver enzymes include AST, ALT, and ALP between the study groups. Although both groups showed a significant reduction in ICAM-1, AST and, ALP (p < 0.05), no significant differences in ICAM-1, AST and, ALP were observed. At end, in M. officinalis group, there was a significant increase in Apo A-I (p = 0.003) and significant reduction in TG/HDL-c (p = 0.05) compared with initial values, as well as in placebo group, there was a significant rising in Apo B/Apo A-I (p = 0.02) and significant reduction in Apo A-I (p = 0.001) compared with baseline values. CONCLUSIONS: M. officinalis is safe and effective in improvement of Apo A-I, Apo B/Apo A-I, and lipids ratios as key factors promoting cardiovascular disease (CVD) in type II diabetic patients.

Effects of symbiotic and vitamin E supplementation on blood pressure, nitric oxide and inflammatory factors in non-alcoholic fatty liver disease.

Non-alcoholic fatty liver disease (NAFLD) has been suggested to be well correlated with altered blood pressure. This study was conducted to determine the effects of symbiotic and vitamin E supplementation on blood pressure and inflammatory indices of patients with NAFLD. This randomized, double-blind, placebo-controlled trial was performed among 60 NAFLD patients aged 25 to 64 years old. Participants were randomly divided into four groups to receive a 400 IU alpha-tocopherol and 2 × 108 CFU/g symbiotic supplement for 8 weeks. The anthropometric parameters, systolic blood pressure (SBP) and diastolic blood pressure (DBP), serum malondialdehyde (MDA), nitric oxide (NO) and tumor necrosis factor α (TNFα) were assessed at baseline and after 8 weeks of intervention. After 8 weeks of intervention, combined symbiotic and alpha-tocopherol, symbiotic and alpha-tocopherol alone administration, compared with the placebo, resulted in significant decreases in SBP (-17.07±2.1, -16.07±3.56, -1.73±2.25 and -1.55±3.01 mmHg, P=0.01), serum MDA (-1.19±0.5, -0.12±0.65, 0.14 ± 0.64 and 0.16±0.34 nmol/mL, P<0.001), serum TNFα (-15.62±13.93, -9.24±7.12, -11.44 ± 15.47 and 3.01±1.71 pg/ml, P<0.001) concentrations. A significant decrease in serum AST (-11.36±4.52, -7.43±8.58, -5.93±6.61 and 2.5±5.75 µmol/L, P <0.001), ALT (-12.79±3.65, -3.66±6.81, -6.54±7.66 and 4.16±3.43 µmol/L, P <0.001) and ALP (-26.8±11.1, -4.56±9.22, -14.48±12.22 and 5.19±2.64 µmol/L, P <0.001) was seen. Variations in DBP and serum NO concentration were not significant. Alpha-tocopherol and symbiotic supplementation among patients with NAFLD resulted in decreased SBP, serum MDA, TNFα levels and enzymes liver; however, they did not affect DBP and serum NO concentration.

Effect of Royal Jelly Intake on Serum Glucose, Apolipoprotein A-I (ApoA-I), Apolipoprotein B (ApoB) and ApoB/ApoA-I Ratios in Patients with Type 2 Diabetes: A Randomized, Double-Blind Clinical Trial Study.

OBJECTIVES: Type 2 diabetes is the most common metabolic disorder worldwide. Evidence supports a role for royal jelly (RJ) in reduction of serum glucose and lipids in animals and healthy subjects. The purpose of this study was to determine the effect of RJ intake on serum glucose, apolipoprotein A-I (ApoA-I), apolipoprotein B (ApoB) and ApoB/ApoA-I ratios in patients with type 2 diabetes. METHODS: Fifty patients with type 2 diabetes participated in a double-blind, placebo-controlled study. The participants were randomly divided into RJ and placebo groups and were given doses of 1000 mg royal jelly or placebo 3 times a day for 8 weeks, respectively. Weight, height, fasting blood glucose, ApoA-I and ApoB were measured at baseline and endpoint. RESULTS: There were no significant differences in baseline characteristics and dietary intakes between groups. The mean difference in glucose concentrations decreased in the RJ group (-9.4 mg/dL vs. 4 mg/dL; p=0.011). The mean difference in ApoA-I concentrations increased in the RJ group (34.4 mg/dL vs. -1.08 mg/dL; p=0.013). There was a significant decrease in mean difference of ApoB/ApoA-I in the RJ group compared with the placebo group (0.008 vs. 0.13; p<0.044), respectively. CONCLUSIONS: These data suggest that RJ intake may have desirable effects on serum glucose, Apo-A-I concentrations and ApoB/ApoA-I ratios in people with type 2 diabetes.

Effects of Iron Supplementation With and Without Docosahexaenoic Acid on the Cardiovascular Disease Risk Based on Paraoxonase-1, hs-CRP, and ApoB/ApoA-I Ratio in Women with Iron Deficiency Anemia.

Numerous studies have demonstrated that tissue deposition of iron following prolonged high dose of oral supplementation for treatment of iron deficiency anemia (IDA) leads to body iron overload and oxidative stress, which starts the process of atherosclerosis. This study aimed to determine the effect of iron supplementation in combination with docosahexaenoic acid (DHA) on the cardiovascular disease risk based on paraoxonase-1 (PON-1), high-sensitivity C-reactive protein (hs-CRP), and ApoB/ApoA-I ratio in women with IDA. In this randomized controlled trial, 76 women with IDA, aged 15-45 years, were included. The patients were randomly assigned to receive 500 mg of DHA supplement or placebo with an iron tablet, once daily for 12 weeks. The participants were assessed by measurement of the serum iron, ferritin, PON-1, hs-CRP levels, and the ApoB/ApoA-I ratio at the beginning and end of study. Serum hs-CRP decreased in the DHA-supplemented group (p = 0.036), and ApoA-I decreased in the placebo group (p = 0.013). No significant difference was detected for the serum PON-1 concentration and the ApoB/ApoA-I ratio in two groups. Iron supplementation combined with DHA may have favorable effects on serum hs-CRP in women with IDA.

The effect of ginger (Zingiber officinale) on glycemic markers in patients with type 2 diabetes.

BACKGROUND: Ginger (Zingiber officinale) is one of the functional foods which contains biological compounds including gingerol, shogaol, paradol and zingerone. Ginger has been proposed to have anti-cancer, anti-thrombotic, anti-inflammatory, anti-arthritic, hypolipidemic and analgesic properties. Here, we report the effect of ginger supplementation on glycemic indices in Iranian patients with type 2 diabetes. METHODS: A double-blind, placebo-controlled, randomized clinical trial was conducted on 20-60 -year-old patients with type 2 diabetes who did not receive insulin. Participants in the intervention and control groups were received 3 g of powdered ginger or placebo (lactose) (in capsules) daily for 3 months. Glycemic indices, total antioxidant capacity (TAC), malondialdehyde (MDA), C-reactive protein (CRP), serum paraoxonase, dietary intake and physical activity were measured at the beginning and end of the study, and after 12 h fasting. RESULTS: Comparison of the indices after 3 months showed that the differences between the ginger and placebo groups were statistically significant as follows: serum glucose (-19.41 ± 18.83 vs. 1.63 ± 4.28 mg/dL, p < 0.001), HbA1c percentage (-0.77 ± 0.88 vs. 0.02 ± 0.16%, p < 0.001), insulin (-1.46 ± 1.7 vs. 0.09 ± 0.34 µIU/mL, p < 0.001), insulin resistance (-16.38 ± 19.2 vs. 0.68 ± 2.7, p < 0.001), high-sensitive CRP (-2.78 ± 4.07 vs. 0.2 ± 0.77 mg/L, p < 0.001), paraoxonase-1 (PON-1) (22.04 ± 24.53 vs. 1.71 ± 2.72 U/L, p < 0.006), TAC (0.78 ± 0.71 vs. -0.04 ± 0.29 µIU/mL, p < 0.01) and MDA (-0.85 ± 1.08 vs. 0.06 ± 0.08 µmol/L, p < 0.001) were significantly different. CONCLUSIONS: This report shows that the 3 months supplementation of ginger improved glycemic indices, TAC and PON-1 activity in patients with type 2 diabetes.

The Effect of Sumac (Rhus coriaria L.)Powder on Serum Glycemic Status, ApoB, ApoA-I and Total Antioxidant Capacity in Type 2 Diabetic Patients.

Sumac (Rhus coriaria L.) is used as an herbal remedy in traditional medicine. The aim of this study was to determine the effects of sumac (R. coriaria) on serum glycemic status, apolipoprotein (apo) B, apoA-I and total antioxidant capacity (TAC) in type 2 diabetic patients. This double blind randomized controlled clinical trial was conducted on 41type 2 diabetic volunteers randomly assigned into 3g/day sumac powder (n=22) or placebo (n=19) groups over 3 months. Blood samples were collected before and after the intervention. Serum glucose and HbA1c were measured using enzymatic and turbidimetric inhibition immunoassay methods, respectively. ApoB, apoA-I and TAC were determined using turbidimetric immunoassay and spectrophotometric methods, respectively. There were significant decreases in serum glucose and HbA1c and also apoB levels at the end of study compared with initial values (P< 0.0001, P= 0.002 and P< 0.0001,respectively). Also, there was a significant difference in HbA1c and TAC levels between placebo and sumac groups at the end of study (P< 0.05).In sumac group, there were significant increase in apoA-I and TAC(P< 0.0001) compared with initial values. The mean of differences of serum glucose, HbA1c, apoB, apoA-I, apoB/apoA-I ratio and TAC between groups were significant (P< 0.05). In conclusion, these results showed the favorite effect of sumac consumption on serum glycemic status, apoB, apoA-I and TAC levels in in type 2 diabetic patients.

The effects of cranberry juice on serum glucose, apoB, apoA-I, Lp(a), and Paraoxonase-1 activity in type 2 diabetic male patients.

BACKGROUND: Type 2 diabetic patients are faced with a higher risk of dyslipidemia and cardiovascular disorders. This study was undertaken to assess the effect of consumption of 1 cup cranberry juice by type 2 diabetic patients on serum paraoxonase-1 (PON-1) activity, apoA-1, apoB, glucose, and Lp(a). METHODS: In a double-blind randomized clinical trial, 58 type 2 diabetic male patients were randomly divided to receive 1 cup cranberry juice (CJ) or placebo drink daily for 12 weeks. Fasting blood were obtained at beginning and at the end of study (12(th) week). Serum glucose and PON-1 activity were measured by enzymatic and colorimetric methods, respectively. ApoB, apoA-I, and Lp(a) were determined immunoturbidimetrically. The data were analyzed by SPSS version 16. RESULTS: There were significant decrease in serum glucose and apoB (P>0.05 and P>0.01, respectively) and significant increase in serum apoA-1 and PON-1 activity (P>0.05 and P<0.01, respectively) at the end of study in CJ group compared with control group. In CJ group at the end of study, there were significant decrease in serum glucose and apoB (P<0.01 and P<0.01, respectively) and significant increase in serum apo A-1 and PON-1 activity (P<0.01 and P<0.01, respectively) compared with initial values. In CJ group, there was no significant change in Lp(a) at the end of study compared with initial values and also compared with control group. CONCLUSION: 1 cup CJ for 12 weeks is effective in reducing serum glucose and apoB and increasing apoA-1 and PON-1 activity, so may have favorite effects on reducing CVD risk factors in type 2 diabetic male patients.

The Effects of Berberis vulgaris Fruit Extract on Serum Lipoproteins, apoB, apoA-I, Homocysteine, Glycemic Control and Total Antioxidant Capacity in Type 2 Diabetic Patients.

Type 2 diabetes is a well-known endocrine and metabolic disorder which has reached epidemic proportions worldwide and represents a serious public health concern. Hyperglycemia and dyslipidemia are two major abnormalities which are major cardiovascular risk factors. Berberine is a major alkaloid in Berberis vulgaris fruit extract (BVFE) which have important role in regulation of serum glucose and fat metabolism in-vivo and in-vitro but its role in type 2 diabetes have not been extensively examined. The aim of this study was the effect of BVFE on serum lipoproteins, apoB, apoA-I, homocysteine, glycemic control and total antioxidant capacity in type 2 diabetic patients. In a double-blind randomised clinical trial, 31 diabetic patients were randomly assigned to 3 g/d BVFE or placebo for 3 months. Serum glucose, lipoproteins, apoB, apoA-I, insulin, homocysteine and HbA1c were measured at the baseline and also at the end of the 3(rd) month. At the beginning and end of 1(st), 2(nd) and 3(rd) months, a 24-h dietary recall questionnaire about each patients was completed. Data were analyzed by SPSS version 16. There were significant decreases in serum TG, TC, LDL-c, apo B, glucose, and insulin and also a significant increase in TAC at the end of the study in BVFE group compared to the control group (p = 0.001, p = 0.001, p = 0.001, p = 0.001, p = 0.002, p = 0.01 and p = 0.0001 respectively). There were significant differences in serum TG (p = 0.0001), TC (p = 0.001), LDL-c (p = 0.001), apoB (p = 0.001), glucose (p = 0.002), insulin (p = 0.01), TAC (p = 0.005), and insulin resistance (p = 0.01) between the two groups at the end of the study; but homocysteine, HbA1c and HDL-c showed no significant changes between the two groups at the end of study. The intake of 3 g/d BVFE for 3 months may have benefical effects on lipoproteins, apoproteins, glycemic control and TAC in type 2 diabetic patients.

The effects of tomato consumption on serum glucose, apolipoprotein B, apolipoprotein A-I, homocysteine and blood pressure in type 2 diabetic patients.

Tomatoes are a rich source of lycopene, ß-carotene, potassium, vitamin C, flavonoids, folate and vitamin E that may provide protection against the development of type 2 diabetic patients, so the present study was undertaken to evaluate the effects of tomato intake on serum glucose, homocysteine, apolipoprotein (apo) B, apoA-I and blood pressure in type 2 diabetic patients. In a quasi-experimental study, 32 type 2 diabetes patients received 200 g raw tomato daily for 8 weeks. Serum glucose enzymatically, apoB and apoA-I immunoturbidometrically and homocysteine by high-performance liquid chromatography were measured at the beginning and end of 8 weeks. There were significant decreases in systolic and diastolic blood pressure and also a significant increase in apoA-I at the end of study compared with initial values (P = 0.0001, P = 0.0001 and P = 0.013, respectively). In conclusion, 200 g raw tomato per day had a favored effect on blood pressure and apoA-I so it might be beneficial for reducing cardiovascular risk associated with type 2 diabetes.

Effects of combination of zinc and vitamin A supplementation on serum fasting blood sugar, insulin, apoprotein B and apoprotein A-I in patients with type I diabetes.

BACKGROUND AND AIM: There is accumulating evidence that shows the metabolism of zinc and vitamin A are altered in diabetes mellitus type I (DMTI), thus the present study was conducted to evaluate the effects of combination of zinc and vitamin A supplementation on serum fasting blood sugar (FBS), insulin, apoprotein B and apoprotein A-I in patients with DMTI. DESIGN: Forty-eight, 7-year-old to 20-year-old patients with at least 2 years of DMTI history, without any metabolic condition or medicine intake with insulin treatment, participated in a randomized double-blind clinical trial for 12 weeks. They were divided into zinc and vitamin A (VAZ)-supplemented (10 mg elemental zinc per day and one-half of a 25,000 IU vitamin A tablet every other day) and/or placebo groups after matching for sex, age and DMTI duration. Nutrient intake was estimated using 24 h recall and was analyzed by food processor program. Serum apoproteins B and A-I, FBS and insulin levels were determined at the beginning and end of the trial. RESULTS: There was significant increase in apoprotein A-I (P < 0.0001) and a significant decrease in apoprotein B (P < 0.0001) and apoprotein B/apoprotein A-I ratio (P < 0.0001) at the end of the study compared with baseline values in the VAZ group but apoprotein A-I had a significant increase (P < 0.0001) and the apoprotein B/apoprotein A-I ratio had a significant decrease (P = 0.02) at the end of study in the VAZ group compared with the control group CONCLUSION: It seems that combined zinc and vitamin A supplementation can improve serum apoprotein A-I, apoprotein B and the apoprotein B/apoprotein A-I ratio in patients with DMTI.

Effects of soy bean on serum paraoxonase 1 activity and lipoproteins in hyperlipidemic postmenopausal women.

BACKGROUND/AIM: Because of an unfavorable serum lipoprotein profile, postmenopausal women are at risk of cardiovascular disease. Soy protein may help protect against these risk factors, although its effect on paraoxonase 1 (PON1) is not clear. The aim of the present study was to determine the effects of soy protein on serum concentration of lipoproteins and PON1 activity in hypercholesterolemic postmenopausal women. DESIGN: In a double-blind randomized clinical trial with a parallel design, 52 hypercholesterolemic postmenopausal women were randomly assigned to 50 g/day soy protein containing 164 mg isoflavones or placebo, for 10 weeks. Serum lipoproteins and PON1 activity were measured at baseline and at the 10th week. RESULTS: There was significant increase in PON1 activity (P=0.029) and a significant decrease in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), LDL-C/high-density lipoprotein cholesterol (HDL-C), triacylglycerol/HDL-C and TC/HDL-C in the soy group compared with the placebo group (P=0.001, P=0.008, P=0.012, P=0.04 and P=0.029, respectively) at the end of the study. Similarly, PON1 activity was significantly increased (P=0.015) and LDL-C, TC, LDL-C/HDL-C, triacylglycerol/HDL-C and TC/HDL-C were significantly decreased (P=0.001, P=0.002, P=0.001, P=0.016 and P=0.001) at the end of the study compared with the beginning value in soy group. CONCLUSION: Soy protein reduces the cardiovascular disease risk in postmenopausal women because of both modest reductions in serum lipoproteins and an increase in PON1 activity.