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

Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial
Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial
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.
2190-5991
28-40
Calder, Philip
1797e54f-378e-4dcb-80a4-3e30018f07a6
Laviano, Alessandro
931fbfb5-de70-467b-b584-02ccd80be0a1
Lonnqvist, Fredrik
b48f7dfc-25ac-40b9-b019-9c22add78cc1
Muscaritoli, Maurizio
43f02a2d-38b4-4e9a-b7e5-76ed2ff7282e
Öhlander, Maria
ea29320b-0dde-4270-8bf4-f6aa5265e5b7
Schols, Annemie
3e5e6f9d-39a3-48c6-b2d0-d5fb72c8cf33
Calder, Philip
1797e54f-378e-4dcb-80a4-3e30018f07a6
Laviano, Alessandro
931fbfb5-de70-467b-b584-02ccd80be0a1
Lonnqvist, Fredrik
b48f7dfc-25ac-40b9-b019-9c22add78cc1
Muscaritoli, Maurizio
43f02a2d-38b4-4e9a-b7e5-76ed2ff7282e
Öhlander, Maria
ea29320b-0dde-4270-8bf4-f6aa5265e5b7
Schols, Annemie
3e5e6f9d-39a3-48c6-b2d0-d5fb72c8cf33

Calder, Philip, Laviano, Alessandro, Lonnqvist, Fredrik, Muscaritoli, Maurizio, Öhlander, Maria and Schols, Annemie (2018) Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial. Journal of Cachexia, Sarcopenia and Muscle, 9 (1), 28-40. (doi:10.1002/jcsm.12228).

Record type: Article

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.

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More information

Accepted/In Press date: 5 July 2017
e-pub ahead of print date: 10 September 2017
Published date: February 2018

Identifiers

Local EPrints ID: 412079
URI: http://eprints.soton.ac.uk/id/eprint/412079
ISSN: 2190-5991
PURE UUID: 3de4f251-fe90-4a66-b339-dede7c71d15a

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Date deposited: 06 Jul 2017 16:30
Last modified: 17 Dec 2019 06:03

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