Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial

Abstract Background Cachectic patients with chronic obstructive pulmonary disease (COPD) may benefit from nutritional support. This double‐blind, randomized, controlled trial evaluated the safety and efficacy of targeted medical nutrition (TMN) vs. an isocaloric comparator in pre‐cachectic and cache...

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Main Authors: Philip C. Calder, Alessandro Laviano, Fredrik Lonnqvist, Maurizio Muscaritoli, Maria Öhlander, Annemie Schols
Format: Article
Language:English
Published: Wiley 2018-02-01
Series:Journal of Cachexia, Sarcopenia and Muscle
Subjects:
Online Access:https://doi.org/10.1002/jcsm.12228
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spelling doaj-5bb1b2a549c44ce98feb3abeb996234b2020-11-24T21:40:42ZengWileyJournal of Cachexia, Sarcopenia and Muscle2190-59912190-60092018-02-0191284010.1002/jcsm.12228Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trialPhilip C. Calder0Alessandro Laviano1Fredrik Lonnqvist2Maurizio Muscaritoli3Maria Öhlander4Annemie Schols5Human Development and Health Academic Unit, Faculty of Medicine University of Southampton Tremona Road, SO16 6YD Southampton UKDepartment of Clinical Medicine Sapienza University of Rome Rome ItalyDepartment of Molecular Medicine and Surgery and the Center for Molecular Medicine Karolinska Institute Stockholm SwedenDepartment of Clinical Medicine Sapienza University of Rome Rome ItalySmartfish AS Oslo NorwayDepartment of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism Maastricht University Medical Centre Maastricht NetherlandsAbstract Background Cachectic patients with chronic obstructive pulmonary disease (COPD) may benefit from nutritional support. This double‐blind, randomized, controlled trial evaluated the safety and efficacy of targeted medical nutrition (TMN) vs. an isocaloric comparator in pre‐cachectic and cachectic patients with COPD. Methods Patients aged ≥50 years with moderate‐to‐severe COPD and involuntary weight loss or low body mass index (16–18 kg/m2) were randomized 1:1 to receive TMN (~230 kcal; 2 g omega‐3 fatty acids; 10 μg 25‐hydroxy‐vitamin D3) or isocaloric comparator twice daily for 12 weeks (ClinicalTrials.gov Identifier: NCT02442908). Primary safety endpoints comprised adverse events and changes in vital signs, laboratory parameters, and concomitant medications. Secondary efficacy endpoints included changes in weight, body composition, exercise tolerance, metabolic biomarkers, and systemic inflammation. Results Forty‐five patients were randomized to receive TMN (n = 22; mean 69.2 years) or isocaloric comparator (n = 23; mean 69.7 years). TMN was well tolerated. Adverse events were similar in number and type in both groups. Compliance to both products was good (TMN, 79%; comparator, 77%). Both groups gained weight, but the TMN group gained comparatively more fat mass (P = 0.0013). Reductions in systolic blood pressure (P = 0.0418) and secondary endpoints of triglycerides (P = 0.0217) and exercise‐induced fatigue (P = 0.0223) and dyspnoea (P = 0.0382), and increases in high‐density lipoprotein cholesterol (P = 0.0254), were observed in the TMN vs. the comparator group by week 12. Conclusions Targeted medical nutrition containing high‐dose omega‐3 fatty acids, vitamin D, and high‐quality protein is well tolerated with a good safety profile and has positive effects on blood pressure and blood lipids and on exercise‐induced fatigue and dyspnoea. Therefore, this TMN could be clinically beneficial in the nutritional and metabolic support of pre‐cachectic and cachectic patients with COPD.https://doi.org/10.1002/jcsm.12228CachexiaChronic obstructive pulmonary diseaseNutritionOmega‐3 fatty acidsPre‐cachexia
collection DOAJ
language English
format Article
sources DOAJ
author Philip C. Calder
Alessandro Laviano
Fredrik Lonnqvist
Maurizio Muscaritoli
Maria Öhlander
Annemie Schols
spellingShingle Philip C. Calder
Alessandro Laviano
Fredrik Lonnqvist
Maurizio Muscaritoli
Maria Öhlander
Annemie Schols
Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial
Journal of Cachexia, Sarcopenia and Muscle
Cachexia
Chronic obstructive pulmonary disease
Nutrition
Omega‐3 fatty acids
Pre‐cachexia
author_facet Philip C. Calder
Alessandro Laviano
Fredrik Lonnqvist
Maurizio Muscaritoli
Maria Öhlander
Annemie Schols
author_sort Philip C. Calder
title Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial
title_short Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial
title_full Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial
title_fullStr Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial
title_full_unstemmed Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial
title_sort targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial
publisher Wiley
series Journal of Cachexia, Sarcopenia and Muscle
issn 2190-5991
2190-6009
publishDate 2018-02-01
description Abstract Background Cachectic patients with chronic obstructive pulmonary disease (COPD) may benefit from nutritional support. This double‐blind, randomized, controlled trial evaluated the safety and efficacy of targeted medical nutrition (TMN) vs. an isocaloric comparator in pre‐cachectic and cachectic patients with COPD. Methods Patients aged ≥50 years with moderate‐to‐severe COPD and involuntary weight loss or low body mass index (16–18 kg/m2) were randomized 1:1 to receive TMN (~230 kcal; 2 g omega‐3 fatty acids; 10 μg 25‐hydroxy‐vitamin D3) or isocaloric comparator twice daily for 12 weeks (ClinicalTrials.gov Identifier: NCT02442908). Primary safety endpoints comprised adverse events and changes in vital signs, laboratory parameters, and concomitant medications. Secondary efficacy endpoints included changes in weight, body composition, exercise tolerance, metabolic biomarkers, and systemic inflammation. Results Forty‐five patients were randomized to receive TMN (n = 22; mean 69.2 years) or isocaloric comparator (n = 23; mean 69.7 years). TMN was well tolerated. Adverse events were similar in number and type in both groups. Compliance to both products was good (TMN, 79%; comparator, 77%). Both groups gained weight, but the TMN group gained comparatively more fat mass (P = 0.0013). Reductions in systolic blood pressure (P = 0.0418) and secondary endpoints of triglycerides (P = 0.0217) and exercise‐induced fatigue (P = 0.0223) and dyspnoea (P = 0.0382), and increases in high‐density lipoprotein cholesterol (P = 0.0254), were observed in the TMN vs. the comparator group by week 12. Conclusions Targeted medical nutrition containing high‐dose omega‐3 fatty acids, vitamin D, and high‐quality protein is well tolerated with a good safety profile and has positive effects on blood pressure and blood lipids and on exercise‐induced fatigue and dyspnoea. Therefore, this TMN could be clinically beneficial in the nutritional and metabolic support of pre‐cachectic and cachectic patients with COPD.
topic Cachexia
Chronic obstructive pulmonary disease
Nutrition
Omega‐3 fatty acids
Pre‐cachexia
url https://doi.org/10.1002/jcsm.12228
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