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A randomized, double blind, placebo controlled, multicenter clinical trial to assess the efficacy and safety of Emblica officinalis extract in patients with dyslipidemia.
Upadya, H, Prabhu, S, Prasad, A, Subramanian, D, Gupta, S, Goel, A
BMC complementary and alternative medicine. 2019;19(1):27
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Emblica officinalis (Amla or Indian gooseberry) is a fruit that has been traditionally used in Ayurvedic medicine. It has been shown to be effective in the management of dyslipidemia (abnormal fat metabolism), a risk factor for heart disease, in animal models and in pilot clinical studies without major side effects. This multicenter, randomised, placebo controlled, double blind clinical trial was designed to evaluate the efficacy and safety of a proprietary full spectrum amla extract (containing pulp and seeds) in patients with dyslipidemia. 98 patients were enrolled and all completed the 12 week study. None of them were taking any medication for their dyslipidaemia. All the patients enrolled in the study were also asked to initiate lifestyle changes (healthy diet with exercise at least 4 days a week). Apart from conventional lipid parameters, the investigators also measured a number of other parameters relevant to heart disease, including the atherogenic index of plasma (AIP, a marker of heart disease risk). Compared to the placebo group the amla group had significantly greater reductions in triglycerides, LDL-cholesterol, VLDL-cholesterol and the atherogenic index of plasma (AIP, a better predictor of heart disease risk). There were no significant changes in HDL-cholesterol, CoQ10 (lowering of CoQ10 is a concern with many cholesterol lowering drugs), homocysteine, thyroid stimulating hormone (TSH) or fasting blood glucose. Four non-serious adverse events were observed: mild headache, mild fever, two times gastritis (all resolved with standard treatment), three were in the placebo group, one in the amla group. There were no changes in routine blood tests and vital signs (blood pressure, heart rate, temperature, respiratory rate). The authors conclude that the amla extract has significant potential to improve dyslipidaemia without side effects commonly seen with cholesterol lowering drugs.
Abstract
BACKGROUND Dyslipidemia is one of the most frequently implicated risk factors for development of atherosclerosis. This study evaluated the efficacy of amla (Emblica officinalis) extract (composed of polyphenols, triterpenoids, oils etc. as found in the fresh wild amla fruit) in patients with dyslipidemia. METHODS A total of 98 dyslipidemic patients were enrolled and divided into amla and placebo groups. Amla extract (500 mg) or a matching placebo capsule was administered twice daily for 12 weeks to the respective group of patients. The patients were followed up for 12 weeks and efficacy of study medication was assessed by analyzing lipid profile. Other parameters evaluated were apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), Coenzyme Q10 (CoQ10), high-sensitive C-reactive protein (hsCRP), fasting blood sugar (FBS), homocysteine and thyroid stimulating hormone (TSH). RESULTS In 12 weeks, the major lipids such as total cholesterol (TC) (p = 0.0003), triglyceride (TG) (p = 0.0003), low density lipoprotein cholesterol (LDL-C) (p = 0.0064) and very low density lipoprotein cholesterol (VLDL-C) (p = 0.0001) were significantly lower in amla group as compared to placebo group. Additionally, a 39% reduction in atherogenic index of the plasma (AIP) (p = 0.0177) was also noted in amla group. The ratio of Apo B to Apo A1 was reduced more (p = 0.0866) in the amla group as compared to the placebo. There was no significant change in CoQ10 level of amla (p = 0.2942) or placebo groups (p = 0.6744). Although there was a general trend of FBS reduction, the numbers of participants who may be classified as pre-diabetes and diabetes groups (FBS > 100 mg/dl) in the amla group were only 8. These results show that the amla extract used in the study is potentially a hypoglycaemic as well. However, this needs reconfirmation in a larger study. CONCLUSIONS The Amla extract has shown significant potential in reducing TC and TG levels as well as lipid ratios, AIP and apoB/apo A-I in dyslipidemic persons and thus has scope to treat general as well as diabetic dyslipidemia. A single agent to reduce cholesterol as well as TG is rare. Cholesterol reduction is achieved without concomitant reduction of Co Q10, in contrast to what is observed with statins. TRIAL REGISTRATION Registered with Clinical Trials Registry- India at www.ctri.nic.in (Registration number: CTRI/2015/04/005682 ) on 8 April 2015 (retrospectively registered).
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Combined aerobic exercise and high-intensity respiratory muscle training in patients surgically treated for non-small cell lung cancer: a pilot randomized clinical trial.
Messaggi-Sartor, M, Marco, E, Martínez-Téllez, E, Rodriguez-Fuster, A, Palomares, C, Chiarella, S, Muniesa, JM, Orozco-Levi, M, Barreiro, E, Güell, MR
European journal of physical and rehabilitation medicine. 2019;55(1):113-122
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Lung cancer treatment initiates a deconditioning storm that further reduces the capacity to deliver and utilize oxygen and metabolic substrates during exercise, contributing to poor cardiorespiratory fitness. The main aim of this study was to assess the impact of aerobic exercise with inspiratory and expiratory muscle training on cardiovascular fitness and respiratory muscle dysfunction in non-small cell lung cancer patients. The study is a two-centre, prospective, single-blind, pilot randomized controlled trial. The eligible patients were randomly assigned to the exercise (n=16) or control groups (n=21). Study results showed strong improvement in respiratory muscle strength and exercise capacity following high-intensity inspiratory and expiratory muscle training. Authors conclude that structured and supervised exercise interventions should be recommended to patients with lung cancer.
Abstract
BACKGROUND Lung resection surgery further decreases exercise capacity and negatively affects respiratory muscle function in patients with non-small cell lung cancer (NSCLC). The best design for exercise interventions in these patients has not been determined yet. AIM: To assess the impact of aerobic exercise and high-intensity respiratory muscle training on patient outcomes following lung cancer resection surgery. DESIGN Prospective, single-blind, pilot randomized controlled trial. SETTING Outpatient cardiopulmonary rehabilitation unit of two university hospitals. POPULATION Thirty-seven patients with NSCLC after tumor resection. METHODS Patients were randomly assigned to exercise training or usual post-operative care. The training program consisted of aerobic exercises and high-intensity respiratory muscle training (24 supervised sessions, 3 per week, 8 weeks). Primary outcome was exercise capacity assessed with peak oxygen uptake (VO2peak) during cardiopulmonary exercise test. Secondary outcomes included changes in respiratory muscle strength, levels of serum insulin growth factor I (IGF-I) and IGF binding protein 3 (IGFBP-3), and quality of life assessed with the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) questionnaire. RESULTS The 8-week training program was associated with significant improvement in VO2peak (2.13 mL/Kg/min [95%CI 0.06 to 4.20]), maximal inspiratory and expiratory pressures (18.96 cmH2O [95% CI 2.7 to 24.1] and 18.58 cmH2O [95% CI 4.0 to 33.1], respectively) and IGFBP-3 (0.61 µg/mL [%95 CI 0.1 to 1.12]). No significant differences were observed in the EORTC QLQ-C30. CONCLUSIONS An 8-week exercise program consisting of aerobic exercise and high-intensity respiratory muscle training improved exercise capacity, respiratory muscle strength, and serum IGFBP-3 levels in NSCLC patients after lung resection. There was no impact on the other outcomes assessed. CLINICAL REHABILITATION IMPACT A combination of aerobic exercise and respiratory muscle training could be included in the rehabilitation program of deconditioned patients with NSCLC after lung resection surgery.
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Fermented Foods: Definitions and Characteristics, Impact on the Gut Microbiota and Effects on Gastrointestinal Health and Disease.
Dimidi, E, Cox, SR, Rossi, M, Whelan, K
Nutrients. 2019;11(8)
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Fermented foods have grown in popularity due to their proposed health benefits but there is limited clinical evidence for the effectiveness of most fermented foods in gastrointestinal health. This review paper looks at non-dairy fermented foods which have been studied in at least one RCT: kefir, sauerkraut, natto, and sourdough bread. The health benefits are attributed to the high ratio of probiotic microorganisms, metabolites, or ability to convert compounds into active metabolites, as well as prebiotics and vitamins contained in these foods. Kimchi has the greatest evidence from epidemiological and case control studies investigating risk of gastric cancers. Different food composition of kimchi is shown to both increase and decrease risks, whilst it had no impact on H. pylori levels. There were no studies on kefir in functional bowel disorders however, it was shown to help lactose malabsorption and reduce H. pylori levels. A small RCT on Sauerkraut showed it reduced IBS severity in patients and increased in vitro activity of key liver and kidney detoxifying enzymes. There are small pockets of data that show that tempeh may influence gut microbiota in humans, and that natto may increase bifidobacterial and short-chain fatty acids in healthy volunteers. There are numerous limited cohort studies on miso and cancer risk but no studies on gastrointestinal conditions. Finally, sourdough was shown to reduce FODMAPS and be better tolerated in IBS patients, reducing bloating, nausea and discomfort. Overall, all the studies provide insufficient evidence on fermented foods and gastrointestinal health.
Abstract
Fermented foods are defined as foods or beverages produced through controlled microbial growth, and the conversion of food components through enzymatic action. In recent years, fermented foods have undergone a surge in popularity, mainly due to their proposed health benefits. The aim of this review is to define and characterise common fermented foods (kefir, kombucha, sauerkraut, tempeh, natto, miso, kimchi, sourdough bread), their mechanisms of action (including impact on the microbiota), and the evidence for effects on gastrointestinal health and disease in humans. Putative mechanisms for the impact of fermented foods on health include the potential probiotic effect of their constituent microorganisms, the fermentation-derived production of bioactive peptides, biogenic amines, and conversion of phenolic compounds to biologically active compounds, as well as the reduction of anti-nutrients. Fermented foods that have been tested in at least one randomised controlled trial (RCT) for their gastrointestinal effects were kefir, sauerkraut, natto, and sourdough bread. Despite extensive in vitro studies, there are no RCTs investigating the impact of kombucha, miso, kimchi or tempeh in gastrointestinal health. The most widely investigated fermented food is kefir, with evidence from at least one RCT suggesting beneficial effects in both lactose malabsorption and Helicobacter pylori eradication. In summary, there is very limited clinical evidence for the effectiveness of most fermented foods in gastrointestinal health and disease. Given the convincing in vitro findings, clinical high-quality trials investigating the health benefits of fermented foods are warranted.
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Fluoride exposure and kidney and liver function among adolescents in the United States: NHANES, 2013-2016.
Malin, AJ, Lesseur, C, Busgang, SA, Curtin, P, Wright, RO, Sanders, AP
Environment international. 2019;132:105012
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Fluoride is added to the water supply in some parts of the UK, US and Canada to help prevent tooth decay, but there is some concern that long-term exposure to fluoride could be harmful to health. Animal studies have indicated that fluoride may cause kidney and liver damage. This US study aimed to evaluate whether greater fluoride exposure is associated with altered kidney and liver function in adolescents. This cross-sectional study looked at data collected from the National Health and Nutrition Examination Survey (2013-2016). The average age of adolescents was 15 years. Fluoride levels were measured in blood and in household tap water. Higher levels of fluoride in the blood were associated with a lower estimated glomerular filtration rate, a higher blood uric acid concentration, and a lower blood urea nitrogen concentration. Higher levels of fluoride in tap water were associated with a lower blood urea nitrogen concentration. The researchers concluded that fluoride exposure may contribute to complex changes in kidney and liver function in US adolescents. However, researchers could not rule out the possibility that an altered kidney or liver function may impact the body’s ability to absorb or metabolise fluoride.
Abstract
BACKGROUND Hepato- and nephrotoxicity of fluoride have been demonstrated in animals, but few studies have examined potential effects in humans. This population-based study examines the relationship between chronic low-level fluoride exposure and kidney and liver function among United States (U.S.) adolescents. This study aimed to evaluate whether greater fluoride exposure is associated with altered kidney and liver parameters among U.S. youth. METHODS This cross-sectional study utilized data from the National Health and Nutrition Examination Survey (2013-2016). We analyzed data from 1983 and 1742 adolescents who had plasma and water fluoride measures respectively and did not have kidney disease. Fluoride was measured in plasma and household tap water. Kidney parameters included estimated glomerular filtration rate (calculated by the original Schwartz formula), serum uric acid, and the urinary albumin to creatinine ratio. Liver parameters were assessed in serum and included alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, blood urea nitrogen, gamma-glutamyl transferase, and albumin. Survey-weighted linear regression examined relationships between fluoride exposure and kidney and liver parameters after covariate adjustment. A Holm-Bonferroni correction accounted for multiple comparisons. RESULTS The average age of adolescents was 15.4 years. Median water and plasma fluoride concentrations were 0.48 mg/L and 0.33 μmol/L respectively. A 1 μmol/L increase in plasma fluoride was associated with a 10.36 mL/min/1.73 m2 lower estimated glomerular filtration rate (95% CI: -17.50, -3.22; p = 0.05), a 0.29 mg/dL higher serum uric acid concentration (95% CI: 0.09, 0.50; p = 0.05), and a 1.29 mg/dL lower blood urea nitrogen concentration (95%CI: -1.87, -0.70; p < 0.001). A 1 mg/L increase in water fluoride was associated with a 0.93 mg/dL lower blood urea nitrogen concentration (95% CI: -1.44, -0.42; p = 0.007). CONCLUSIONS Fluoride exposure may contribute to complex changes in kidney and liver related parameters among U.S. adolescents. As the study is cross-sectional, reverse causality cannot be ruled out; therefore, altered kidney and/or liver function may impact bodily fluoride absorption and metabolic processes.
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Effect of Montmorency tart cherry juice on cognitive performance in older adults: a randomized controlled trial.
Chai, SC, Jerusik, J, Davis, K, Wright, RS, Zhang, Z
Food & function. 2019;10(7):4423-4431
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A previous study demonstrated that tart cherry juice can lower blood pressure and improve inflammation and oxidative stress, which are risk factors for dementia, in older adults. This study, by the same authors, explored whether tart cherry juice could improve memory and cognitive function. In this randomised controlled trial, 37 adults between the ages of 65-80 with normal cognitive function were given two cups of either Montmorency tart cherry juice or a control drink every day for 12 weeks. At the end of the study, those that consumed the tart cherry juice showed significant improvements in several of the measures of memory and cognitive function, including contentment with memory function and spatial working memory, compared to the control group. The authors concluded that daily tart cherry juice consumption may improve cognitive abilities, possibly through the antioxidant and anti-inflammatory properties of tart cherry and its ability to lower BP.
Abstract
Hypertension, inflammation and oxidative stress are important factors in the development of cognitive impairment. Our previous study demonstrated that tart cherry juice can lower systolic blood pressure (BP) and improve inflammatory and oxidative stress status in older adults. As part of our previous trial, we explored whether daily consumption of tart cherry juice would improve cognitive abilities. In this randomized controlled trial, 37 adults between the ages of 65-80 with normal cognitive function were recruited and randomly assigned to consume two cups of Montmorency tart cherry juice for 12 weeks. Subjective memory and objective cognitive performance were assessed at baseline and after the 12-week juice supplementation using a validated subjective memory questionnaire and a standardized battery of tests. Daily caloric intake and physical activity levels were assessed throughout the study period. After the intervention, participants in the tart cherry group had higher contentment with memory scores (mean difference of 2.7; 95% CI: 1.2 to 4.2; p = 0.02), lowered their scores of movement time (mean difference of -10.4; 95% CI: -13.4 to -7.5; p = 0.03) as well as performed better on the paired associates learning task (mean difference of -8.5; 95% CI: -12.5 to -4.5; p = 0.02) compared to the control group. The within-group analysis showed that the visual sustained attention (p < 0.0001) and spatial working memory (p = 0.06) improved after the 12-week consumption of tart cherry juice compared with corresponding baseline values. Daily tart cherry juice consumption may improve cognitive abilities. This may be through anti-oxidative and anti-inflammatory properties of tart cherry and its ability to lower BP. Further research is needed to confirm these findings.
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Lipid profile is associated with decreased fatigue in individuals with progressive multiple sclerosis following a diet-based intervention: Results from a pilot study.
Fellows Maxwell, K, Wahls, T, Browne, RW, Rubenstein, L, Bisht, B, Chenard, CA, Snetselaar, L, Weinstock-Guttman, B, Ramanathan, M
PloS one. 2019;14(6):e0218075
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Fatigue is a frequent and debilitating symptom of multiple sclerosis (MS) and is independent of level of disability. The authors previously reported that a 12 months diet and lifestyle intervention was effective at reducing fatigue in patients with progressive MS. The aims of this study were to characterise the changes in lipid and cholesterol biomarkers during the intervention, and to investigate whether these biomarkers were associated with fatigue outcomes. Data of 18 MS patients were analysed. The intervention consisted of a modified Paleolithic diet, supplemented with exercise, neuromuscular electrical stimulation (NMES) and stress reduction techniques (Wahl’s protocol). Fatigue was significantly decreased at 3, 6, 9 and 12 months compared to baseline, and more so in those having more of the recommended foods and less of the excluded foods. The exercise, NMES, and stress reduction components of the intervention were not associated with changes in fatigue. All variables of the lipid profiles improved during the 12 months intervention. These improvements were associated with the changes in nutrient intakes, in particular, with amounts and types of fat, carbohydrates and fibre. Changes in total and HDL cholesterol, but not LDL cholesterol or triglycerides were associated with a decrease in fatigue. The authors hypothesise that the benefits of the changes in lipid profile on fatigue may be mediated by the positive effects of HDL-cholesterol on mitochondrial function (mitochondria are the “power houses” of every cell, i.e. produce energy on the cellular level), in particular those in the muscles. Limitations of the study include the small sample size, lack of control group and randomisation. The authors conclude that diet-induced changes in HDL and total cholesterol may mediate the positive effects of a dietary and lifestyle intervention on fatigue in MS patients.
Abstract
PURPOSE To investigate associations between lipid profiles and fatigue in a cohort of progressive multiple sclerosis (MS) patients on a diet-based multimodal intervention. METHODS This pilot study included 18 progressive MS patients who participated in a prospective longitudinal study of fatigue following a diet-based multimodal intervention that included exercise, neuromuscular electrical stimulation and stress reduction. The diet recommended high intake of vegetables and fruits, encouraged consumption of animal and plant protein and excluded foods with gluten-containing grains, dairy and eggs. Fatigue was measured on the Fatigue Severity Scale (FSS) at baseline and every 3 months for 12 months. A lipid profile consisting of high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and triglycerides (TG) was obtained on fasting blood samples at baseline and 12 months. RESULTS FSS scores decreased from a baseline of 5.51 (95% CI: 4.86, 6.16) to a mean of 3.03 (95% CI: 2.23, 3.82) at 12 months (p < 0.001). At 12 months, increases in HDL-C (mean change: +6.0 mg/dl; 95% CI: 0.3, 12.0; p = 0.049) and decreases in BMI (mean change: -2.6 kg/m2; 95% CI: -3.6, -2.5; p < 0.001), LDL-C (mean change: -10.4 mg/dl; 95% CI:-19.7, -1.2; p = 0.029), TG (mean change: -29.2 mg/dl; 95% CI: -44.3, -14.2; p = 0.001), TG to HDL-C ratio (mean change: -0.6; 95% CI: -1.0, -0.3; p = 0.002) and TC to HDL-C ratio (mean change:-0.6; 95% CI: -1.0, -0.3; p = 0.003) were observed compared to baseline. Improvements in FSS were associated with increases in HDL-C (β = -0.05; 95% CI: -0.1, -0.0004; p = 0.048) and changes in TC (p = 0.005) from baseline to 12 months. CONCLUSIONS Lipid profile variables are associated with improvements in fatigue in progressive MS patients on a diet-based multimodal intervention.
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A Review of Dietary (Phyto)Nutrients for Glutathione Support.
Minich, DM, Brown, BI
Nutrients. 2019;11(9)
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Glutathione is made up of 3 amino acids (cysteine, glutamic acid and glycine) and plays important roles in the body, including oxidative stress reduction, supporting the immune system and contributing to detoxification processes. Evidence suggests that it is an important marker and target for treatment in many chronic, age-related diseases. This review article explores the evidence of nutritional strategies to improve glutathione status. The authors examine the evidence for supplementation of the precursors of glutathione as well as with various forms of supplemental glutathione itself, and the impacts on glutathione status and clinical impacts. Crucially, the review article provides information on dietary sources of precursors of glutathione and glutathione itself, which will provide Nutrition Practitioners with compelling information for use in clinic. Lean protein, brassica vegetables, polyphenol-rich fruits and vegetables, green tea, herbs and spices and omega-3 rich foods are all discussed in detail.
Abstract
Glutathione is a tripeptide that plays a pivotal role in critical physiological processes resulting in effects relevant to diverse disease pathophysiology such as maintenance of redox balance, reduction of oxidative stress, enhancement of metabolic detoxification, and regulation of immune system function. The diverse roles of glutathione in physiology are relevant to a considerable body of evidence suggesting that glutathione status may be an important biomarker and treatment target in various chronic, age-related diseases. Yet, proper personalized balance in the individual is key as well as a better understanding of antioxidants and redox balance. Optimizing glutathione levels has been proposed as a strategy for health promotion and disease prevention, although clear, causal relationships between glutathione status and disease risk or treatment remain to be clarified. Nonetheless, human clinical research suggests that nutritional interventions, including amino acids, vitamins, minerals, phytochemicals, and foods can have important effects on circulating glutathione which may translate to clinical benefit. Importantly, genetic variation is a modifier of glutathione status and influences response to nutritional factors that impact glutathione levels. This narrative review explores clinical evidence for nutritional strategies that could be used to improve glutathione status.
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Effectiveness of Vitamin D Supplementation in the Management of Multiple Sclerosis: A Systematic Review.
Berezowska, M, Coe, S, Dawes, H
International journal of molecular sciences. 2019;20(6)
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Epidemiological research shows that Vitamin D status is associated with reduced activity and progression of disease in multiple sclerosis (MS). This review assessed the evidence from ten double-blind randomised controlled trials, including a total of 627 adults with relapsing remitting MS (RRMS), for the clinical effectiveness of vitamin D supplementation compared to placebo in disease and symptom management. The results from the reviewed studies on disease progression and immunological blood parameters were mixed. Where benefits of vitamin D supplementation were seen this tended to be in those groups where vitamin D levels were low at the start of the study. Those studies evaluating the safety and tolerability of vitamin D reported no serious adverse events. The authors conclude that baseline serum vitamin D levels may be a predictor of improvements in RRMS with vitamin D supplementation, and that further research should include baseline vitamin D as part of the assessment.
Abstract
OBJECTIVE to examine the extent of effect vitamin D in Multiple Sclerosis (MS) on pathology and symptoms. METHODS A literature search was performed in November 2018 (CRD42018103615). Eligibility criteria: randomised control trials in English from 2012 to 2018; a clinical diagnosis of MS; interventions containing vitamin D supplementation (vitamin D3 or calcitriol) in disease activity compared to a control/placebo; improvement in: serum 25(OH)D, relapse rates, disability status by Expanded Disability Status Scale (EDSS) scores, cytokine profile, quality of life, mobility, T2 lesion load and new T2 or T1 Gd enhancing lesions, safety and adverse effects. Risk of bias was evaluated. RESULTS Ten studies were selected. The study size ranged from 40 to 94 people. All studies evaluated the use of vitamin D supplementation (ranging from 10 to 98,000 IU), comparing to a placebo or low dose vitamin D. The duration of the intervention ranged from 12 to 96 weeks. One trial found a significant effect on EDSS score, three demonstrated a significant change in serum cytokines level, one found benefits to current enhancing lesions and three studies evaluating the safety and tolerability of vitamin D reported no serious adverse events. Disease measures improved to a greater extent overall in those with lower baseline serum 25(OH)D levels. CONCLUSIONS As shown in 3 out of 10 studies, improvement in disease measures may be more apparent in those with lower baseline vitamin D levels.
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The Effect of Vitamin B12 and Folic Acid Supplementation on Serum Homocysteine, Anemia Status and Quality of Life of Patients with Multiple Sclerosis.
Nozari, E, Ghavamzadeh, S, Razazian, N
Clinical nutrition research. 2019;8(1):36-45
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Multiple sclerosis (MS) is a relatively common chronic neurological disorder in which damage to the protective covering of neurons occurs in different areas of the central nervous system. Relapsing remitting multiple sclerosis (RRMS) is the relapsing episodes of MS and periods of stability in between relapses. The aim of this study was to determine the effect of vitamin B12 and folic acid supplementation on serum homocysteine (amino acid), anaemia status and quality of life of RRMS patients The study is a double-blind clinical trial which recruited 50 participants. The participants were randomly assigned to one of the 2 groups of RRMS: the vitamin group or the placebo group. Results indicate that increasing the consumption of folic acid and vitamin B12 improved physical and mental dimensions of quality of life in the vitamin group. However, in the placebo group, improvements were only limited to the psychological dimension of quality of life and no significant change in the physical dimension was observed. Authors conclude that homocysteine levels, anaemia status, and eventually quality of life of patients with MS can be significantly improved by administration of 1mg of vitamin B12 monthly and adding rich-food sources of folic acid on their diet.
Abstract
Plasma homocysteine level and megaloblastic anemia status are two factors that can affect the quality of life of patients with multiple sclerosis (MS). We conducted this study to determine the effect of vitamin B12 and folic acid supplementation on serum homocysteine, megaloblastic anemia status and quality of life of patients with MS. A total of 50 patients with relapsing remitting multiple sclerosis (RRMS) included in this study which divided into 2 groups. The vitamin group received 5 mg folic acid tablet daily and 3 doses of vitamin B12 (1,000 mcg) injection and the other group received placebo and normal saline injection (same doses). The quality of life was measured by using Multiple Sclerosis Quality of Life-54 questionnaire (MSQOL-54). Fully automated fluorescence polarization immunoassay was used to measure serum homocysteine, vitamin B12 and folate. Complete blood count blood test was conducted to determine the anemia status. The mean homocysteine level reduced by 2.49 ± 0.39 µmol/L (p = 0.001), hemoglobin increased from 11.24 ± 1.54 to 13.12 ± 1.05 g/dL (p = 0.001), and mean corpuscular volume decreased from 95.50 ± 6.65 to 89.64 ± 4.24 in the vitamin group (p = 0.001). There was a significant improvement in the mental field of life quality in the placebo group (37.46 ± 19.01 to 50.98 ± 21.64; p = 0.001), whereas both physical and mental fields of quality of life were improved significantly in the vitamin group (40.38 ± 15.07 to 59.21 ± 12.32 and 29.58 ± 15.99 to 51.68 ± 18.22, respectively; p = 0.001). Serum homocysteine level decrease and anemia status improvement with vitamin B12 and folic acid supplementation reveal the potential role of these two vitamins in improving the life quality of MS patients. TRIAL REGISTRATION Iranian Registry of Clinical Trials Identifier: IRCT2015100313678N7.
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Vitamin D Supplementation in Central Nervous System Demyelinating Disease-Enough Is Enough.
Häusler, D, Weber, MS
International journal of molecular sciences. 2019;20(1)
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Vitamin D is associated with a reduced risk and severity of multiple sclerosis (MS). However, whether supplementing vitamin D level alters disease severity, is a matter of ongoing debate. This review looks at both clinical and pre-clinical evidence for supplementing vitamin D in people with MS. In vitro experiments show that vitamin D and its metabolites can alter function of various immune cells, mostly via interaction with vitamin D receptors (VDR). Results from human clinical trials, however, are mixed. Preclinical evidence suggests that high dose vitamin D supplementation, when leading to hypercalcaemia, a potentially serious side effect of excessive vitamin D intake, may worsen MS. The authors also review research which suggests mechanisms by which sun exposure can improve MS symptoms independent of vitamin D production. The authors conclude that moderate sun exposure, combined with adequate dietary intake of vitamin D, and in conjunction with a regular assessment of vitamin D serum levels (to avoid hypercalcaemia), might be the best strategy for patients with MS.
Abstract
The exact cause of multiple sclerosis (MS) remains elusive. Various factors, however, have been identified that increase an individual's risk of developing this central nervous system (CNS) demyelinating disease and are associated with an acceleration in disease severity. Besides genetic determinants, environmental factors are now established that influence MS, which is of enormous interest, as some of these contributing factors are relatively easy to change. In this regard, a low vitamin D status is associated with an elevated relapse frequency and worsened disease course in patients with MS. The most important question, however, is whether this association is causal or related. That supplementing vitamin D in MS is of direct therapeutic benefit, is still a matter of debate. In this manuscript, we first review the potentially immune modulating mechanisms of vitamin D, followed by a summary of current and ongoing clinical trials intended to assess whether vitamin D supplementation positively influences the outcome of MS. Furthermore, we provide emerging evidence that excessive vitamin D treatment via the T cell-stimulating effect of secondary hypercalcemia, could have negative effects in CNS demyelinating disease. This jointly merges into the balancing concept of a therapeutic window of vitamin D in MS.