Hypercaloric enteral nutrition in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled phase 2 trial

Wills, Anne Marie; Hubbard, Jane; Macklin, Eric A.; Glass, Jonathan D.; Tandan, Rup; Simpson, Ericka; Brooks, Benjamin Rix; Gelinas, Deborah; Mitsumoto, Hiroshi; Mozaffar, Tahseen; Hanes, Gregory P.; Ladha, Shafeeq; Heiman‐Patterson, Terry; Katz, Jonathan; Lou, Jau Shin; Mahoney, Katy; Grasso, Daniela; Lawson, Robert; Yu, Hong; Cudkowicz, Merit

doi:10.1016/s0140-6736(14)60222-1

Cited by 239 publications

(210 citation statements)

References 29 publications

(30 reference statements)

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“…Clinical studies in ALS have revealed adiposity to be a predictor of ALS mortality (1), disease progression (2), and survival (3). As such, there is increasing interest in preventing loss of fat mass (FM) in ALS via nutritional intervention (4)(5)(6)(7). To optimise nutritional management strategies, accurate measures of adiposity are critical.…”

Section: Introductionmentioning

confidence: 99%

Anthropometric measures are not accurate predictors of fat mass in ALS

Ioannides

Steyn

Henderson

et al. 2017

Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

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Background: Anthropometric measurements including body mass index (BMI) and body adiposity index (BAI) are widely employed as indicators of fat mass (FM). Metabolic abnormalities in amyotrophic lateral sclerosis (ALS) impact disease progression, therefore assessment of FM informs care. The aim of this study was to determine whether BMI and BAI are accurate predictors of FM in ALS. Methodology and main findings: BMI, BAI and percentage FM (determined by air displacement plethysmography; FM-ADP) were measured in control (n ¼ 35) and ALS (n ¼ 44) participants. While BMI and BAI correlated significantly with FM-ADP, neither index provided an accurate estimate of FM. In longitudinally assessed ALS participants (n ¼ 29; $six-month repeat assessment interval), although a change in BMI (r 2 ¼ 0.62 r ¼ 0.79 p50.01) and BAI (r 2 ¼ 0.20 r ¼ 0.44, p ¼ 0.02) correlated with a change in FM-ADP, the anthropometric measures did not consistently reflect increases or decreases observed in FM-ADP. Conclusions/significance: Using FM-ADP as the standard, this study suggests that BMI and BAI are not accurate measures of FM in ALS. Furthermore, longitudinal assessments indicate that changes in BMI and BAI do not consistently reflect true changes of FM in ALS.

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Section: Introductionmentioning

confidence: 99%

Anthropometric measures are not accurate predictors of fat mass in ALS

Ioannides

Steyn

Henderson

et al. 2017

Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

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“…As a corollary, interventions aiming at preventing weight loss, such as hypercaloric nutrition, should be beneficial. The tolerance and safety of such an intervention was tested in 24 patients under enteral nutrition, randomized to hypercaloric high-carbohydrate (HC) nutrition, hypercaloric high-fat nutrition, or isocaloric (C) nutrition, for 4 mo and followed up to 5 mo [3]. At baseline, patients had a BMI in the normal range but a body weight loss of almost 20%.…”

Section: Weight Change and Survivalmentioning

confidence: 99%

“…An increase in FM predicts a better survival [7]. Using DXA, one study showed that patients who gained weight increased FM and FFM, whereas those who lost weight lost FFM but increased FM [3]. This suggests that loss of FFM may be a better predictor of mortality than loss of FM.…”

Section: Body Weight Versus Body Compositionmentioning

confidence: 99%

“…A multidisciplinary approach [1], non-invasive ventilation [2], riluzole, and enteral nutrition via percutaneous endoscopic gastrostomy have been shown to improve survival and quality of life to some extent [1]. In a recently published article, it was postulated that a nutritional intervention, aiming at achieving weight gain, might be a therapeutic option for patients with ALS [3]. These assumptions relied on the increased survival with a high-calorie diet in an ALS mouse model [4] and on the lower risk for ALS in overweight or obese individuals [5].…”

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confidence: 99%

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Should patients with ALS gain weight during their follow-up?

et al. 2015

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a b s t r a c tIt was recently postulated that a nutritional intervention aiming at achieving weight gain might increase survival in ALS patients. This article discusses the effect of nutritional status and weight gain on survival, respiratory status and physical function. Based on the available literature, it remains unknown whether weight gain during the progression of the disease improves survival whatever the baseline body weight is. A high body mass index may impair respiratory muscle function and passive mobilization of paretic patients. Future research should evaluate the effect of changes in weight and body composition on clinical outcome while taking into account respiratory muscle strength and physical function.Ó 2015 Elsevier Inc. All rights reserved.Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with a life expectancy of 2 to 5 y. Effective treatment for ALS is lacking. A multidisciplinary approach [1], non-invasive ventilation [2], riluzole, and enteral nutrition via percutaneous endoscopic gastrostomy have been shown to improve survival and quality of life to some extent [1]. In a recently published article, it was postulated that a nutritional intervention, aiming at achieving weight gain, might be a therapeutic option for patients with ALS [3]. These assumptions relied on the increased survival with a high-calorie diet in an ALS mouse model [4] and on the lower risk for ALS in overweight or obese individuals [5].Here we summarize the effect of initial nutritional status and weight gain during follow-up on survival and respiratory and physical function to explore whether weight gain is beneficial for patients with ALS.Weight and body mass index at diagnosis and survival A study of 92 patients with ALS demonstrated that a history of weight loss at diagnosis was significantly associated with survival [7]. After adjustment for age, sex, bulbar versus non-bulbar onset, ALS functional rating scale (ALSFRS), manual muscular testing, forced vital capacity, and diagnostic delay, the study found a 30% increase in risk for death for each 5% weight loss and a 20% increase in risk for death for each BMI unit loss.In the same study population, undernutrition at diagnosis, defined as a BMI <18.5 kg/m 2 if <70 y or <21 kg/m 2 if 70 y (n ¼ 8), was not associated with survival, after the aforementioned adjustments [7]. Effect of obesity was not assessed. A larger study stratified 285 patients with ALS according to BMI categories at baseline [8]. BMI categories were not predictive of survival or rate of progression. However, only 3 patients were undernourished and 65 were obese. A shorter survival in patients with ALS and a baseline BMI <18.5 kg/m 2 (n ¼ 9) than in those with a higher BMI was reported in univariate Cox regressions [9]. One group of researchers studied 427 patients with ALS [10]. A decreased survival was seen in patients with a BMI >35 or <18.5 kg/m 2 at diagnosis; thus a U-shaped relationship between BMI and survival was established. This finding was confirmed in the PRO-ACT (Po...

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“…Given the association between loss of adiposity and poorer survival (Paganoni et al, 2011, Shimizu et al, 2012, Gallo et al, 2013, Lindauer et al, 2013, there is increasing interest in the maintenance of FM in ALS via invasive nutritional interventions (Mazzini et al, 199527, Muscaritoli et al, 2012, Wills et al, 2014. Nutritional supplementation is a rapidly emerging area in the field of ALS therapeutics (Rosenfeld and Ellis, 2008) and enteral nutrition has become an important aspect of therapy in some ALS patients.…”

Section: Nutritional Interventionsmentioning

confidence: 99%

Energy metabolism in amyotrophic lateral sclerosis: assessment of body composition and energy expenditure

Ioannides¹

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Hypercaloric enteral nutrition in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled phase 2 trial

Cited by 239 publications

References 29 publications

Anthropometric measures are not accurate predictors of fat mass in ALS

Anthropometric measures are not accurate predictors of fat mass in ALS

Should patients with ALS gain weight during their follow-up?

Energy metabolism in amyotrophic lateral sclerosis: assessment of body composition and energy expenditure

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