Medical cannabis for pain management in patients undergoing chronic hemodialysis: randomized, double-blind, cross-over, feasibility study.

Background: Chronic pain is prevalent but difficult to treat in patients undergoing hemodialysis (HD). Effective and safe analgesics are limited in this patient population. Our aim in this feasibility study was to evaluate the safety of sublingual oil based medical cannabis for pain management in patients undergoing HD. Methods: In a prospective randomized, double-blind, cross-over design, patients undergoing HD with chronic pain were assigned to one of three arms: BOL-DP-o-04-WPE whole-plant extract (WPE), BOL-DP-o-04 cannabinoid extraction (API) or placebo. WPE and API contained trans-delta-9- tetrahydrocannabinol (THC) and cannabidiol (CBD) in a 1:6 ratio (1:6, THC:CBD). Patients were treated for 8 weeks, with subsequent 2-week wash out, followed by a cross-over to a different arm. The primary endpoint was safety. Results: Eighteen patients were recruited and 15 were randomized. Three did not complete drug titration period due to adverse events (AEs) and one patient died during titration due to sepsis (WPE). Of those who completed at least one treatment period, seven patients were in the WPE arm, five in the API and nine receiving placebo. The most common AEs were sleepiness, which improved after dose reduction or patient adaptation. Most AEs were mild to moderate and resolved spontaneously. Serious AEs considered related to study drug included one episode of accidental overdose (WPE) leading to hallucinations. Liver enzymes were stable during cannabis treatment. Conclusions: Short-term medical cannabis use in patients treated with HD was generally well tolerated. The safety data supports further studies to assess the overall risk-benefit of a treatment paradigm utilizing medical cannabis to control pain in this patient population.

Body Composition, Resting Energy Expenditure, and Metabolic Changes in Women Diagnosed with Differentiated Thyroid Carcinoma.

Background: Thyroid hormones heavily impact energy expenditure, body mass, and body composition. Their role in the state of exogenous subclinical hyperthyroidism in differentiated thyroid carcinoma (DTC) patients, however, is less well defined. The first aim of this study was to assess changes in body weight, body composition, resting energy expenditure (REE), respiratory quotient (RQ), and metabolic parameters in female DTC patients, starting from the phase of a euthyroid state before total thyroidectomy through the subsequent year after thyrotropin (TSH) suppression. The second aim was to assess the relationship between these variables and thyroid function parameters. Methods: This observational case series analyzed changes in body composition, calorimetric, and metabolic parameters of 15 DTC female patients at 5 time points: (1) at initial DTC diagnosis (euthyroid state), (2) at 2-3 weeks after thyroidectomy (hypothyroid state), (3) at 2-3 months of levothyroxine (LT4) treatment (exogenous euthyroid state), (4) after 6-9 months, and (5) after 1 year of TSH suppressive LT4 therapy (exogenous subclinical hyperthyroid state). A generalized estimating equation (GEE) analysis was performed to estimate the longitudinal correlations of the total triiodothyronine (TT3)/free thyroxine (fT4) ratio (as an independent variable) with body composition, metabolic, and calorimetric parameter changes (as dependent variables). Results: REE, REE per kilogram of lean body mass (REE/LBM), pulse, and systolic and diastolic blood pressure were significantly higher after TSH suppressive LT4 therapy. The GEE analysis revealed longitudinal negative correlations between the TT3/fT4 ratio and systolic blood pressure, fasting blood glucose, body mass index, android (abdominal wall and visceral mesentery) fat distribution, trunk, and arm fat distribution, REE, and REE/LBM. There was a positive correlation with RQ. Conclusions: REE, REE/LBM, pulse, and systolic and diastolic blood pressure were significantly higher after thyroidectomy, radioiodine and TSH suppressive therapy in female DTC patients, while no changes were observed in body weight or body composition. A lower TT3/fT4 ratio longitudinally correlated with increases in REE, REE/LBM, abdominal fat distribution, systolic blood pressure, and fasting blood glucose, as well as with decreased RQ. These findings highlight the importance of judicial balancing of the benefits and detriments of TSH suppression with subsequent decreased TT3/fT4 ratios for female DTC patients.

Vertical ground reaction force during standing and walking: Are they related to bone mineral density left-right asymmetries?

Osteoporosis is a systemic skeletal disease that is characterized by reduced bone mass, deterioration of bone tissue and skeletal fragility. The purpose of the current study was to determine whether asymmetrical femur bone mineral density (BMD) is associated with asymmetrical gait and standing. We compared measures of gait and standing asymmetry in subjects with (n=38) and without (n=11) significant left-right differences in BMD. Participants walked for 72m at their comfortable speed and stood quietly for 60s while outfitted with pressure-sensitive insoles. Based on the pressure measurements, indices of standing and gait asymmetry were determined. Gait Asymmetry (GA) indices of maximum ground reaction force (GRF) and stance time were significantly higher in the asymmetrical BMD group, compared to the symmetrical group (p<0.03). During quiet standing, maximal GRF was twice as high in those with BMD asymmetry, compared to those without, although this difference was not statistically significant (p=0.10). These preliminary findings indicate that femur BMD asymmetry and gait asymmetry are interrelated in otherwise healthy adults. Nutrition, metabolism and lifestyle are known contributors to BMD; typically, they affect bone health symmetrically. We suggest, therefore, that the BMD asymmetry may be due to previous changes in the loading pattern during walking that might have led to asymmetric bone deterioration. Future larger scale and prospective studies are needed to identify the mechanisms underlying the relationship between standing, gait and BMD and to explore whether gait training and exercises that target gait symmetry might help to reduce BMD asymmetry.

Changes in cerebral metabolism during ketogenic diet in patients with primary brain tumors: 1H-MRS study.

Normal brain cells depend on glucose metabolism, yet they have the flexibility to switch to the usage of ketone bodies during caloric restriction. In contrast, tumor cells lack genomic and metabolic flexibility and are largely dependent on glucose. Ketogenic-diet (KD) was suggested as a therapeutic option for malignant brain cancer. This study aimed to detect metabolic brain changes in patients with malignant brain gliomas on KD using proton magnetic-resonance-spectroscopy (1H-MRS). Fifty MR scans were performed longitudinally in nine patients: four patients with recurrent glioblastoma (GB) treated with KD in addition to bevacizumab; one patient with gliomatosis-cerebri treated with KD only; and four patients with recurrent GB who did not receive KD. MR scans included conventional imaging and 1H-MRS acquired from normal appearing-white-matter (NAWM) and lesion. High adherence to KD was obtained only in two patients, based on high urine ketones; in these two patients ketone bodies, Acetone and Acetoacetate were detected in four MR spectra-three within the NAWM and one in the lesion area -4 and 25 months following initiation of the diet. No ketone-bodies were detected in the control group. In one patient with gliomatosis-cerebri, who adhered to the diet for 3 years and showed stable disease, an increase in glutamin + glutamate and reduction in N-Acetyl-Aspartate and myo-inositol were detected during KD. 1H-MRS was able to detect ketone-bodies in patients with brain tumors who adhered to KD. Yet it remains unclear whether accumulation of ketone bodies is due to increased brain uptake or decreased utilization of ketone bodies within the brain.

Daily consumption of red grape cell powder in a dietary dose improves cardiovascular parameters: a double blind, placebo-controlled, randomized study.

Consumption of polyphenol-rich food and food ingredient such as grape and grape products improved various cardiovascular parameters. In this study, we investigate the effect of dietary daily consumption of red grape cell powder (RGC) on blood pressure (BP) and flow-mediated dilatation (FMD) as well as on oxidative stress in 50 subjects with prehypertension and mild hypertension. The subjects were randomized into groups that consumed 200, 400 mg RGC or placebo daily for 12 weeks. RGC consumption was associated with an improvement of FMD (p = 0.013). There was a significant decrease in lipid peroxidation (p = 0.013) after 12 weeks in a combined RGC-treated group. The diastolic BP decreased significantly in the 200 mg RGC group compared to the placebo group (p = 0.032). Our results indicate that a daily supplementation, of red grape cell powder, for 12 weeks affects endothelial function, diastolic BP and oxidative stress without any adverse effects.

Increased calcium absorption from synthetic stable amorphous calcium carbonate: double-blind randomized crossover clinical trial in postmenopausal women.

Calcium supplementation is a widely recognized strategy for achieving adequate calcium intake. We designed this blinded, randomized, crossover interventional trial to compare the bioavailability of a new stable synthetic amorphous calcium carbonate (ACC) with that of crystalline calcium carbonate (CCC) using the dual stable isotope technique. The study was conducted in the Unit of Clinical Nutrition, Tel Aviv Sourasky Medical Center, Israel. The study population included 15 early postmenopausal women aged 54.9 ± 2.8 (mean ± SD) years with no history of major medical illness or metabolic bone disorder, excess calcium intake, or vitamin D deficiency. Standardized breakfast was followed by randomly provided CCC or ACC capsules containing 192 mg elemental calcium labeled with 44Ca at intervals of at least 3 weeks. After swallowing the capsules, intravenous CaCl2 labeled with 42Ca on was administered on each occasion. Fractional calcium absorption (FCA) of ACC and CCC was calculated from the 24-hour urine collection following calcium administration. The results indicated that FCA of ACC was doubled (± 0.96 SD) on average compared to that of CCC (p < 0.02). The higher absorption of the synthetic stable ACC may serve as a more efficacious way of calcium supplementation.

Diet of patients after pouch surgery may affect pouch inflammation.

AIM: To investigate the diet of pouch patients compared to healthy controls, and to correlate pouch patients' diet with disease behavior. METHODS: Pouch patients were recruited and prospectively followed-up at the Comprehensive Pouch Clinic at the Tel Aviv Sourasky Medical Center. Pouch behavior was determined based on clinical, endoscopic and histological criteria. Healthy age- and sex-matched volunteers were selected from the "MABAT" Israeli Nutrition and Public Health Governmental Study and served as the control group. All the participants completed a 106-item food frequency questionnaire categorized into food groups and nutritional values based on those used in the United States Department of Agriculture food pyramid and the Israeli food pyramid. Data on Dietary behavior, food avoidance, the use of nutritional supplements, physical activity, smoking habits, and body-mass index (BMI) were also obtained. Pouch patients who had familial adenomatous polyposis (n = 3), irritable pouch syndrome (n = 4), or patients whose pouch surgery took place less than one year previously (n = 5) were excluded from analysis. RESULTS: The pouch patients (n = 80) consumed significantly more from the bakery products food group (1.2 ± 1.4 servings/d vs 0.6 ± 1.1 servings/d, P < 0.05) and as twice as many servings from the oils and fats (4.8 ± 3.4 servings/d vs 2.4 ± 2 servings/d, P < 0.05), and the nuts and seeds food group (0.3 ± 0.6 servings/d vs 0.1 ± 0.4 servings/d, P < 0.05) compared to the controls (n = 80). The pouch patients consumed significantly more total fat (97.6 ± 40.5 g/d vs 84.4 ± 39 g/d, P < 0.05) and fat components [monounsaturated fatty acids (38.4 ± 16.4 g/d vs 30 ± 14 g/d, P < 0.001), and saturated fatty acids (30 ± 15.5 g/d vs 28 ± 14.1 g/d, P < 0.00)] than the controls. In contrast, the pouch patients consumed significantly fewer carbohydrates (305.5 ± 141.4 g/d vs 369 ± 215.2 g/d, P = 0.03), sugars (124 ± 76.2 g/d vs 157.5 ± 90.4 g/d, P = 0.01), theobromine (77.8 ± 100 mg/d vs 236.6 ± 244.5 mg/d, P < 0.00), retinol (474.4 ± 337.1 µg/d vs 832.4 ± 609.6 µg/d, P < 0.001) and dietary fibers (26.2 ± 15.4 g/d vs 30.7 ± 14 g/d, P = 0.05) than the controls. Comparisons of the food consumption of the patients without (n = 23) and with pouchitis (n = 45) showed that the former consumed twice as many fruit servings as the latter (3.6 ± 4.1 servings/d vs 1.8 ± 1.7 servings/d, respectively, P < 0.05). In addition, the pouchitis patients consumed significantly fewer liposoluble antioxidants, such as cryptoxanthin (399 ± 485 µg/d vs 890.1 ± 1296.8 µg/d, P < 0.05) and lycopene (6533.1 ± 6065.7 µg/d vs 10725.7 ± 10065.9 µg/d, P < 0.05), and less vitamin A (893.3 ± 516 µg/d vs 1237.5 ± 728 µg/d, P < 0.05) and vitamin C (153.3 ± 130 mg/d vs 285.3 ± 326.3 mg/d, P < 0.05) than the patients without pouchitis. The mean BMI of the pouchitis patients was significantly lower than the BMI of the patients with a normal pouch: 22.6 ± 3.2 vs 27 ± 4.9 (P < 0.001). CONCLUSION: Decreased consumption of antioxidants by patients with pouchitis may expose them to the effects of inflammatory and oxidative stress and contribute to the development of pouchitis.

Outcome of percutaneous endoscopic gastrostomy insertion in patients with amyotrophic lateral sclerosis in relation to respiratory dysfunction.

Our objective was to describe a group of ALS patients who underwent percutaneous endoscopic gastrostomy (PEG) insertion, with emphasis on the respiratory function, by comparing patients with forced vital capacity (FVC) > 30% versus FVC ≤ 30%, and the effect of respiratory dysfunction on the perioperative complication rate and survival. Thirty consecutive ALS patients in whom FVC status was known underwent PEG insertion at our centre. Twenty of them had FVC > 30% (50.1% ± 20) at the time of the procedure, and 10 had FVC ≤ 30% (20.1% ± 7). Demographic and clinical data were reviewed in each patient. Results showed that all patients had successful PEG insertion without any complications. There was no statistically significant difference between the two FVC groups regarding survival after the date of PEG insertion. In conclusion, in this relatively small patient sample there was no difference in complication rate and survival after PEG insertion between patients with poor respiratory function (FVC ≤ 30%) at the time of the procedure and patients with better respiratory function (FVC > 30%). Therefore, according to our data, PEG insertion may be regarded as safe even in patients with low FVC and should be offered even to patients with respiratory dysfunction.

The relationship of depression, anxiety and stress with low bone mineral density in post-menopausal women.

UNLABELLED: The goal of the present study was to examine the relationships of depression, anxiety and stress with bone mineral density (BMD). We hypothesized negative relations between those mood variables and BMD in three assessed areas. The study showed association between depression and decreased BMD. The hypothesis regarding anxiety and stress was partially confirmed. INTRODUCTION: In the last decade, the relationship of osteoporosis to psychological variables has been increasingly studied. The accumulating evidence from these studies supports the conclusion that depression is related to decreased BMD. Nevertheless, several studies found no support for this relationship. Moreover, only a small number of studies examined the association between anxiety or stress and decreased BMD. The goal of the present study was to examine the relationships of depression, anxiety and stress with BMD by means of adequate measuring instruments, while controlling for background factors known to be related to BMD decrease (e.g., body mass index, family history). METHOD: The study included 135 post-menopausal female participants, who arrived for BMD screening, between the years 2006 and 2009. Several days prior to the examination, participants completed a series of questionnaires assessing depression and anxiety. BMD was measured using DXA, in spine, right and left hip. RESULTS: The study showed negative associations between depression and BMD variables in the three assessed areas. There were negative correlations between anxiety, stress and spine BMD, as well as a tendency towards negative relations in the right and left hip BMD. Concurrent hierarchical regressions showed that the addition of the three psychological variables increased the explained variance by 6­8 %. In addition, depression was found to have a unique significant contribution to the explained variance in right and left hip BMD. CONCLUSIONS: The findings provide supporting evidence for the existence of associations between mood variables and decreased BMD. Further research is required for gaining deeper insight into these relationships.

Effect of levan supplement in orange juice on weight, gastrointestinal symptoms and metabolic profile of healthy subjects: results of an 8-week clinical trial.

Levan is a commonly used dietary fiber of the fructans group. Its impact on health remains undetermined. This double blind controlled study aimed to investigate the effect of 8 weeks' daily consumption of 500 mL of natural orange juice enriched with 11.25 g of levan compared to the same amount of natural orange juice without levan on weight, gastrointestinal symptoms and metabolic profiles of 48 healthy volunteers. The statistical analyses compared between- and within-group findings at baseline, 4 weeks and study closure. The compared parameters were: weight, blood pressure, blood laboratory tests, daily number of defecations, scores of stool consistency, abdominal pain, bloating, gas, dyspepsia, vomiting and heartburn. Despite a higher fiber level recorded in the study group, there was no significant difference in the effect of the two kinds of juices on the studied parameters. Both juices decreased systolic and diastolic pressures, increased sodium level (within normal range), stool number, and bloating scores, and decreased gas scores. In conclusion, levan itself had no effect on weight, gastrointestinal symptoms or metabolic profile of healthy volunteers. Its possible effect on obese, hypertensive or hyperlipidemic patients should be investigated in further studies.

Effect of tumor load on energy expenditure in patients with pancreatic cancer.

OBJECTIVE: Increased metabolic rate may play a role in cancer cachexia, especially when caloric intake is significantly reduced. We studied the effect of tumor load on resting energy expenditure (REE) in patients with pancreatic cancer after normalizing for their daily caloric intake and body composition. METHODS: The cross-sectional study included 45 patients with pancreatic cancer (15 postoperation) and 75 controls. Resting energy expenditure was measured by indirect calorimetry, body composition was measured by dual-energy x-ray absorptiometry, and energy intake was measured by 3-day food records. RESULTS: There were no differences between pancreatic cancer patients who underwent surgery and those who did not in any of the anthropometric or metabolic parameters tested. Body mass index, lean body mass, body fat percentage, and energy intake were significantly lower in patients with pancreatic cancer (P < 0.0001) compared with healthy controls. Resting energy expenditure and the respiratory quotient were significantly lower in patients (P < 0.0001 and P < 0.025, respectively). There were no differences in REE between patients and controls when normalized by lean body mass. Respiratory quotients were significantly lower in patients who underwent surgery and in those who did not compared with controls. CONCLUSIONS: Pancreatic cancer does not increase REE above the normal levels nor does tumor burden contribute to increasing REE. Decreased daily energy intake of our patients may have reduced measured REE.

Breakfast improves cognitive function in cirrhotic patients with cognitive impairment.

BACKGROUND: Cognitive disturbances are relatively common in patients with liver disease. High protein load precipitates hepatic encephalopathy in cirrhotic patients. Minimal hepatic encephalopathy (MHE) is a prevalent neurocognitive complication of cirrhosis. OBJECTIVE: Because the influence of nutritional factors on the progression of cognitive impairment has not been explored in depth, this study aimed to investigate the effect on cognition of acute metabolic changes induced by breakfast consumption. DESIGN: Twenty-one subjects (10 women) with Child A cirrhosis and 21 age- and sex-matched healthy controls were enrolled. Patients and controls were divided into 2 groups: those receiving a breakfast of 500 kcal and 21 g protein and those receiving no breakfast. Serum ammonia concentrations and cognitive functions were studied (Mindstreams; NeuroTrax, Fresh Meadows, NY) before and 2 h after breakfast. A mixed model was used to analyze the data. RESULTS: At baseline, cirrhotic patients had significantly lower total scores and significantly lower subscores (P < 0.015 global cognitive score) in 4 of 7 cognitive categories, which is indicative of MHE. Patients with hyperammonemia (>85 mug/dL) scored significantly lower for attention than did patients with normal serum ammonia concentrations (P < 0.003). After 2 h, MHE patients and controls responded differently to breakfast consumption with regard to attention and executive functions (P < 0.003 and P < 0.04, respectively). Although patients' scores improved after breakfast consumption, despite an increase in serum ammonia, healthy controls who continued to fast performed better. CONCLUSIONS: Chronic hyperammonemia may negatively affect attention. Eating breakfast improves attention and executive functions of patients with MHE. Prolonged periods of starvation may be partly responsible for these changes. This trial was registered at clinicaltrials.gov as NCT01083446.

Short-term effect of prebiotics administration on stool characteristics and serum cytokines dynamics in very young children with acute diarrhea.

We investigated the effect of a mixture of long-chain fructo-oligosaccharides, galacto-oligosaccharides and acidic oligosaccharides on the number and consistency of stools and on immune system biomarkers in 104 supplemented and non-supplemented subjects (aged 9-24 months) with acute diarrhea. Interleukin-1 (IL-1), IL-1RA, IL-6, IL-8, IL-10, TNF-α and sIL-2R cytokine levels were determined. The significant decrease in number of stools and increase in stool consistency in the supplemented group was of little clinical relevance. The only significant change in pro- and anti-inflammatory cytokines was decreased TNF-α levels in the supplemented group. Prebiotic supplementation during acute diarrhea episodes did not influence the clinical course.

Tube feeding with a diabetes-specific feed for 12 weeks improves glycaemic control in type 2 diabetes patients.

BACKGROUND AND AIMS: Assess longer-term (12 weeks) effects of a diabetes-specific feed on postprandial glucose response, glycaemic control (HbA1c), lipid profile, (pre)-albumin, clinical course and tolerance in diabetic patients. METHODS: In this randomized, controlled, double-blind, parallel group study 25 type 2 diabetic patients on tube feeding were included. Patients received a soy-protein based, multi-fibre diabetes-specific feed or isocaloric, fibre-containing standard feed for 12 weeks, while continuing on their anti-diabetic medication. At the beginning, after 6 and 12 weeks, several (glycaemic) parameters were assessed. RESULTS: The postprandial glucose response (iAUC) to the diabetes-specific feed was lower at the 1st assessment compared with the standard feed (p=0.008) and this difference did not change over time. HbA1c decreased over time in the diabetes-specific and not in the standard feed group (treatment*time:p=0.034): 6.9+/-0.3% (mean+/-SEM) at baseline vs. 6.2+/-0.4% at 12 weeks in the diabetes-specific group compared to 7.9+/-0.3% to 8.7+/-0.4% in the standard feed group. No significant treatment*time effect was found for fasting glucose, insulin, (pre-) albumin or lipid profile, except for increase of HDL in the diabetes-specific group. CONCLUSIONS: The diabetes-specific feed studied significantly improved longer-term glycaemic control in diabetic patients. This was achieved in addition to on-going anti-diabetic medication and may affect clinical outcome.

n-3 phosphatidylserine attenuated scopolamine-induced amnesia in middle-aged rats.

Phosphatidylserine (PS) extracted from bovine brain differs from transphosphatidylated soybean lecithin PS (SB-PS) in its n-3 long-chain polyunsaturated fatty acid (LC-PUFA) content. Both, however, were suggested to affect cognitive performance. We compared the effect of chronic administration of a novel n-3 LC-PUFA PS conjugates (n-3 PS) versus SB-PS, fish oil (FO), SB-PS+FO, or control oil in middle-aged rats, on brain fatty acids composition and performance in behavioral tasks. Our hypothesis was that the n-3 LC-PUFA vehicles will affect these outcomes better than the other diets. Brain phospholipid docosahexaenoic acid levels increased significantly (p=0.0434) with n-3 PS only. None of the treatments affected the animals' task performance in compare with the control, although reversal from the non-match-to-sample to match-to-sample rule in the T-maze differed (p=0.0434) between the experimental diets. Conversely, the acquisition of the Morris water maze task was impaired by scopolamine (SCO) in all but the n-3 PS group (p=0.0019). In the probe, when pretreated with SCO, the SB-PS+FO group and to a lesser degree the n-3 PS group, spent longer latency times (p=0.0390) in the non-peripheral zones of the water maze compared to the control; this may be interpreted as anxiolytic-like behavior. These results suggest that the n-3 LC-PUFA carrier may play a role in these fatty acids bioavailability and their impact on specific cognitive processes.

Post-pyloric feeding.

Postpyloric feeding is an important and promising alternative to parenteral nutrition. The indications for this kind of feeding are increasing and include a variety of clinical conditions, such as gastroparesis, acute pancreatitis, gastric outlet stenosis, hyperemesis (including gravida), recurrent aspiration, tracheoesophageal fistula and stenosis in gastroenterostomy. This review discusses the differences between pre- and postpyloric feeding, indications and contraindications, advantages and disadvantages, and provides an overview of the techniques of placement of various postpyloric devices.

Do patients with amyotrophic lateral sclerosis (ALS) have increased energy needs?

BACKGROUND AND AIMS: Nutritional status is a prognostic factor for survival in amyotrophic lateral sclerosis (ALS) patients. We investigated the contribution of some of the components contributing to resting energy expenditure (REE) in order to determine whether potentially higher energy needs should be considered for these patients. METHODS: Thirty three ALS patients and 33 age- and gender-matched healthy controls participated. REE was measured by an open-circuit indirect calorimeter, body composition by dual energy X-ray absorptiometry, and estimated caloric intake by 7-day food records. RESULTS: Patients had lower body mass indices and lower lean body mass (LBM) than healthy controls. REE values (as a percentage of predicted) was similar but increased when normalized by LBM (P<0.001). LBM and REE decreased while REE/LBM increased in ten patients who were reassessed 6 months later. A model for predicting measured REE was constructed based on the different components, with 86% prediction of its variability. CONCLUSIONS: ALS is associated with increased REE. Various factors, such as poor caloric intake and mechanical ventilation, may mask this tendency. All the above parameters need to be considered during nutritional intervention to prevent additional muscle loss.

Ketogenic diet treatment in adults with refractory epilepsy: a prospective pilot study.

PURPOSE: To assess the efficacy of ketogenic diet (KD) in adults with refractory epilepsy. METHODS: Eligible subjects were 18-45 years old with at least two monthly focal seizures (with or without secondary generalization) documented by 8 weeks' follow-up. Classic form of KD treatment (90% fat) was planned for 12 weeks: daily seizure diaries were kept and measurements of the urinary ketones were recorded. Blood studies were done monthly and resting energy expenditure (REE), substrate utilization; body composition and quality of life (QOL) were measured before and after intervention. RESULTS: Nine patients were enrolled (average age 28+/-6 years; seven women). Only two subjects concluded the study per protocol due to an early drop-out. The average length of KD treatment was 8+/-4 weeks (two patients completed 12 weeks of KD; feelings of hunger and lack of efficacy resulted in withdrawal of the rest). The two patients who concluded the study had a more than 50% reduction in the frequency of the seizures. The others experienced no improvement. Adherence to the KD protocol (100%) was documented by constant ketonuria and increased fat utilization as indicated by the change in respiratory quotient (p<0.031). The KD increased the cholesterol levels (mainly LDL; p=0.0001). CONCLUSIONS: In our experience with relatively small adult population, adherence to KD is difficult. In patients who had compliance over 3 weeks (6/8), KD does not seem to have a significant effect. Yet, the significant reduction in the two patients who concluded the study per protocol may indicate that some patients may benefit from this diet. Significant increase in LDL levels and the unlikable dietary changes are additional impediments to its implementation among adults with refractory epilepsy.

The obesity of patients with Laron Syndrome is not associated with excessive nutritional intake.

OBJECTIVE: To study the metabolic parameters which may affect the excessive weight of treated and untreated patients with Laron Syndrome. DESIGN: Body composition, daily caloric intake and resting energy expenditure (REE), when possible, were measured for each patient. Caloric intake was calculated based on 7-day food records, REE was measured by indirect calorimetry and body composition was determined by dual energy X-ray absorptiometry (DEXA). SUBJECTS: Nine untreated adult subjects with Laron Syndrome (6 female subjects, 3 male subjects) aged 28-53 years and 4 girls with Laron Syndrome treated by insulin-like growth factor-I (IGF-I) 120-150 µg/kg/d were included in the study. RESULTS: Patients with Laron Syndrome have an abnormally high body fat (BF) mass (54 ± 10% of body weight) and a relatively low lean body mass (LBM) compared to a healthy normal population. Energy intake varied but in most of the patients was not significantly higher than the measured REE. The REE corrected for LBM was higher than expected, based on our norms for healthy adults. The mean distribution of energy sources in the food was 47% carbohydrates, 17% protein and 36% fat. CONCLUSION: The severe obesity of patients with Laron Syndrome is not due to hyperphagia or hypometabolism.

Correlation between changes in blood fatty acid composition and visual sustained attention performance in children with inattention: effect of dietary n-3 fatty acids containing phospholipids.

BACKGROUND: Increasing evidence supports n-3 fatty acid (FA) supplementation for patients with psychiatric disorders, such as attention deficit hyperactivity disorder. However, the exact metabolic fate of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on different glyceride carriers remains unclear. OBJECTIVE: We investigated whether conjugation of EPA and DHA to phospholipid (PL-n-3) or to triacylglycerol (fish oil; FO) affects their incorporation in blood compartments and influences executive functioning. DESIGN: Children aged 8-13 y with impaired visual sustained attention performance received placebo, 250 mg/d EPA + DHA esterified to PL-n-3 (300 mg/d phosphatidylserine), or FO for 3 mo in a randomized double-blind manner. Main outcome measures included plasma and erythrocyte FA profile and continuous performance test results (Test of Variables of Attention; TOVA). RESULTS: Sixty of the 83 children enrolled completed the interventions (n = 18-21 per group). There was an enrichment of EPA (1.5-2.2-fold), docosapentaenoic acid (DPA; 1.2-fold), and DHA (1.3-fold) in the PL fraction in the plasma of FO- and PL-n-3-fed children. In erythrocytes, only PL-n-3 resulted in a significant reduction (approximately 30%) of very-long-chain saturated FAs (C20-24) and in an increase (1.2- and 2.2-fold, respectively) in linoleic acid and DPA. Total TOVA scores increased in the PL-n-3 (mean +/- SD: 3.35 +/- 1.86) and FO (1.72 +/- 1.67) groups but not in the placebo group (-0.42 +/- 2.51) (PL-n-3 > FO > placebo; P < 0.001). A significant correlation between the alterations in FAs and increased TOVA scores mainly occurred in the PL-n-3 group. CONCLUSION: Consumption of EPA+DHA esterified to different carriers had different effects on the incorporation of these FAs in blood fractions and on the visual sustained attention performance in children. This trial was registered at clinicaltrials.gov as NCT00382616.