Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial

Martijn van Beers; Maureen P. M. H. Rutten-van Molken; Coby van de Bool; Melinde Boland; Stef P. J. Kremers; Frits M. E. Franssen; Ardy van Helvoort; Harry R. Gosker; Emiel E. Wouters; Annemie M. W. J. Schols

doi:10.1016/j.clnu.2019.03.001

Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial

Martijn van Beers, Maureen P. M. H. Rutten-van Molken, Coby van de Bool, Melinde Boland, Stef P. J. Kremers, Frits M. E. Franssen, Ardy van Helvoort, Harry R. Gosker, Emiel E. Wouters, Annemie M. W. J. Schols^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Background and aims: The efficacy of nutritional intervention to enhance short- and long-term outcomes of pulmonary rehabilitation in COPD is still unclear, hence this paper aims to investigate the clinical outcome and cost-effectiveness of a 12-month nutritional intervention strategy in muscle-wasted COPD patients.

Methods: Prior to a 4-month pulmonary rehabilitation programme, 81 muscle-wasted COPD patients (51% males, aged 62.5 +/- 0.9 years) with moderate airflow obstruction (FEV1 55.1 +/- 2.2% predicted) and impaired exercise capacity (W-max 63.5 +/- 2.4% predicted) were randomized to 3 portions of nutritional supplementation per day (enriched with leucine, vitamin D and polyunsaturated fatty acids) [NUTRITION] or PLACEBO (phase 1). In the unblinded 8-month maintenance phase (phase 2), both groups received structured feedback on their physical activity level assessed by accelerometry. NUTRITION additionally received 1 portion of supplemental nutrition per day and motivational interviewing-based nutritional counselling. A 3-month follow-up (phase 3) was included.

Results: After 12 months, physical capacity measured by quadriceps muscle strength and cycle endurance time were not different, but physical activity was higher in NUTRITION than in PLACEBO (Delta 1030 steps/day, p = 0.025). Plasma levels of the enriched nutrients (p <0.001) were higher in NUTRITION than PLACEBO. Trends towards weight gain in NUTRITION and weight loss in PLACEBO led to a significant between-group difference after 12 months (Delta 1.54 kg, p = 0.041). The HADS anxiety and depression scores improved in NUTRITION only (Delta 1.92 points, p = 0.037). Generic quality of life (EQ-5D) was decreased in PLACEBO but not in NUTRITION (between-group difference after 15 months 0.072 points, p = 0.009). Overall motivation towards exercising and healthy eating was high and did not change significantly after 12 months: only amotivation towards healthy eating yielded a significant between-group difference (Delta 1.022 points, p = 0.015). The cost per quality-adjusted life-year after 15 months was EUR 16,750.

Conclusions: Nutritional intervention in muscle-wasted patients with moderate COPD does not enhance long-term outcome of exercise training on physical capacity but ameliorates plasma levels of the supplemented nutrients, total body weight, physical activity and generic health status, at an acceptable increase of costs for patients with high disease burden. (C) 2019 The Author(s). Published by Elsevier Ltd.

Original language	English
Pages (from-to)	405-413
Number of pages	9
Journal	Clinical Nutrition
Volume	39
Issue number	2
DOIs	https://doi.org/10.1016/j.clnu.2019.03.001
Publication status	Published - Feb 2020

Keywords

COPD
Physical activity
Cost-effectiveness
Nutritional intervention
OBSTRUCTIVE PULMONARY-DISEASE
EXERCISE
SUPPLEMENTATION
REHABILITATION
BENEFITS
QUALITY

Access to Document

10.1016/j.clnu.2019.03.001Licence: CC BY-NC-ND

Cite this

van Beers, M., Rutten-van Molken, M. P. M. H., van de Bool, C., Boland, M., Kremers, S. P. J., Franssen, F. M. E., van Helvoort, A., Gosker, H. R., Wouters, E. E., & Schols, A. M. W. J. (2020). Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial. Clinical Nutrition, 39(2), 405-413. https://doi.org/10.1016/j.clnu.2019.03.001

@article{2659c6bac7134d00a148eab37c5dba5c,

title = "Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial",

abstract = "Background and aims: The efficacy of nutritional intervention to enhance short- and long-term outcomes of pulmonary rehabilitation in COPD is still unclear, hence this paper aims to investigate the clinical outcome and cost-effectiveness of a 12-month nutritional intervention strategy in muscle-wasted COPD patients.Methods: Prior to a 4-month pulmonary rehabilitation programme, 81 muscle-wasted COPD patients (51% males, aged 62.5 +/- 0.9 years) with moderate airflow obstruction (FEV1 55.1 +/- 2.2% predicted) and impaired exercise capacity (W-max 63.5 +/- 2.4% predicted) were randomized to 3 portions of nutritional supplementation per day (enriched with leucine, vitamin D and polyunsaturated fatty acids) [NUTRITION] or PLACEBO (phase 1). In the unblinded 8-month maintenance phase (phase 2), both groups received structured feedback on their physical activity level assessed by accelerometry. NUTRITION additionally received 1 portion of supplemental nutrition per day and motivational interviewing-based nutritional counselling. A 3-month follow-up (phase 3) was included.Results: After 12 months, physical capacity measured by quadriceps muscle strength and cycle endurance time were not different, but physical activity was higher in NUTRITION than in PLACEBO (Delta 1030 steps/day, p = 0.025). Plasma levels of the enriched nutrients (p <0.001) were higher in NUTRITION than PLACEBO. Trends towards weight gain in NUTRITION and weight loss in PLACEBO led to a significant between-group difference after 12 months (Delta 1.54 kg, p = 0.041). The HADS anxiety and depression scores improved in NUTRITION only (Delta 1.92 points, p = 0.037). Generic quality of life (EQ-5D) was decreased in PLACEBO but not in NUTRITION (between-group difference after 15 months 0.072 points, p = 0.009). Overall motivation towards exercising and healthy eating was high and did not change significantly after 12 months: only amotivation towards healthy eating yielded a significant between-group difference (Delta 1.022 points, p = 0.015). The cost per quality-adjusted life-year after 15 months was EUR 16,750.Conclusions: Nutritional intervention in muscle-wasted patients with moderate COPD does not enhance long-term outcome of exercise training on physical capacity but ameliorates plasma levels of the supplemented nutrients, total body weight, physical activity and generic health status, at an acceptable increase of costs for patients with high disease burden. (C) 2019 The Author(s). Published by Elsevier Ltd.",

keywords = "COPD, Physical activity, Cost-effectiveness, Nutritional intervention, OBSTRUCTIVE PULMONARY-DISEASE, EXERCISE, SUPPLEMENTATION, REHABILITATION, BENEFITS, QUALITY",

author = "{van Beers}, Martijn and {Rutten-van Molken}, {Maureen P. M. H.} and {van de Bool}, Coby and Melinde Boland and Kremers, {Stef P. J.} and Franssen, {Frits M. E.} and {van Helvoort}, Ardy and Gosker, {Harry R.} and Wouters, {Emiel E.} and Schols, {Annemie M. W. J.}",

note = "Funding Information: Mr. Van Beers, Dr. Rutten-Van Molken, Dr. Boland, Prof. Kremers and Dr. Gosker report no disclosures. Dr. Van de Bool reports grants from the Lung Foundation Netherlands and Nutricia Research during the conduct of the study. Dr. Franssen reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Novartis, GlaxoSmithKline and TEVA outside the submitted work. Dr. Van Helvoort reports a grant for this study as it was financially supported by a public-private consortium of Maastricht University/NUTRIM, CIRO+ BV Horn, Nutricia Research and the Lung Foundation Netherlands (grant 3.4.09.003), personal fees as employee at Nutricia Research during the conduct of the study and personal fees as employee at Nutricia Research outside the submitted work. In addition Dr. Van Helvoorta/Nutricia has a patent WO2008NL50047 20080702 issued covering the product. Prof. Wouters reports personal fees from Nycomed, Boehringer, AstraZeneca, GSK, Novartis and Chiesi. Prof. Schols reports grants from Nutricia Advanced Medical Nutrition. Funding Information: This study was supported by grants by the Lung Foundation Netherlands (grant 3.4.09.003 ), ZonMW (JPI-HDHL project {"}Ambrosiac{"}, project number 529051006 ), and Nutricia Advanced Medical Nutrition . These funding agencies were not involved in the study design, the collection, analysis and interpretation of data, writing the report, and the decision to submit the article for publication. Publisher Copyright: {\textcopyright} 2019 The Author(s)",

year = "2020",

month = feb,

doi = "10.1016/j.clnu.2019.03.001",

language = "English",

volume = "39",

pages = "405--413",

journal = "Clinical Nutrition",

issn = "0261-5614",

publisher = "Churchill Livingstone",

number = "2",

}

van Beers, M, Rutten-van Molken, MPMH, van de Bool, C, Boland, M, Kremers, SPJ , Franssen, FME , van Helvoort, A , Gosker, HR , Wouters, EE & Schols, AMWJ 2020, 'Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial', Clinical Nutrition, vol. 39, no. 2, pp. 405-413. https://doi.org/10.1016/j.clnu.2019.03.001

Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial. / van Beers, Martijn; Rutten-van Molken, Maureen P. M. H.; van de Bool, Coby et al.
In: Clinical Nutrition, Vol. 39, No. 2, 02.2020, p. 405-413.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass

T2 - The randomized controlled NUTRAIN trial

AU - van Beers, Martijn

AU - Rutten-van Molken, Maureen P. M. H.

AU - van de Bool, Coby

AU - Boland, Melinde

AU - Kremers, Stef P. J.

AU - Franssen, Frits M. E.

AU - van Helvoort, Ardy

AU - Gosker, Harry R.

AU - Wouters, Emiel E.

AU - Schols, Annemie M. W. J.

N1 - Funding Information: Mr. Van Beers, Dr. Rutten-Van Molken, Dr. Boland, Prof. Kremers and Dr. Gosker report no disclosures. Dr. Van de Bool reports grants from the Lung Foundation Netherlands and Nutricia Research during the conduct of the study. Dr. Franssen reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Novartis, GlaxoSmithKline and TEVA outside the submitted work. Dr. Van Helvoort reports a grant for this study as it was financially supported by a public-private consortium of Maastricht University/NUTRIM, CIRO+ BV Horn, Nutricia Research and the Lung Foundation Netherlands (grant 3.4.09.003), personal fees as employee at Nutricia Research during the conduct of the study and personal fees as employee at Nutricia Research outside the submitted work. In addition Dr. Van Helvoorta/Nutricia has a patent WO2008NL50047 20080702 issued covering the product. Prof. Wouters reports personal fees from Nycomed, Boehringer, AstraZeneca, GSK, Novartis and Chiesi. Prof. Schols reports grants from Nutricia Advanced Medical Nutrition. Funding Information: This study was supported by grants by the Lung Foundation Netherlands (grant 3.4.09.003 ), ZonMW (JPI-HDHL project "Ambrosiac", project number 529051006 ), and Nutricia Advanced Medical Nutrition . These funding agencies were not involved in the study design, the collection, analysis and interpretation of data, writing the report, and the decision to submit the article for publication. Publisher Copyright: © 2019 The Author(s)

PY - 2020/2

Y1 - 2020/2

N2 - Background and aims: The efficacy of nutritional intervention to enhance short- and long-term outcomes of pulmonary rehabilitation in COPD is still unclear, hence this paper aims to investigate the clinical outcome and cost-effectiveness of a 12-month nutritional intervention strategy in muscle-wasted COPD patients.Methods: Prior to a 4-month pulmonary rehabilitation programme, 81 muscle-wasted COPD patients (51% males, aged 62.5 +/- 0.9 years) with moderate airflow obstruction (FEV1 55.1 +/- 2.2% predicted) and impaired exercise capacity (W-max 63.5 +/- 2.4% predicted) were randomized to 3 portions of nutritional supplementation per day (enriched with leucine, vitamin D and polyunsaturated fatty acids) [NUTRITION] or PLACEBO (phase 1). In the unblinded 8-month maintenance phase (phase 2), both groups received structured feedback on their physical activity level assessed by accelerometry. NUTRITION additionally received 1 portion of supplemental nutrition per day and motivational interviewing-based nutritional counselling. A 3-month follow-up (phase 3) was included.Results: After 12 months, physical capacity measured by quadriceps muscle strength and cycle endurance time were not different, but physical activity was higher in NUTRITION than in PLACEBO (Delta 1030 steps/day, p = 0.025). Plasma levels of the enriched nutrients (p <0.001) were higher in NUTRITION than PLACEBO. Trends towards weight gain in NUTRITION and weight loss in PLACEBO led to a significant between-group difference after 12 months (Delta 1.54 kg, p = 0.041). The HADS anxiety and depression scores improved in NUTRITION only (Delta 1.92 points, p = 0.037). Generic quality of life (EQ-5D) was decreased in PLACEBO but not in NUTRITION (between-group difference after 15 months 0.072 points, p = 0.009). Overall motivation towards exercising and healthy eating was high and did not change significantly after 12 months: only amotivation towards healthy eating yielded a significant between-group difference (Delta 1.022 points, p = 0.015). The cost per quality-adjusted life-year after 15 months was EUR 16,750.Conclusions: Nutritional intervention in muscle-wasted patients with moderate COPD does not enhance long-term outcome of exercise training on physical capacity but ameliorates plasma levels of the supplemented nutrients, total body weight, physical activity and generic health status, at an acceptable increase of costs for patients with high disease burden. (C) 2019 The Author(s). Published by Elsevier Ltd.

AB - Background and aims: The efficacy of nutritional intervention to enhance short- and long-term outcomes of pulmonary rehabilitation in COPD is still unclear, hence this paper aims to investigate the clinical outcome and cost-effectiveness of a 12-month nutritional intervention strategy in muscle-wasted COPD patients.Methods: Prior to a 4-month pulmonary rehabilitation programme, 81 muscle-wasted COPD patients (51% males, aged 62.5 +/- 0.9 years) with moderate airflow obstruction (FEV1 55.1 +/- 2.2% predicted) and impaired exercise capacity (W-max 63.5 +/- 2.4% predicted) were randomized to 3 portions of nutritional supplementation per day (enriched with leucine, vitamin D and polyunsaturated fatty acids) [NUTRITION] or PLACEBO (phase 1). In the unblinded 8-month maintenance phase (phase 2), both groups received structured feedback on their physical activity level assessed by accelerometry. NUTRITION additionally received 1 portion of supplemental nutrition per day and motivational interviewing-based nutritional counselling. A 3-month follow-up (phase 3) was included.Results: After 12 months, physical capacity measured by quadriceps muscle strength and cycle endurance time were not different, but physical activity was higher in NUTRITION than in PLACEBO (Delta 1030 steps/day, p = 0.025). Plasma levels of the enriched nutrients (p <0.001) were higher in NUTRITION than PLACEBO. Trends towards weight gain in NUTRITION and weight loss in PLACEBO led to a significant between-group difference after 12 months (Delta 1.54 kg, p = 0.041). The HADS anxiety and depression scores improved in NUTRITION only (Delta 1.92 points, p = 0.037). Generic quality of life (EQ-5D) was decreased in PLACEBO but not in NUTRITION (between-group difference after 15 months 0.072 points, p = 0.009). Overall motivation towards exercising and healthy eating was high and did not change significantly after 12 months: only amotivation towards healthy eating yielded a significant between-group difference (Delta 1.022 points, p = 0.015). The cost per quality-adjusted life-year after 15 months was EUR 16,750.Conclusions: Nutritional intervention in muscle-wasted patients with moderate COPD does not enhance long-term outcome of exercise training on physical capacity but ameliorates plasma levels of the supplemented nutrients, total body weight, physical activity and generic health status, at an acceptable increase of costs for patients with high disease burden. (C) 2019 The Author(s). Published by Elsevier Ltd.

KW - COPD

KW - Physical activity

KW - Cost-effectiveness

KW - Nutritional intervention

KW - OBSTRUCTIVE PULMONARY-DISEASE

KW - EXERCISE

KW - SUPPLEMENTATION

KW - REHABILITATION

KW - BENEFITS

KW - QUALITY

U2 - 10.1016/j.clnu.2019.03.001

DO - 10.1016/j.clnu.2019.03.001

M3 - Article

C2 - 30954363

SN - 0261-5614

VL - 39

SP - 405

EP - 413

JO - Clinical Nutrition

JF - Clinical Nutrition

IS - 2

ER -

Clinical outcome and cost-effectiveness of a 1-year nutritional intervention programme in COPD patients with low muscle mass: The randomized controlled NUTRAIN trial

Abstract

Keywords

Access to Document

Fingerprint

Cite this