NCT03807310

Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)

The Effect of Targeted Nutrient Supplementation on Physical Activity and Healthy Related Quality of Life in COPD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objective is to investigate the efficacy of targeted nutrient supplementation on daily physical activity level as well as generic health status in patients with COPD. Additionally the investigators aim to investigate the relative effect of targeted nutrient supplementation on the recovery after hospitalization for a COPD exacerbation. The secondary objective is to investigate the effect of targeted nutrient supplementation on mental health, physical performance, blood markers, patient related outcomes and gut health. Additionally, a secondary objective is to compare the gut microbiome composition of patients with COPD compared to healthy controls.

Detailed description

Rationale: Impaired physical and mental health are common features in COPD adversely affecting disease course and quality of life. Furthermore, nutritional status is often impaired due to dietary and plasma nutrient deficiencies, decreased muscle oxidative metabolism and impaired intestinal permeability. The investigators hypothesize that targeted nutrient supplementation can lead to gut-muscle-brain axis-mediated amelioration of physical, cognitive and mental health domains, resulting in a healthier lifestyle, in patients with COPD. Study design: Randomized, placebo-controlled, double-blind trial. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The nutrient supplement is hypothesized to have beneficial effects on general health because it applies physical and mental health domains. The healthy lifestyle counselling aims to improve medical adherence, to address a healthier lifestyle and to manage weight loss which would contribute to improved general health. Risks and inconveniences are limited to the time investment associated with taking the supplements and measuring days. During the test-days various non-invasive measurements as well as minor invasive blood sampling will be performed. The investigators expect no risk of the nutrient supplementation. Healthy controls will only attend a subgroup of baseline measurements which are limited to non-invasive measurements and one minor invasive blood sampling. Healthy controls will not receive the nutritional supplement.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Targeted nutrient supplementation (Long-drink)	Once daily for at least 12 months
DIETARY_SUPPLEMENT	Placebo supplement	Once daily for at least 12 months
BEHAVIORAL	Counselling	Counselling on healthy lifestyle (in particular physical activity, smoking cessation) and weight management by motivational interviewing

Timeline

• Start date: 2020-02-19
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2019-01-16
• Last updated: 2025-01-14

Locations

1 site across 1 country: Netherlands