Mapping ongoing nutrition intervention trials in muscle, sarcopenia, and cachexia: a scoping review of future research

Abstract

Muscle loss alone, or in the context of sarcopenia or cachexia, is a prevalent condition and a predictor of negative outcomes in aging and disease. As adequate nutrition is essential for muscle maintenance, a growing number of studies has been conducted to explore the role of specific nutrients on muscle mass or function. Nonetheless, more research is needed to guide evidence-based recommendations. This scoping review aimed to compile and document ongoing clinical trials investigating nutrition interventions as a strategy to prevent or treat low muscle mass or function (strength and physical performance), sarcopenia, or cachexia. ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform were searched up to 21 April 2021 for planned and ongoing trials. Randomized controlled trials with ≥20 participants per arm were included based on intent to explore the effects of nutrition interventions on muscle-related outcomes (i.e. muscle mass or strength, physical performance, or muscle synthesis rate) in both clinical and non-clinical conditions (i.e. aging). Two reviewers independently screened records for eligibility, and a descriptive synthesis of trials characteristics was conducted. A total of 113 trials were included in the review. Most trials (69.0%) enroll adults with clinical conditions, such as cancer (19.5%), obesity and metabolic diseases (16.8%), and musculoskeletal diseases (10.7%). The effects of nutrition interventions on age-related muscle loss are explored in 31% of trials. Although nutrition interventions of varied types were identified, food supplements alone (48.7%) or combined with dietary advice (11.5%) are most frequently reported. Protein (17.7%), amino acids (10.6%), and β-hydroxy-β-methylbutyrate (HMB, 6.2%) are the top three food supplements' nutrients under investigation. Primary outcome of most trials (54.9%) consists of measures of muscle mass alone or in combination with muscle strength and/or performance (as either primary or secondary outcomes). Muscle strength and physical performance are primary outcomes of 38% and 31.9% of the trials, respectively. These measurements were obtained using a variety of techniques. Only a few trials evaluate muscle synthesis rate either as a primary or secondary outcome (5.3%). Several nutrition studies focusing on muscle, sarcopenia, and cachexia are underway and can inform future research in this area. Although many trials have similar type of interventions, methodological heterogeneity may challenge study comparisons, and future meta-analyses aiming to provide evidence-based recommendations. Upcoming research in this area may benefit from guidelines for the assessment of therapeutic effects of nutrition interventions.

Effects of β‐hydroxy β‐methylbutyrate (HMB) supplementation on muscle mass, function, and other outcomes in patients with cancer: a systematic review

“…Given the potential yet limited evidence on the effects of HMB supplementation in patients with cancer, future studies are needed to advance our understanding. A recent scoping review of registered clinical trials investigating nutrition interventions targeting muscle‐related outcomes revealed that 3 of 22 RCTs are evaluating the effects of HMB supplementation in this population 93 . Of these ongoing studies, dietary advice with the goal of achieving a high‐protein diet is provided in one but none are investigating the effects of HMB‐enriched ONS.…”

“…A recent scoping review of registered clinical trials investigating nutrition interventions targeting muscle‐related outcomes revealed that 3 of 22 RCTs are evaluating the effects of HMB supplementation in this population. 93 Of these ongoing studies, dietary advice with the goal of achieving a high‐protein diet is provided in one but none are investigating the effects of HMB‐enriched ONS. Notably, it is also unclear if other strategies are being used to optimize nutritional status in these studies, which may make it difficult to fully evaluate the effect of HMB in mitigating muscle and function loss, especially in patients with cancer who develop malnutrition along the course of the study.…”

Effects of a New Multicomponent Nutritional Supplement on Muscle Mass and Physical Performance in Adult and Old Patients Recovered from COVID-19: A Pilot Observational Case–Control Study

“…International guidelines and expert consensus recommend appropriate and timely nutritional evaluation and specific approaches to improve clinical outcomes in subjects at higher risk of developing nutritional problems, including subjects with chronic and/or severe diseases in different healthcare settings [ 6 , 15 , 16 ]. The present study suggests and confirms the importance of nutritional supplementation in subjects suffering from an infection and catabolic disease, such as COVID-19.…”

Advances in muscle health and nutrition: A toolkit for healthcare professionals

“…Likewise, nutrients such as protein/amino acids, vitamin D, n-3 polyunsaturated fatty acids (n-3 PUFA), b-hydroxy-b-methylbutyrate (HMB), and polyphenols can support muscle health and recovery by affecting both muscle and immune function, demonstrating the interaction between muscle and immune systems. These are and other nutritional strategies are actively being explored in nutrition intervention trials focusing on muscle mass, sarcopenia and cachexia [160]. Because achieving nutritional intake goals in older adults and clinical populations may be challenging, individualized nutritional counseling should be offered concurrent to nutrition therapy, as endorsed by nutrition care guidelines [161,162].…”

“…Furthermore, more research is required to explore the impact of nutrition and exercise interventions to maximize anabolic potential, physical performance, and outcomes in healthy aging, and acute and chronic disease, including acute conditions like COVID-19. Recommendations for future nutrition trials have been provided in order to rapidly advance knowledge translation of interventions addressing muscle, sarcopenia and cachexia to clinical practice [160].…”