The effect of a standardized capsule of Aloe vera gel on the quality of life in patients with systolic heart failure: A randomized double-blind placebo-controlled clinical trial.

This trial was designed to evaluate the effect of a standardized capsule of Aloe vera gel (AVG) on the quality of life (QOL) in patients with systolic heart failure (HF). Forty-two patients were randomly divided into two groups to receive either AVG 150 mg or harmonized placebo capsules twice a day for 8 weeks. The patients were evaluated before and after the intervention using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), New York Heart Association (NYHA) functional class, six-minute walk test (6MWT), Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI) and STOP-BANG questionnaires. Post-intervention, AVG group indicated a significant reduction in the total score of MLHFQ (p < 0.001). The changes in MLHFQ and NYHA class were statistically significant after taking medication (p < 0.001 and p = 0.004, respectively). The change of 6MWT in the AVG group was more advanced; however, it was not statistically significant (p = 0.353). Moreover, in the AVG group, the severity of insomnia and obstructive sleep apnea decreased (p < 0.001, p = 0.01 respectively) and the sleep quality improved as well (p < 0.001). There were significantly fewer adverse events reported in the AVG group (p = 0.047). Therefore, AVG combined with standard medical therapy could provide more clinical benefits for patients with systolic HF.

Potential protective effects of Aloe vera gel on cardiovascular diseases: A mini-review.

Cardiovascular diseases (CVDs) comprise the most prevalent causes of morbidity and mortality in both men and women worldwide. CVDs are associated with several risk factors such as hyperlipidemia, diabetes mellitus, hypertension, obesity, tobacco smoking and an unhealthy diet. Currently, in addition to the use of related pharmacological treatments in the management of CVDs, the investigation of other suitable healthcare approaches for these disorders such as the identification of herbal medicines has been considered in the scientific communities. Aloe vera (L.) Burm.f. is a perennial medicinal plant. The innermost leaf layer of this plant contains transparent gel, which is used as food. Pre-clinical studies have shown several biological activities of A. vera gel (AVG), including antidiabetic, lipid-lowering, antioxidant, antiinflammatory, hepatoprotective, and immunomodulatory effects. Other pharmacological activities of AVG such as anti-fibrotic, anti-hypertensive, and anti-atherosclerotic effects have been reported. Moreover, several clinical studies have demonstrated the ameliorating effects of AVG on some markers of CVDs risk factors. Thus, this study was conducted to review clinical trials besides in vitro and in vivo studies on the cardiac beneficial effects of AVG. However, further high-quality studies are needed to firmly establish the clinical efficacy of the plant.

Trends in Serum Vitamin D Levels within 12 Months after One Anastomosis Gastric Bypass (OAGB).

PURPOSE: To assess serum vitamin D trend from baseline to 12 months after one anastomosis gastric bypass (OAGB). MATERIALS AND METHODS: In this observational cohort analysis of longitudinal data, we assessed the trend of serum vitamin D, and its associations with anthropometric, and biochemical measurements in 98 patients undergoing OAGB in a bariatric surgery center. All participants were on >800 IU/day vitamin D supplementation. RESULTS: Vitamin D, lipid profile, creatinine, and albumin levels significantly improved at 12 months post-surgery. Vitamin D concentrations significantly increased from 26.52 ± 12.32 to 54.52 ± 27.90 ng/mL at 12 months. The correlations between vitamin D concentrations and weight, body mass index, lipid profile, ferritin, glycemic indices, and albumin were not significant. In addition, the correlations between vitamin D and parathormone, vitamin D receptor, calcium, phosphorus, body composition, and basal metabolic rate (BMR) did not reach the threshold of statistical significance at 12 months following bariatric surgery. Although there was a significant correlation between body weight and body composition (P < 0.001) and basal metabolic rate (BMR) (r = 0.762, P < 0.001) at 12 months, there were no significant correlations between weight change percent and body composition (P > 0.05), BMR (r = -0.101, P = 0.350), and vitamin D (r = 0.120, P = 0.271) at 12 months. CONCLUSION: Our results showed that supplementation of vitamin D with dosage of >800 IU/day is sufficient for prevention of vitamin D deficiency within 12 months after OAGB surgery. Note: This data is mandatory.

Relationship Between Modified Body Adiposity Index and A Body Shape Index with Biochemical Parameters in Bariatric Surgery Candidates.

BACKGROUND: Body mass index, an estimate of body fat percentage, has been previously shown to be associated with metabolic disorders. However, there is little data on the associations between a body shape index (ABSI) or modified body adiposity index (MBAI), which provide valuable definitions of body fat, with serum biochemical parameter levels. Therefore, this study was conducted to find either ABSI or MBAI associations with serum biochemical parameter levels in bariatric surgery candidates. METHODS: This cross-sectional study was conducted on 776 bariatric surgery candidates (age range 18-69 years) between November 2010 and September 2017. Demographic data, anthropometric indices, biochemical parameters, and body composition analysis data were drawn from the National Obesity Surgery Database, Iran. ABSI and MBAI were calculated using related equations. A stepwise multivariate linear regression was used to evaluate whether ABSI or MBAI was associated with each serum biochemical parameter. RESULTS: ABSI, age, and multivitamin/mineral supplementation (MVMS) were independently associated with serum vitamin D (ß = 24.374, SE 10.756, P value 0.026; ß = 0.022, SE 0.007, P value 0.002; ß = 0.639, SE 0.235, P value 0.008). However, a negative association was observed between MBAI and vitamin D (ß = - 0.037, SE 0.016, P value 0.025) in a model adjusted for age and MVMS. Additionally, MBAI and age showed a significant positive association with serum HDL-c (ß = 0.185, SE 0.085, P value 0.028; ß = 0.171, SE 0.033, P value < 0.001), although there was a negative association between male sex and HDL-c (ß = - 4.004, SE 0.891, P value < 0.001). CONCLUSION: ABSI and MBAI may be appropriate indices in predicting serum vitamin D and HDL-c levels.

The Effects of Probiotic Supplements on Blood Markers of Endotoxin and Lipid Peroxidation in Patients Undergoing Gastric Bypass Surgery; a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial with 13 Months Follow-Up.

BACKGROUND: The effect of probiotic supplements among subjects undergoing bariatric surgery indicates conflicting results. Moreover, whether these effects remain after ceasing the treatment remained to be elucidated. This study was conducted to assess the effect of probiotic supplements on blood markers of endotoxin (lipopolysaccharides-binding protein: LBP), inflammation and lipid peroxidation (malondialdehyde: MDA) in patients with morbid obesity undergoing the one-anastomosis gastric bypass (OAGB). METHODS: This study is a placebo-controlled, double-blind, and randomized clinical trial and 9 months of additional follow-up. Forty-six morbid obese patients undergoing OAGB were randomized to 4 months of probiotic or placebo supplements. Anthropometric indices and blood concentration of LBP, inflammatory markers, MDA, vitamin D3, and B12 were measured at 0, 4, and 13 months of study. RESULTS: Probiotic supplements could improve serum LBP (P = 0.039), TNF-α (P = 0.005), vitamin B12 (P = 0.03), vitamin D3 (P = 0.001), and weight loss (P = 0.01) at month 4 in comparison to placebo; however, only serum MDA concentrations decreased significantly in the probiotic group compared with those in the placebo group (P = 0.013) at the end of follow-up period. DISCUSSION: It was observed that 4 months probiotic supplementation compared with placebo prohibited an elevation in the LBP levels and improved serum TNF-α and 25-OH vitamin D3 concentrations and weight loss in patients undergoing the OAGB surgery. However, these effects did not persist 9 months after the cessation of the treatment. Further investigations are required to find how long supplementation and which dosage of it can benefit body status for the long-term. TRIAL REGISTRATION: This study has been registered at Clinicaltrial.gov with registration number NCT02708589 .

Probiotic Supplementation in Morbid Obese Patients Undergoing One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) Surgery: a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial.

BACKGROUND: Bariatric surgery is known as one of the most effective treatments for sustainable weight loss; however, it may be associated with some complications. This study was designed to examine the effects of probiotic supplementation on some morbidities related to this surgery. METHODS: This was a placebo-controlled, double-blind, randomized clinical trial on morbid obese patients referred for One Anastomosis Gastric Bypass- Mini Gastric Bypass (OAGB-MGB) surgery to a tertiary referral center. Patients were assigned to receive a probiotic supplement (Familact®) or placebo from 4 weeks prior to surgery to 12 weeks after surgery. Anthropometric, biochemical, and inflammatory indices were evaluated at the beginning and the end of the study. RESULTS: At the end of study, significant improvements in some serum inflammatory markers, vitamin D status, and anthropometric measurements were observed (p < 0.05), which were significantly more in probiotic group rather than placebo group (p < 0.05). Moreover, significant improvements in glycemic indices and lipid profile were observed in both groups; however, these changes were not significantly different between the groups. There was no significant difference in serum levels of vitamin B12, folate, and homocysteine between groups at week 16 of the study. DISCUSSION: Our results indicate that probiotic supplementation promotes inflammatory markers, body weight loss, and status of vitamin D in patients undergoing OAGB-MGB bypass. Whether these findings will sustain in longer treatment duration remained to be elucidated in future studies. TRIAL REGISTRATION: This study has been registered at Clinicaltrial.gov with registration number NCT02708589.

Breast-Milk Iodine Concentrations and Iodine Levels of Infants According to the Iodine Status of the Country of Residence: A Systematic Review and Meta-Analysis.

BACKGROUND: Iodine, an essential micronutrient, plays a critical role in normal growth and development, especially during the first two years of life. This systematic review and meta-analysis is among the first to evaluate breast-milk iodine concentrations and infant iodine status in countries characterized by iodine sufficiency or deficiency. METHODS: PubMed, Web of Science, Cochrane Library, Google Scholar, and other relevant databases, as well as reference lists of previous reviews, were searched for relevant studies published between 1986 and 2016. Mean or median breast-milk and infant urinary iodine concentrations, along with other relevant data, were extracted from eligible studies. Each study was assessed for quality and risk of bias. RESULTS: Of the 496 identified studies, 57 met the criteria for inclusion in the meta-analysis. The mean (confidence interval [CI]) iodine concentrations in maternal colostrum were 152.0 µg/L [CI 106.2-198.7 µg/L] and 57.8 µg/L [CI 41.4-74.1 µg/L] in iodine-sufficient and -deficient countries, respectively, indicating a significant difference between the two iodine statuses. By contrast, the corresponding values in mature milk did not differ significantly between mothers in iodine-sufficient and -deficient countries (71.5 µg/L [CI 51.0-92.0 µg/L] and 28.0 µg/L [CI -13.8 to 69.9 µg/L], respectively]. The weighted urinary iodine levels [CIs] of breast-fed infants in iodine-sufficient countries were significantly higher than those in iodine-deficient countries (164.5 µg/L [CI 116.4-212.7 µg/L] vs. 70.4 µg/L [CI 46.2-94.6 µg/L]). Similarly, a significant difference was observed in the pooled estimates of urinary iodine levels [CIs] among formula-fed infants in iodine-sufficient versus iodine-deficient countries (310.3 µg/L [CI 287.4-342.1 µg/L] vs. 38.3 µg/L [CI 23.4-53.2 µg/L]). CONCLUSION: The meta-analysis reveals that in iodine-sufficient countries, the mean iodine concentrations in colostrum and mature breast milk corresponded to iodine sufficiency among infants. The results are thus compatible with the international recommendation that lactating women and infants younger than two years of age who reside in iodine-sufficient countries do not require iodine supplementation.

The Nitrate-Independent Blood Pressure-Lowering Effect of Beetroot Juice: A Systematic Review and Meta-Analysis.

Beetroot is considered a complementary treatment for hypertension because of its high content of inorganic NO3 This systematic review and meta-analysis aimed to clarify several aspects of beetroot juice supplementation on systolic blood pressure (SBP) and diastolic blood pressure (DBP). We searched PubMed, Scopus, and Embase databases, and the reference lists of previous reviews. Randomized clinical trials that investigated the effects of beetroot juice on resting blood pressure in humans were recruited for quality assessment, meta-analyses, subgroup analyses, and meta-regressions; of these, 22 were conducted between 2009 and 2017 and included a total of 47 intervention (n = 650) and 43 control (n = 598) groups. Overall, SBP (-3.55 mm Hg; 95% CI: -4.55, -2.54 mm Hg) and DBP (-1.32 mm Hg; 95% CI: -1.97, -0.68 mm Hg) were significantly lower in the beetroot juice-supplemented groups than in the control groups. The mean difference of SBP was larger between beetroot juice-supplemented and control groups in the longer than in the shorter (≥14 compared with <14 d) study durations (-5.11 compared with -2.67 mm Hg) and the highest compared with the lowest (500 compared with 70 and 140 mL/d) doses of beetroot juice (-4.78 compared with -2.37 mm Hg). A positive correlation was observed between beetroot juice doses and the mean differences of blood pressures. In contrast, a smaller effect size of blood pressures was observed after supplementation with higher NO3 (milligrams per 100 mL beetroot juice). A weak effect size was observed in a meta-analysis of trials that used NO3-depleted beetroot juice as a placebo compared with other interventions (-3.09 compared with -4.51 mm Hg for SBP and -0.81 compared with -2.01 mm Hg for DBP). Our results demonstrate the blood pressure-lowering effects of beetroot juice and highlight its potential NO3-independent effects.

The effect of adjuvant vitamin C after varicocele surgery on sperm quality and quantity in infertile men: a double blind placebo controlled clinical trial.

Varicocele is one of the most common causes of male infertility and spontaneous pregnancy rate after varicocelectomy is only about 30%. The most important seminal antioxidant is vitamin C but recent studies about the effects of vitamin C on spermatogenesis are controversial; therefore, we decided to evaluate its role after varicocelectomy. In a double blind randomized controlled clinical trial, 115 men with infertility and clinical varicocele with abnormal semen analyses were recruited. After surgery, the intervention group received vitamin C (250 mg bid) and the control group received placebo for three months. Mean sperm count, motility, and morphology index of two semen analyses (before and after surgery) were compared between the two groups. Univariate general linear model and stepwise linear regression were used in analysis. The mean age (± SD) of participants was 27.6 ± 5.3 years. Vitamin C group had statistically significant better normal motility (20.8 vs. 12.6, P=0.041) and morphology (23.2 vs. 10.5, P<0.001) than placebo group. Considering the values prior to surgery as covariate, vitamin C was not effective on sperm count (P=0.091); but it improved sperm motility (P=0.016) and morphology (P<0.001) even after excluding the confounding effect of age (P=0.044 and P=0.001, respectively). Vitamin C was also an independent factor in predicting motility and normal morphology after surgery. Ascorbic acid can play a role as adjuvant treatment after varicocelectomy in infertile men.

The effect of adjuvant vitamin C after varicocele surgery on sperm quality and quantity in infertile men: a double blind placebo controlled clinical trial

Varicocele is one of the most common causes of male infertility and spontaneous pregnancy rate after varicocelectomy is only about 30%. The most important seminal antioxidant is vitamin C but recent studies about the effects of vitamin C on spermatogenesis are controversial; therefore, we decided to evaluate its role after varicocelectomy. In a double blind randomized controlled clinical trial, 115 men with infertility and clinical varicocele with abnormal semen analyses were recruited. After surgery, the intervention group received vitamin C (250 mg bid) and the control group received placebo for three months. Mean sperm count, motility, and morphology index of two semen analyses (before and after surgery) were compared between the two groups. Univariate general linear model and stepwise linear regression were used in analysis. The mean age (±SD) of participants was 27.6±5.3 years. Vitamin C group had statistically significant better normal motility (20.8 vs. 12.6, P=0.041) and morphology (23.2 vs. 10.5, P<0.001) than placebo group. Considering the values prior to surgery as covariate, vitamin C was not effective on sperm count (P=0.091); but it improved sperm motility (P=0.016) and morphology (P<0.001) even after excluding the confounding effect of age (P=0.044 and P=0.001, respectively). Vitamin C was also an independent factor in predicting motility and normal morphology after surgery. Ascorbic acid can play a role as adjuvant treatment after varicocelectomy in infertile men.