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Superiority of magnesium and vitamin B6 over magnesium alone on severe stress in healthy adults with low magnesemia: A randomized, single-blind clinical trial.
Pouteau, E, Kabir-Ahmadi, M, Noah, L, Mazur, A, Dye, L, Hellhammer, J, Pickering, G, Dubray, C
PloS one. 2018;13(12):e0208454
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Magnesium (Mg) plays a role in over 600 biochemical reactions. It is depleted during stress, and a lack of Mg increases the release of stress hormones, leading to a vicious cycle of lowered resistance to stress and further Mg depletion. Vitamin B6 influences neurotransmitters involved in depression and anxiety, and may improve the uptake of magnesium into cells. The aim of this randomised control trial was to evaluate the effects of combined magnesium and vitamin B6 supplementation in stressed people with low blood levels of magnesium. 260 adults aged 18-50 completed the 8-week study. At the beginning of the trial, all participants had suboptimal blood serum magnesium (0.45 mmol/L to 0.85 mmol/L) and reported moderate to extremely severe stress levels. Participants were divided into two groups. One group received magnesium supplementation (465mg magnesium lactate dihydrate, equivalent to 300mg elemental magnesium; Mg), whilst the other received a combined magnesium and vitamin B6 supplement (470 mg magnesium lactate dihydrate plus 5 mg pyridoxine hydrochloride; Mg-B6). After 8 weeks, the Mg-B6 group reported a reduction in stress levels of 44.9%, and the Mg group reported a reduction of 42.4%, with no statistical difference between the two groups overall. However, participants who reported severe or extremely severe stress levels at the start of the study experienced 24% greater improvement with Mg-B6 versus Mg. Researchers concluded that in people with low magnesium levels experiencing severe or extremely severe stress, combining vitamin B6 with magnesium appears to be of greater benefit than supplementing Mg alone.
Abstract
INTRODUCTION Animal and clinical studies suggest complementary effects of magnesium and high-dose pyridoxine (vitamin B6) on stress reduction. This is the first randomized trial evaluating the effects of combined magnesium and vitamin B6 supplementation on stress in a stressed population with low magnesemia using a validated measure of perceived stress. METHODS In this Phase IV, investigator-blinded trial (EudraCT: 2015-003749-24), healthy adults with Depression Anxiety Stress Scales (DASS-42) stress subscale score >18 and serum magnesium concentration 0.45 mmol/L-0.85 mmol/L, were randomized 1:1 to magnesium-vitamin B6 combination (Magne B6 [Mg-vitamin B6]; daily dose 300 mg and 30 mg, respectively) or magnesium alone (Magnespasmyl [Mg]; daily dose 300 mg). Outcomes included change in DASS-42 stress subscale score from baseline to Week 8 (primary endpoint) and Week 4, and incidence of adverse events (AEs). RESULTS In the modified intention-to-treat analysis (N = 264 subjects), both treatment arms substantially reduced DASS-42 stress subscale score from baseline to Week 8 (Mg-vitamin B6, 44.9%; Mg 42.4%); no statistical difference between arms was observed (p>0.05). An interaction (p = 0.0097) between baseline stress level and treatment warranted subgroup analysis (as per statistical plan); adults with severe/extremely severe stress (DASS-42 stress subscale score ≥25; N = 162) had a 24% greater improvement with Mg-vitamin B6 versus Mg at Week 8 (3.16 points, 95% CI 0.50 to 5.82, p = 0.0203). Consistent results were observed in the per protocol analysis and at Week 4. Overall, 12.1% of Mg-vitamin B6 treated and 17.4% of Mg-treated subjects experienced AEs potentially treatment related. CONCLUSIONS These findings suggest oral Mg supplementation alleviated stress in healthy adults with low magnesemia and the addition of vitamin B6 to Mg was not superior to Mg supplementation alone. With regard to subjects with severe/extremely severe stress, this study provides clinical support for greater benefit of Mg combined with vitamin B6.
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A plant-based diet in overweight individuals in a 16-week randomized clinical trial: metabolic benefits of plant protein.
Kahleova, H, Fleeman, R, Hlozkova, A, Holubkov, R, Barnard, ND
Nutrition & diabetes. 2018;8(1):58
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Suboptimal nutrition is a major cause of obesity, chronic disease, and premature death across the nation and worldwide. The aim of this study was to explore the effects of plant protein, as part of a plant-based diet, on weight control, body composition, and insulin resistance in overweight individuals. This study is a secondary analysis of data from a 16-week randomized clinical trial. Participants were randomly assigned in a 1:1 ratio to a vegan or a control group. Results indicate that: - the quality and quantity of dietary protein from a plant-based vegan diet are associated with improvements in body composition, body weight, and insulin resistance in overweight individuals. - decreased intake of animal protein and an increased intake of plant protein were associated with a decrease in fat mass. - decreased histidine [amino acid] intake was associated with a decrease in insulin resistance. - decreased intake of the amino acids threonine, leucine, lysine, methionine, and tyrosine were each associated with a decrease in insulin resistance (mainly driven by weight loss). Authors conclude that there is the need for additional research to explore the mechanisms explaining the beneficial role of plant protein and specific amino acids in regulating body weight, body composition, and insulin resistance.
Abstract
BACKGROUND AND OBJECTIVES A plant-based diet is an effective strategy in the treatment of obesity. In this 16-week randomized clinical trial, we tested the effect of a plant-based diet on body composition and insulin resistance. As a part of this trial, we investigated the role of plant protein on these outcomes. SUBJECTS AND METHODS Overweight participants (n = 75) were randomized to follow a plant-based (n = 38) or a control diet (n = 37). Dual X-ray Absorptiometry assessed body composition, Homeostasis Model Assessment (HOMA-IR) assessed insulin resistance, and a linear regression model was used to test the relationship between protein intake, body composition, and insulin resistance. RESULTS The plant-based vegan diet proved to be superior to the control diet in improving body weight, fat mass, and insulin resistance markers. Only the vegan group showed significant reductions in body weight (treatment effect -6.5 [95% CI -8.9 to -4.1] kg; Gxt, p < 0.001), fat mass (treatment effect -4.3 [95% CI -5.4 to -3.2] kg; Gxt, p < 0.001), and HOMA-IR (treatment effect -1.0 [95% CI -1.2 to -0.8]; Gxt, p = 0.004). The decrease in fat mass was associated with an increased intake of plant protein and decreased intake of animal protein (r = -0.30, p = 0.011; and r = +0.39, p = 0.001, respectively). In particular, decreased % leucine intake was associated with a decrease in fat mass (r = +0.40; p < 0.001), in both unadjusted and adjusted models for changes in BMI and energy intake. In addition, decreased % histidine intake was associated with a decrease in insulin resistance (r = +0.38; p = 0.003), also independent of changes in BMI and energy intake. CONCLUSIONS These findings provide evidence that plant protein, as a part of a plant-based diet, and the resulting limitation of leucine and histidine intake are associated with improvements in body composition and reductions in both body weight and insulin resistance.
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Anti-Inflammatory Effects of a Vegan Diet Versus the American Heart Association-Recommended Diet in Coronary Artery Disease Trial.
Shah, B, Newman, JD, Woolf, K, Ganguzza, L, Guo, Y, Allen, N, Zhong, J, Fisher, EA, Slater, J
Journal of the American Heart Association. 2018;7(23):e011367
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Inflammation plays a central role in the progression of atherosclerosis and is associated with adverse cardiovascular events. The aim of this study was to determine the effects of a vegan versus American Heart Association (AHA)-recommended diet on high-sensitivity C-reactive protein (hsCRP) [a type of protein found in blood plasma], as well as other markers of inflammation, glucometabolic markers, and lipid profiles in patients with established coronary artery disease (CAD) on guideline-directed medical therapy. This study is a prospective, randomized, open-label, blinded end point study design. The active study duration was 8 weeks, with an interim visit at 4 weeks and a final visit at 8 weeks. Results show: - a significantly greater reduction in hsCRP with a vegan versus AHA-recommended diet in patients with established CAD on guideline-directed medical therapy. - that the degree of weight loss, as measured by both body mass index and waist circumference, did not significantly differ between the 2 diet groups. - that markers of glycaemic control and lipid profiles, overall, also did not significantly differ in the vegan diet group when compared with the AHA-recommended diet group. Authors conclude that in patients with CAD and an elevated hsCRP, despite guideline-directed medical therapy, a vegan diet may be considered to further lower the parameters of inflammation.
Abstract
Background Dietary interventions may play a role in secondary cardiovascular prevention. hsCRP (High-sensitivity C-reactive protein) is a marker of risk for major adverse cardiovascular outcomes in coronary artery disease. Methods and Results The open-label, blinded end-point, EVADE CAD (Effects of a Vegan Versus the American Heart Association-Recommended Diet in Coronary Artery Disease) trial randomized participants (n=100) with coronary artery disease to 8 weeks of a vegan or American Heart Association-recommended diet with provision of groceries, tools to measure dietary intake, and dietary counseling. The primary end point was high-sensitivity C-reactive protein. A linear regression model compared end points after 8 weeks of a vegan versus American Heart Association diet and adjusted for baseline concentration of the end point. Significance levels for the primary and secondary end points were set at 0.05 and 0.0015, respectively. A vegan diet resulted in a significant 32% lower high-sensitivity C-reactive protein (β, 0.68, 95% confidence interval [0.49-0.94]; P=0.02) when compared with the American Heart Association diet. Results were consistent after adjustment for age, race, baseline waist circumference, diabetes mellitus, and prior myocardial infarction (adjusted β, 0.67 [0.47-0.94], P=0.02). The degree of reduction in body mass index and waist circumference did not significantly differ between the 2 diet groups (adjusted β, 0.99 [0.97-1.00], P=0.10; and adjusted β, 1.00 [0.98-1.01], P=0.66, respectively). There were also no significant differences in markers of glycemic control between the 2 diet groups. There was a nonsignificant 13% reduction in low-density lipoprotein cholesterol with the vegan diet when compared with the American Heart Association diet (adjusted β, 0.87 [0.78-0.97], P=0.01). There were no significant differences in other lipid parameters. Conclusions In patients with coronary artery disease on guideline-directed medical therapy, a vegan diet may be considered to lower high-sensitivity C-reactive protein as a risk marker of adverse outcomes. Clinical Trial Registration URL http://www.clinicaltrials.gov . Unique identifier: NCT 02135939.
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Men and women respond differently to rapid weight loss: Metabolic outcomes of a multi-centre intervention study after a low-energy diet in 2500 overweight, individuals with pre-diabetes (PREVIEW).
Christensen, P, Meinert Larsen, T, Westerterp-Plantenga, M, Macdonald, I, Martinez, JA, Handjiev, S, Poppitt, S, Hansen, S, Ritz, C, Astrup, A, et al
Diabetes, obesity & metabolism. 2018;20(12):2840-2851
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Overweight and obesity are major risk factors for developing type 2 diabetes mellitus. Men and women respond differently to weight loss programmes, with men typically losing more weight and more abdominal fat, whilst women lose more subcutaneous fat. The aim of this large multinational study was to compare the effects of weight loss induced by an 8‐week low energy diet on metabolic outcomes in overweight men and women with prediabetes. Study participants followed the Cambridge Weight Plan which is based on four formula meals, with a total of approximately 810kcal, per day, for eight weeks. Small amounts of non-starchy vegetables were allowed, as were psyllium husks in case of digestive problems. Men lost significantly more weight than women, 11.8% versus 10.3%. Insulin resistance improved similarly in men and women, but metabolic syndrome score improved more in men than in women. Men lost more fat than women and generally had more beneficial metabolic changes. Women had higher reductions in fat-free mass, bone mineral content and HDL cholesterol than men, raising the question whether rapid weight loss may have negative longer term effects for women.
Abstract
AIMS: The PREVIEW lifestyle intervention study (ClinicalTrials.gov Identifier: NCT01777893) is, to date, the largest, multinational study concerning prevention of type-2 diabetes. We hypothesized that the initial, fixed low-energy diet (LED) would induce different metabolic outcomes in men vs women. MATERIALS AND METHODS All participants followed a LED (3.4 MJ/810 kcal/daily) for 8 weeks (Cambridge Weight Plan). Participants were recruited from 8 sites in Europe, Australia and New Zealand. Those eligible for inclusion were overweight (BMI ≥ 25 kg/m2 ) individuals with pre-diabetes according to ADA-criteria. Outcomes of interest included changes in insulin resistance, fat mass (FM), fat-free mass (FFM) and metabolic syndrome Z-score. RESULTS In total, 2224 individuals (1504 women, 720 men) attended the baseline visit and 2020 (90.8%) completed the follow-up visit. Following the LED, weight loss was 16% greater in men than in women (11.8% vs 10.3%, respectively) but improvements in insulin resistance were similar. HOMA-IR decreased by 1.50 ± 0.15 in men and by 1.35 ± 0.15 in women (ns). After adjusting for differences in weight loss, men had larger reductions in metabolic syndrome Z-score, C-peptide, FM and heart rate, while women had larger reductions in HDL cholesterol, FFM, hip circumference and pulse pressure. Following the LED, 35% of participants of both genders had reverted to normo-glycaemia. CONCLUSIONS An 8-week LED induced different effects in women than in men. These findings are clinically important and suggest gender-specific changes after weight loss. It is important to investigate whether the greater decreases in FFM, hip circumference and HDL cholesterol in women after rapid weight loss compromise weight loss maintenance and future cardiovascular health.
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The Effects of Extra Virgin Olive Oil on Alanine Aminotransferase, Aspartate Aminotransferase, and Ultrasonographic Indices of Hepatic Steatosis in Nonalcoholic Fatty Liver Disease Patients Undergoing Low Calorie Diet.
Shidfar, F, Bahrololumi, SS, Doaei, S, Mohammadzadeh, A, Gholamalizadeh, M, Mohammadimanesh, A
Canadian journal of gastroenterology & hepatology. 2018;2018:1053710
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Non-alcoholic fatty liver disease (NAFLD) is a risk factor for cardiovascular disease (CVD), which is the most common cause of death. The traditional Mediterranean diet has been shown to reduce the risk of NAFLD and CVD and this protective effect is thought to be in part due to the use of olive oil in this dietary pattern. The aim of this randomised, single-blind study was to evaluate the effect of virgin olive oil as part of a low-calorie diet on markers of NAFLD. 43 overweight or obese patients with NAFLD, characterised by increased liver enzymes (ALT and AST), were randomised to either a low calorie diet with normal fat or a low calorie diet with 20% of total energy intake from olive oil (overall percentage of fat 30% of total energy intake in both groups) for three months. Significant weight loss was observed in both groups, with no significant difference between groups. There was a reduction in liver enzymes in the olive oil group which was significantly greater than in the control group. The severity of liver steatosis (the accumulation of fat in the liver) did not change significantly in either group. The authors concluded that a low calorie diet with virgin olive oil led to slight weight loss and improvements in markers for NAFLD.
Abstract
Background: Coronary artery disease is the most common cause of death in the patients with nonalcoholic fatty liver disease (NAFLD). Studies have shown that there is a strong relation between the increase in the aminotransferase levels and fat accumulation in the liver with cardiovascular complications, independent of all aspects of the metabolic syndrome. This study aimed to examine the effect of virgin olive oil on alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the severity of steatosis in the NAFLD patients undergoing a weight-loss diet. Methods: This clinical trial was carried out on 50 patients with nonalcoholic fatty liver (mean age of 45.91 ± 9.61 years, mean BMI of 29.7 ± 0.58 Kg/m2) and the subjects were randomly assigned to the olive oil group (receiving the equivalent of 20% of their total daily energy requirement from olive oil) or the control group (with normal consumption of oil) for 12 weeks. All the patients received a hypocaloric diet during the study. At the beginning and the end of the study, the serum levels of ALT and AST and liver steatosis were measured. Findings: A significant decrease in the level of ALT enzymes was observed in the control group at the end of the study (P = 0.004). In the olive oil group, both enzymes decreased compared to baseline measurements (P < 0.01). There were significant differences in the ALT and AST levels between the two groups (P < 0.02). The severity of liver steatosis did not change significantly during the study. Conclusion: The consumption of a low calorie diet enriched with olive oil, along with slight weight reduction, reinforces the desired effects of weight loss in improving the levels of the hepatic enzymes.
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Evaluation of a 12-week lifestyle education intervention with or without partial meal replacement in Thai adults with obesity and metabolic syndrome: a randomised trial.
Chaiyasoot, K, Sarasak, R, Pheungruang, B, Dawilai, S, Pramyothin, P, Boonyasiri, A, Supapueng, O, Jassil, FC, Yamwong, P, Batterham, RL
Nutrition & diabetes. 2018;8(1):23
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Obesity and metabolic syndrome (MetS) have markedly increased in many low- and middle-income countries, such as Thailand, as a consequence of economic growth, increased urbanisation and adoption of a ‘western’ lifestyle. Weight-loss interventions by reducing energy intake and increasing physical activity through behavioural modification are the mainstay of the treatment of obesity and MetS, but poor compliance is a problem. The aim of this randomised study was to evaluate the effect of a low-cost lifestyle education intervention (LEI) alone or a LEI with meal replacements (LEI + MR) in Thai adults with obesity and MetS for 12 weeks. The lifestyle education was delivered by a dietitian and comprised a group session at baseline with advice on diet and physical activity, followed by four individual sessions at weeks 2, 4, 8 and 12. In addition, the LEI + MR group also received two meal replacement formula meals per day. The LEI+MR group lost more weight than the LEI group, 2.86% versus 1.53%. Weight loss was maintained at 26 weeks after the end of the intervention, but had gone back to baseline after another 26 weeks. Overall, the LEI+MR group had better outcomes in blood sugar control and metabolic syndrome scores. The authors conclude that both LEI and LEI + MR are acceptable for Thai patients with obesity and MetS and lead to modest weight loss and improvement in MetS and blood sugar control, with the LEI + MR group showing greater benefits at 12 weeks
Abstract
BACKGROUND/OBJECTIVES There have been no studies examining the efficacy of meal replacement (MR) on weight loss and metabolic syndrome (MS) improvement in Southeast Asians. Thus, we undertook a 12-week randomised trial to evaluate the effect of a lifestyle education intervention alone (LEI) or with partial MR (LEI + MR) in obese Thai adults with MS. SUBJECTS/METHODS A total of 110 patients were randomised to receive either LEI or LEI + MR. Both groups received LEI to achieve weight loss. LEI + MR group additionally received two MR daily to replace either breakfast, lunch or dinner. Mean ± SE body mass index of all participants was 34.6 ± 0.6 kg/m2, mean ± SE age was 42.5 ± 1.1 years and 83% of patients were female. Both groups were compared for anthropometric and cardiometabolic indices at 12-week. Body weight was also compared at weeks 38 and 64. RESULTS At 12 weeks, both groups exhibited statistically significant percentage weight loss (%WL) compared to initial weight but greater %WL was observed in LEI + MR compared to LEI, 2.9% vs. 1.5%, respectively (p < 0.05). MS criteria such as waist circumference and blood pressure improved significantly in both groups compared to baseline. However, improvement in fasting plasma glucose (FPG) was only significant in LEI + MR, and more participants with impaired FPG at baseline in LEI + MR (42.9%) than LEI (19%) returned to normal FPG at 12 weeks (p < 0.05). HbA1c, fasting insulin and HOMA-IR in LEI + MR were significantly lower than with LEI. At the end of the 12-week intervention period, 16% of participants no longer fulfilled MS criteria. A statistically significant weight loss from baseline persisted until 38 weeks but no longer reached statistically significant difference between groups CONCLUSIONS LEI and LEI + MR were acceptable and led to improvement in weight and MS. LEI + MR group exhibited additional weight reduction and glycemic benefits at 12 weeks.
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Weight loss and metabolic health effects from energy-restricted Mediterranean and Central-European diets in postmenopausal women: A randomized controlled trial.
Bajerska, J, Chmurzynska, A, Muzsik, A, Krzyżanowska, P, Mądry, E, Malinowska, AM, Walkowiak, J
Scientific reports. 2018;8(1):11170
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During menopause women commonly gain weight, in particular around the waist. This abdominal obesity is a risk factor for diabetes and heart disease. The aim of this randomised trial in Poland was to compare the effectiveness of two energy-restricted diets on weight loss and metabolic syndrome (MetS) in post-menopausal women with abdominal obesity and at least one other marker for MetS. The diets used were the Mediterranean diet (MED), which is moderate in fat, in particular mono-unsaturated fat, and the so-called Central European diet (CED), which is low in fat, moderate in carbohydrates, and high in dietary fiber (DF) derived from central European food items. Participants were counselled on their respective diet plans and provided with one prepared main meal per day and followed their diet for 16 weeks. Both groups had a significant weight loss (7.5kg MED, 7.7kg CED), reductions in waist circumference (7.4cm both), fat mass and abdominal fat. Both groups also had significant improvements in blood sugar control, blood pressure, homocysteine and triglycerides but not in LDL and HDL cholesterol. There were no significant differences between groups for any of the outcomes. Adherence to the respective diets decreased over the course of the study for both the MED and the CED and weight loss was highest for those who adhered best to the respective diet. The authors concluded that short-term dietary treatment using the CED or the MED was associated with similar improvements in weight and markers of MetS.
Abstract
We conducted a randomized controlled trial to examine the effect of two energy-restricted diets on body weight (BW), visceral fat (VF) loss, and the risk factors for metabolic syndrome. A total of 144 centrally obese postmenopausal women were assigned to the moderate in fat Mediterranean diet (MED) or to the Central European diet (CED), which is moderate in carbohydrates and high in dietary fiber (DF), for 16 weeks. BW, waist circumference and VF were significantly reduced by 8.8%, 7.0%, and 24.6%, respectively, over the trial (P < 0.001), with no difference between groups. A similar trend was seen for total cholesterol, triglycerides, glucose, and blood pressure. Within each diet group, the more adherent participants lost significantly more BW than did their less adherent counterparts. VF was significantly reduced only in women who were more adherent to the CED, and the reduction in VF correlated with an increase in the proportion of DF. Short-term dietary treatment with the CED or the MED was associated with similar improvements in some anthropometric, lipid, and nonlipid parameters; however, adequate adherence to the prescribed diet is important in weight loss success and in achieving improvements in metabolic health.
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A Khorasan Wheat-Based Replacement Diet Improves Risk Profile of Patients With Nonalcoholic Fatty Liver Disease (NAFLD): A Randomized Clinical Trial.
Dinu, M, Whittaker, A, Pagliai, G, Giangrandi, I, Colombini, B, Gori, AM, Fiorillo, C, Becatti, M, Casini, A, Benedettelli, S, et al
Journal of the American College of Nutrition. 2018;37(6):508-514
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Non-alcoholic fatty liver disease (NAFLD) is prevalent, however early intervention with lifestyle modifications such as weight loss, dietary therapy and physical activity may reverse it. Previous studies have shown that the Mediterranean diet, which includes a large proportion of grains, may reduce NAFLD. However no prior studies have assessed grains in isolation on these individuals. This randomised double blind parallel arm study aimed to assess the effects of a replacement diet with ancient khorasan wheat products on patients with NAFLD. 40 people with mild- moderate NAFLD were assigned to either khorasan wheat diet or a modern wheat grain diet for three months. This comparatively small study found that a khorasan wheat based diet improved liver function and inflammation. However regardless of the diet, measures of oxidative stress, which assesses the imbalance of free radicals and antioxidants in the body, was significantly reduced and some individuals were shown to regress from moderate to mild NAFLD. Nutrition practitioners who have clients with mild-moderate NAFLD may recommend a khorasan wheat based diet in the short term to improve biochemical and inflammatory markers and to potentially reverse disease development.
Abstract
OBJECTIVE KAMUT khorasan is an ancient grain with widely acclaimed health benefits. The aim of this study was to investigate the effects of a replacement diet with ancient khorasan wheat products in patients with NAFLD, in comparison to a similar replacement diet with control products made from organic semi-whole-grain modern wheat. METHODS Forty NAFLD patients (12 M/28 F; age 55.2 ± 10.4 years) with mild to moderate liver steatosis were included. The experimental design was a randomized, double-blind, parallel-arm study with 20 participants assigned to consume either KAMUT khorasan or control wheat products (pasta, bread, crackers, biscuits) over a 3-month period. Anthropometric measurements, blood analyses, and ultrasonography examination were performed at both the beginning and end of each dietary intervention. RESULTS After the implementation of a general linear model for repeated measurements adjusted for baseline demographic details, risk factors, and medication, alanine aminotransferase (ALT) was significantly reduced by 12%, aspartate aminotransferase (AST) by 14%, alkaline phosphatase (ALP) by 8%, and cholesterol by 6% only in the khorasan group (p < 0.05 for all). Similarly, significant reductions in circulating proinflammatory tumor necrosis factor-alpha by 50%, interleukin l-receptor antagonist-alpha by 37%, interleukin-8 by 24%, and interferon gamma by 24% were evident only in participants who consumed the khorasan products (p < 0.05 for all). Finally, significant improvements in the liver steatosis grading, Doppler perfusion index values, and reactive oxygen species (ROS) production were evident after consumption of both the khorasan and control products. CONCLUSIONS This study suggests that a short-term replacement diet with ancient KAMUT khorasan products is most effective in reducing metabolic risk factors and ameliorating the liver profile in patients with NAFLD.
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High-Dose Vitamin D3 Administration Is Associated With Increases in Hemoglobin Concentrations in Mechanically Ventilated Critically Ill Adults: A Pilot Double-Blind, Randomized, Placebo-Controlled Trial.
Smith, EM, Jones, JL, Han, JE, Alvarez, JA, Sloan, JH, Konrad, RJ, Zughaier, SM, Martin, GS, Ziegler, TR, Tangpricha, V
JPEN. Journal of parenteral and enteral nutrition. 2018;42(1):87-94
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Anaemia is common in critically ill patients and is associated with increased mortality and potentially an extended need for a ventilator. Treatment for anaemia can be invasive and carries a level of risk; therefore further studies on complementary therapies are warranted. Vitamin D has the potential to decrease anaemia through decreasing the production of the iron-regulatory hormone hepcidin. The study aimed to test whether high dose vitamin D would affect haemoglobin concentrations in critically ill patients. In this pilot double-blind randomised control trial, 30 critically ill patients were assigned 250,000 IU vitamin D, 500,000 IU vitamin D or placebo split over 5 doses in 5 days. Blood was taken weekly for up to four weeks and analysed for vitamin D and hepcidin concentrations. Vitamin D concentrations increased significantly in both groups that received vitamin D, compared to no change in the placebo group. Compared to placebo, haemaglobin concentrations significantly increased by 8% in the group receiving 500,000 IU vitamin D but not in the lower dose group. After one week, hepcidin concentrations were significantly decreased in the 500,000 IU vitamin D group, however this was not sustained and no differences between either group and placebo were observed at the end of the study. This did not translate into a reduction in anaemia in either group at any point throughout the study. Extremely high dose vitamin D supplementation was shown to significantly increase circulating vitamin D concentrations and acutely reduce hepcidin. Although anaemia was not affected, clinicians could use this study as an example of safe usage of high dose vitamin D in critically ill patients to improve haemaglobin concentrations, which could reduce the need for invasive treatments, reduce hospital stay duration and treatment costs.
Abstract
BACKGROUND Anemia and vitamin D deficiency are highly prevalent in critical illness, and vitamin D status has been associated with hemoglobin concentrations in epidemiologic studies. We examined the effect of high-dose vitamin D therapy on hemoglobin and hepcidin concentrations in critically ill adults. MATERIALS AND METHODS Mechanically ventilated critically ill adults (N = 30) enrolled in a pilot double-blind, randomized, placebo-controlled trial of high-dose vitamin D3 (D3 ) were included in this analysis. Participants were randomized to receive placebo, 50,000 IU D3 , or 100,000 IU D3 daily for 5 days (totaling 250,000 IU D3 and 500,000 IU D3 , respectively). Blood was drawn weekly throughout hospitalization for up to 4 weeks. Linear mixed-effects models were used to assess change in hemoglobin and hepcidin concentrations by treatment group over time. RESULTS At enrollment, >75% of participants in all groups had plasma 25-hydroxyvitamin D (25(OH)D) concentrations <30 ng/mL, and >85% of participants across groups were anemic. In the 500,000-IU D3 group, hemoglobin concentrations increased significantly over time (Pgroup × time = .01) compared with placebo but did not change in the 250,000-IU D3 group (Pgroup × time = 0.59). Hepcidin concentrations decreased acutely in the 500,000-IU D3 group relative to placebo after 1 week (P = .007). Hepcidin did not change significantly in the 250,000-IU D3 group. CONCLUSION In these critically ill adults, treatment with 500,000 IU D3 was associated with increased hemoglobin concentrations over time and acutely reduced serum hepcidin concentrations. These findings suggest that high-dose vitamin D may improve iron metabolism in critical illness and should be confirmed in larger studies.
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Food Exclusion Based on IgG Antibodies Alleviates Symptoms in Ulcerative Colitis: A Prospective Study.
Jian, L, Anqi, H, Gang, L, Litian, W, Yanyan, X, Mengdi, W, Tong, L
Inflammatory bowel diseases. 2018;24(9):1918-1925
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Ulcerative Colitis (UC) is a chronic debilitating inflammatory bowel disease that may need lifetime management. Dietary management of UC by eliminating food antigens that may be causing a delayed immune response is one of the approaches used widely to manage the disease. Food intolerance, mediated by immunoglobulin G antibodies in response to food antigens that are otherwise harmless, could be one cause of UC. Low levels of digestive enzymes may result in poor digestion of glucose, amino acids, and glycerol, followed by an immune reaction that leads to food sensitivities. Ninety-seven UC patients were enrolled in this open-label, stratified, prospective, randomised controlled trial to evaluate the effect of an elimination diet versus a sham diet (a normal healthy diet). Following an IgG-specific exclusion diet for six months resulted in the alleviation of UC symptoms and an improvement in health-related quality of life. Further studies are needed to confirm the effectiveness of the exclusion diet since the intervention group did not show a significant reduction in IgG antibody levels. These results can be used by healthcare professionals to understand the potential role of exclusion diets in the management of UC.
Abstract
BACKGROUND Most patients with ulcerative colitis (UC) rely predominantly on medication for disease control. Diet interventions can reduce pharmaceutical expenditures and prolong remission. We designed a prospective study to evaluate whether an immunoglobulin G (IgG)-guided exclusion diet would improve symptoms and quality of life (QoL) in patients with UC. METHODS The 6-month diet intervention included 97 patients with UC, who were randomly divided into an intervention group (n = 49) and a control (n = 48) group. Individual diet plans were created for the intervention group according to IgG titers; the control group ate a healthy diet as normal. Observational indices included disease activity, extraintestinal manifestations, nutritional status, and QoL. Relationships between food-specific IgG antibodies and these indices were also analyzed. RESULTS At baseline, there were no significant differences between the groups. Food-specific IgG antibodies were detected in 70.10% of participants. After intervention, the Mayo score was significantly lower in the intervention group than in the control group (2.41 ± 0.89 vs 3.52 ± 1.15, P < 0.05). The number of patients with extraintestinal manifestations decreased from 7 to 2 in the intervention group and from 6 to 5 in the control group. As for nutritive indices, the intervention group had higher mean body mass index and albumin than the control group (23.88 ± 3.31 vs 21.50 ± 6.24 kg/m2, respectively, P < 0.05; 48.05 ± 6.39 vs 45.72 ± 5.48 g/L, respectively, P < 0.05), whereas prealbumin and transferrin were not significantly different between the groups. QoL improved after food exclusion (P < 0.05). CONCLUSIONS An IgG-guided exclusion diet ameliorated UC symptoms and improved QoL. Interactions between IgG-based food intolerance and UC warrant further study.