Allogenic Adipose Tissue-Derived Stromal/Stem Cells and Vitamin D Supplementation in Patients With Recent-Onset Type 1 Diabetes Mellitus: A 3-Month Follow-Up Pilot Study.

Objective: To evaluate the short term safety and potential therapeutic effect of allogenic adipose tissue-derived stromal/stem cells (ASCs) + cholecalciferol in patients with recent-onset T1D. Methods: Prospective, phase II, open trial, pilot study in which patients with recent onset T1D received ASCs (1 × 106 cells/kg) and cholecalciferol 2000 UI/day for 3 months (group 1) and were compared to controls with standard insulin therapy (group 2). Adverse events, C-peptide (CP), insulin dose, HbA1c, time in range (TIR), glucose variability (continuous glucose monitoring) and frequency of CD4+FoxP3+ T-cells (flow cytometry) were evaluated at baseline (T0) and after 3 months (T3). Results: 13 patients were included (8: group 1; 5: group 2). Their mean age and disease duration were 26.7 ± 6.1 years and 2.9 ± 1.05 months. Adverse events were transient headache (n = 8), mild local reactions (n = 7), tachycardia (n = 4), abdominal cramps (n = 1), thrombophlebitis (n = 4), mild floaters (n = 2), central retinal vein occlusion (n = 1, complete resolution). At T3, group 1 had lower insulin requirement (0.22 ± 0.17 vs. 0.61±0.26IU/Kg; p = 0.01) and HbA1c (6.47 ± 0.86 vs. 7.48 ± 0.52%; p = 0.03) than group 2. In group 1, 2 patients became insulin free (for 4 and 8 weeks) and all were in honeymoon at T3 (vs. none in group 2; p = 0.01). CP variations did not differ between groups (-4.6 ± 29.1% vs. +2.3 ± 59.65%; p = 0.83). Conclusions: Allogenic ASCs + cholecalciferol without immunosuppression was associated with stability of CP and unanticipated mild transient adverse events in patients with recent onset T1D. ClinicalTrials.gov registration: NCT03920397.

Additive effect of linseed oil supplementation on the lipid profiles of older adults.

BACKGROUND: Linseed oil has been investigated as a rich source of n-3 series polyunsaturated fatty acids, which mainly produce a non-atherogenic lipid profile. The objective of this study was to investigate the effect of linseed oil supplementation associated with nutritional guidelines on the lipid profiles of older adults, according to the intake of saturated fatty acids (SFA). METHODS: We conducted a double-blind, placebo-controlled clinical trial with 110 older adults randomized in two groups: placebo and linseed oil. The linseed oil group received supplementation with 3 g of linseed oil. Both groups received nutritional guidance and were supplemented for 90 days with monthly blood collection for biochemical analysis. The dietary intake of saturated fat was subdivided into low (<7% SFA/day of the total energy value) and high consumption groups (>7% SFA/day of the total energy value). RESULTS: Low SFA (<7% SFA/day of total energy value) consumption was associated with lower total cholesterol concentrations. However, we observed that the linseed oil group, including older adults who consumed >7% SFA/day, had a greater reduction in total cholesterol than the placebo group (P=0.020). The same was observed for low-density lipoprotein (LDL) cholesterol (P<0.050), suggesting an additive effect of linseed oil and diet. High-density lipoprotein (HDL) cholesterol concentrations were increased significantly in only the linseed group, suggesting that the nutritional intervention alone did not improve HDL cholesterol. CONCLUSION: The results suggest that the nutritional intervention was effective, but linseed oil showed notable effects by increasing the HDL cholesterol concentration. In addition, consumption of <7% SFA/day of the total energy value increased the effect of linseed oil, demonstrating the importance of reducing the consumption of saturated fat.

Effects of Dietary Supplementation with Brazil Nuts on Microvascular Endothelial Function in Hypertensive and Dyslipidemic Patients: A Randomized Crossover Placebo-Controlled Trial.

OBJECTIVE: To investigate the effects of dietary supplementation with GBNs on microvascular endothelial function in hypertensive and dyslipidemic patients. METHODS: Ninety-one patients of both sexes aged 62.1 ± 9.3 years received 13 g/day of GBNs or a placebo for three months with a washout period of one month between treatments. Microvascular endothelial function was assessed using LSCI coupled with iontophoresis of ACh and PORH. We also used skin video capillaroscopy to measure capillary density and recruitment at rest and during PORH. Plasma concentrations of NOx were also measured as a marker of nitric oxide bioavailability. RESULTS: Supplementation with GBNs significantly increased the plasma levels of Se (p < 0.05) and NOx (p < 0.05). However, we did not observe any effects of GBN consumption on microvascular vasodilator responses to ACh or PORH (p > 0.05), and GBNs did not improve capillary density at baseline or recruitment during PORH (p > 0.05). CONCLUSIONS: Supplementation with GBNs induced significant increases in the plasma Se concentration and systemic bioavailability of nitric oxide. Nevertheless, GBN supplementation did not lead to any improvement in systemic microvascular reactivity or density in patients with arterial hypertension and dyslipidemia who were undergoing multiple drug therapies.

Intake of partially defatted Brazil nut flour reduces serum cholesterol in hypercholesterolemic patients--a randomized controlled trial.

OBJECTIVE: Thyroid hormones can lower levels of atherogenic lipoproteins, and selenium is important in thyroid hormone homeostasis. We aimed to investigate the effects of a healthy diet associated with the Brazil nut (Bertholletia excelsa) in dyslipidemic and hypertensive patients. METHODS: This study was a randomized, placebo-controlled, double-blind trial. Seventy-seven dyslipidemic and hypertensive patients already receiving lipid-lowering drugs received either a dietary treatment associated with partially defatted Brazil nut flour (13 g/day providing 227,5 µg of selenium/day),or with dyed cassava flour as a placebo. All patients received a personalized dietary guideline with nutritional recommendations for dyslipidemia and hypertension and were followed for 90 days. RESULTS: The Brazil nut group showed reductions in total cholesterol (-20.5 ± 61.2 mg/dL, P = 0.02), non HDL-cholesterol (-19.5 ± 61.2 mg/dL, P = 0.02) and Apo A-1 (-10.2 ± 26.7 mg/dL, P = 0.03) without significant alterations in the Apo B/Apo A-1 ratio. The placebo group showed a reduction in FT3 levels (-0.1 ± 0.4, P = 0.03) and increased Lp(a) levels (5.9 ± 18.0 mg/dL, P = 0.02). There were no statistical differences in blood pressure and serum lipids between Brazil nut and placebo group. CONCLUSIONS: Supplementation with Brazil nuts seems to favor the maintenance of FT3 levels and contributes to lipemia reduction in hypercholesterolemic and euthyroid patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01990391.

Improvement of antioxidant status after Brazil nut intake in hypertensive and dyslipidemic subjects.

OBJECTIVES: To investigate the effect of partially defatted Granulated Brazil nut (GBN) on biomarkers of oxidative stress and antioxidant status of hypertensive and dyslipidemic patients on nutrition and drug approaches. METHODS: Ninety one hypertensive and dyslipidemic subjects of both genders (51.6 % men), mean age 62.1 ± 9.3 years, performed a randomized crossover trial, double-blind, placebo controlled. Subjects received a diet and partially defatted GBN 13 g per day (≈227.5 µg/day of selenium) or placebo for twelve weeks with four-week washout interval. Anthropometric, laboratory and clinic characteristics were investigated at baseline. Plasma selenium (Se), plasma glutathione peroxidase (GPx3) activity, total antioxidant capacity (TAC), 8-epi PGF2α and oxidized LDL were evaluated at the beginning and in the end of each intervention. RESULTS: GBN intake significantly increased plasma Se from 87.0 ± 16.8 to 180.6 ± 67.1 µg/L, increased GPx3 activity in 24,8% (from 112.66 ± 40.09 to 128.32 ± 38.31 nmol/min/mL, p < 0,05), and reduced 3.25% of oxidized-LDL levels (from 66.31 ± 23.59 to 60.68 ± 20.88 U/L, p < 0.05). An inverse association between GPx3 and oxidized LDL levels was observed after supplementation with GBN by simple model (ß -0.232, p = 0.032) and after adjustment for gender, age, diabetes and BMI (ß -0.298, p = 0.008). There wasn't association between GPx3 and 8-epi PGF2α (ß -0.209, p = 0.052) by simple model. CONCLUSION: The partially defatted GBN intake has a potential benefit to increase plasma selenium, increase enzymatic antioxidant activity of GPx3 and to reduction oxidation in LDL in hypertensive and dyslipidemic patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01990391; November 20, 2013.

The association of selenium status with thyroid hormones and anthropometric values in dyslipidemic patients / Relación entre los niveles de selenio, las hormonas tiroideas y la antropometría en pacientes con dislipidemia

Background: Selenium (Se) is an essential micronutrient that performs physiological functions in the metabolism of thyroid hormone and may have an association with anthropometric variables relevant to cardiovascular disease. Aim: To study the associations between Se status, thyroid hormones and anthropometric variables in dyslipidemic patients. Methods: Eighty-three patients were assessed in a cross-sectional study. Blood samples were analyzed for Se and thyroid hormones. Anthropometric measurements were taken, and dietary Se intake was investigated. Results: Mean plasma Se concentrations were low in the patients, at 88.7 ± 16.7 µg/L. Patients with plasma Se ≥ 95 µg/L were found to have a higher body mass index (BMI) (30.74 ± 4.31 vs 27.68 ± 5.63 kg/m2 , P = 0.02) and waist-to-height ratio (0.65 ± 0.05 vs 0.59 ± 0.07, P = 0.003) when compared to those with concentrations between 80 and 94 µg/L. Se intake associated positively with T3 L/T4 L ratio (r = 0.273; P= 0.03), BMI (r= 0.257, P= 0.04) and WC (r= 0.299, P= 0.02). Conclusion: The patients with the highest normal plasma Se concentrations were found to have increases in the anthropometric variables we investigated. There is a need for further study in order to elucidate these findings. Furthermore, we found a positive association between Se intake and the most metabolically active form of the thyroid hormones (AU)

Contexto: El selenio (Se) es un micronutriente esencial que realiza las funciones fisiológicas en el metabolismo de la hormona tiroidea y pueden tener una asociación con las variables antropométricas pertinentes a la enfermedad cardiovascular. Objetivo: Estudiar la asociación entre el estado de Se, hormonas tiroideas y las variables antropométricas en pacientes con dislipidemia. Métodos: Ochenta y tres pacientes fueron evaluados en un estudio transversal. Se analizaron muestras de sangre para Se y hormonas tiroideas. Las medidas antropométricas fueron tomadas, y la ingesta de la dieta Se fue investigado. Resultados: La media de las concentraciones de Se en plasma fueron bajas en los pacientes, a 88,7 ± 16,7 mg / l. Se encontró que los pacientes con niveles plasmáticos de Se ≥ 95 mg / L de tener un índice de masa corporal (IMC) (30.74 ± 4.31 vs 27.68 ± 5.63 kg / m 2, P = 0,02) y la relación cintura-estatura (0,65 ± 0,05 vs 0,59 ± 0,07, P = 0,003) en comparación con aquellos con concentraciones entre 80 y 94 g / l. Ingesta de Se asoció positivamente con relación T3L / T4L (r = 0,273, p = 0,03), índice de masa corporal (r = 0,257, P = 0,04) y WC (r = 0,299, P = 0,02). Conclusión: Se encontró que los pacientes con las más altas concentraciones de Se en plasma normal tener incrementos en las variables antropométricas que investigamos. Hay una necesidad de un mayor estudio para dilucidar estos hallazgos. Además, se encontró una asociación positiva entre el consumo de Se y la forma más metabólicamente activa de las hormonas tiroideas (AU)

The association of selenium status with thyroid hormones and anthropometric values in dyslipidemic patients.

BACKGROUND: Selenium (Se) is an essential micronutrient that performs physiological functions in the metabolism of thyroid hormone and may have an association with anthropometric variables relevant to cardiovascular disease. AIM: To study the associations between Se status, thyroid hormones and anthropometric variables in dyslipidemic patients. METHODS: Eighty-three patients were assessed in a cross-sectional study. Blood samples were analyzed for Se and thyroid hormones. Anthropometric measurements were taken, and dietary Se intake was investigated. RESULTS: Mean plasma Se concentrations were low in the patients, at 88.7 ± 16.7 µg/L. Patients with plasma Se ≥ 95 µg/L were found to have a higher body mass index (BMI) (30.74 ± 4.31 vs 27.68 ± 5.63 kg/m2, P = 0.02) and waist-to-height ratio (0.65 ± 0.05 vs 0.59 ± 0.07, P = 0.003) when compared to those with concentrations between 80 and 94 µg/L. Se intake associated positively with T3L/T4L ratio (r = 0.273; P= 0.03), BMI (r= 0.257, P= 0.04) and WC (r= 0.299, P= 0.02). CONCLUSION: The patients with the highest normal plasma Se concentrations were found to have increases in the anthropometric variables we investigated. There is a need for further study in order to elucidate these findings. Furthermore, we found a positive association between Se intake and the most metabolically active form of the thyroid hormones.

Contexto: El selenio (Se) es un micronutriente esencial que realiza las funciones fisiológicas en el metabolismo de la hormona tiroidea y pueden tener una asociación con las variables antropométricas pertinentes a la enfermedad cardiovascular. Objetivo: Estudiar la asociación entre el estado de Se, hormonas tiroideas y las variables antropométricas en pacientes con dislipidemia. Métodos: Ochenta y tres pacientes fueron evaluados en un estudio transversal. Se analizaron muestras de sangre para Se y hormonas tiroideas. Las medidas antropométricas fueron tomadas, y la ingesta de la dieta Se fue investigado. Resultados: La media de las concentraciones de Se en plasma fueron bajas en los pacientes, a 88,7 ± 16,7 mg / l. Se encontró que los pacientes con niveles plasmáticos de Se ≥ 95 mg / L de tener un índice de masa corporal (IMC) (30.74 ± 4.31 vs 27.68 ± 5.63 kg / m 2, P = 0,02) y la relación cintura-estatura (0,65 ± 0,05 vs 0,59 ± 0,07, P = 0,003) en comparación con aquellos con concentraciones entre 80 y 94 g / l. Ingesta de Se asoció positivamente con relación T3L / T4L (r = 0,273, p = 0,03), índice de masa corporal (r = 0,257, P = 0,04) y WC (r = 0,299, P = 0,02). Conclusión: Se encontró que los pacientes con las más altas concentraciones de Se en plasma normal tener incrementos en las variables antropométricas que investigamos. Hay una necesidad de un mayor estudio para dilucidar estos hallazgos. Además, se encontró una asociación positiva entre el consumo de Se y la forma más metabólicamente activa de las hormonas tiroideas.

Fortification of flours with folic acid reduces homocysteine levels in Brazilian women.

Our hypothesis is that the fortification of flour with folic acid contributes to the reduction of plasma homocysteine (Hcy). We conducted a cross-sectional study covering 2 periods, before and after fortification (2002-2003 and 2008-2009, respectively), to assess the influence of the consumption of corn and wheat flours prefortification and postfortification with folic acid on Hcy levels and other biomarkers. In the total, 93 women (38 prefortification and 55 postfortification) were included. Levels of lipids and glucose, total Hcy and serum folate, and cobalamin were determined using commercial kits by colorimetric method, competitive immunoassay, and chemiluminescence, respectively The participants' average age was 48.1 ± 9.5 years for the prefortification group and 39.1 ± 4.1 years for the postfortification group (P < .001) but adjusted statistical tests by age. Both groups presented obesity class 1. In the prefortification group, 71.1% (n = 27) of women had a dietary intake of folate, which was lower than the current recommended for adults (< 400 µg/d), whereas in the postfortification group, only 16.4% (n = 9) of women had lower intakes than recommended. In the prefortification group, 42.1% (n = 16) of women had hyperhomocysteinemia (> 10 mmol/L) compared with only 9.1% (n = 5) in the postfortification group. Moreover, statistically significant differences were found between the 2 groups in total cholesterol, high-density lipoprotein, triglycerides, and dietary fiber. Our findings corroborate the hypothesis that fortification of wheat and corn flours with folic acid can possibly be associated with lower concentrations of plasma Hcy, providing probable greater cardiovascular protection in this group.