Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Dietary Supplement: Targeted nutrient supplementation (Long-drink)Dietary Supplement: Placebo supplementBehavioral: Counselling
- Registration Number
- NCT03807310
- Lead Sponsor
- Maastricht University Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 166
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group Long-drink Counselling 83 COPD patients will receive: * Targeted nutrient supplementation (Long-drink) once daily * Counselling once monthly Group Placebo Counselling 83 COPD patients will receive: * Isocaloric placebo supplement once daily * Counselling once monthly Group Long-drink Targeted nutrient supplementation (Long-drink) 83 COPD patients will receive: * Targeted nutrient supplementation (Long-drink) once daily * Counselling once monthly Group Placebo Placebo supplement 83 COPD patients will receive: * Isocaloric placebo supplement once daily * Counselling once monthly
- Primary Outcome Measures
Name Time Method Change in generic health status measured by EuroQol-5 dimensions (EQ-5D) 0, 3, and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later The EQ-5D is a generic classification system used to characterize current health states of patients. It consists of 5 domains (mobility; self-care; usual activity; pain/discomfort; anxiety/depression) and a visual analogue scale (EQ-VAS). The domains have a scale from 1-3 and the VAS-scale from 0-100 in which higher values represent a better outcome.
Change in physical activity level assessed by measuring step count with accelerometry 0, 3, and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later Subjects will wear an activPAL accelerometer for 1 week to assess physical activity.
- Secondary Outcome Measures
Name Time Method Change in height 0-12 months Height will be measured in cm.
Change in Cohen's Perceived Stress Scale (PSS) 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. The PSS is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Change in cognitive function measured by the Neuropsychological test automated battery (CANTAB) 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. The investigators will use the Motor Screening Task, Reaction Time Task, Paired Associates Learning, Delayed Matching-to-Sample, Spatial Working Memory and Stop Signal Task. The higher the score on these tasks, the better the cognitive function.
Change in blood pressure after the socially evaluated cold pressure test 0-12 months. The SECPT asks the participant to immerse their right hand up to and including the writs into ice water for a maximum of 3 minutes. Blood pressure will be measured before and after the test.
Change in hair cortisol 0 and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. Cortisol level in hair is a biomarker of chronic stress.
Change in exercise performance by measuring the 6 minute walking distance 0-12 months. Subjects will be instructed to walk as fast as possible for 6 minutes. The distance walked during these 6 minutes will be measured.
Change in weight 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. Weight will be measured in kg.
Change in pain using the Visual Analogue Scale (VAS) 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. Pain will be assessed by the VAS range from 0-100, in which a higher score means more pain experience.
Change in intestinal fatty acid binding protein (blood) in rest 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. IFABP is a marker for intestinal integrity.
Change in Depression Anxiety Stress Scale 21 (DASS-21) 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. The DASS-21 measures 3 related states of depression, anxiety and stress. The DASS-21 consists of 21 negative emotional symptoms and subjects will be asked to extent to which have experienced each symptom over the past week, on a 4-point severity/frequency scale. The total score will range from 0-66 in which a higher score means more susceptibility to depression.
Change in Hospital and Anxiety Scale (HADS) 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. The HADS will allow the investigators to measure domain-specific quality of life. This is a 14-item instrument designed to detect the presence and severity of mild degrees of mood disorder, anxiety and depression in hospital and community setting and outside. Per scale (anxiety and depression) a maximum of 21 points can be scored, in which a higher score means worse outcome.
Change in cortisol in the saliva after the socially evaluated cold pressure test 0-12 months. The SECPT asks the participant to immerse their right hand up to and including the writs into ice water for a maximum of 3 minutes. Cortisol in the saliva will be measured before and after the test.
Change in muscle strength by measuring handgrip strength 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. Handgrip strength is measured in the dominant hand using a hydraulic grip strength dynamometer.
Change in body composition by performing Dual energy X-ray absorptiometry (DEXA-scan) 0-12 months. Using the DEXA-scan three compartments of the body composition (lean mass, fat mass, bone mass) will be measured.
Change in blood markers of systemic inflammation 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. Markers include high-sensitive C-reactive protein, procalcitonin, interleukin-6, interleukin-8 and leucocyte levels.
Change in blood markers of gut-muscle-brain cross-talk 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. Markers include tryptophan, kynurenine and kynurenic acid.
Change in sleep quality by the Pittsburgh Sleep Quality Index (PSQI) 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. The PSQI is a self-report questionnaire to assess sleep quality. It consists of 19 individual items, creating 7 components that produce one global score (0-21, in which higher scores indicate worse sleep quality).
Change in respiratory muscle strength by measuring the inspiratory and expiratory mouth pressure 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. The mouth pressure will be measured using the MicroRPM monitor.
Change in lower extremity performance by the short physical performance battery (SPPB) 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. Three manoeuvres will be performed: the balance test, the gait speed test and the chair stand test. Each individual can score 0-12 points in which a higher score means a better physical performance.
Change in blood markers of nutritional status 0-3 months; 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. Markers include vitamin E, vitamin D, poly unsaturated fatty acids, amino acids (tryptophan), and homocysteine.
Change in fatigue by using the checklist individual strength (CIS) 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later. The CIS is a 20-item self-report questionnaire that measures several aspects of fatigue: fatigue severity, concentration, motivation and physical activity. Individual scores can range from 20-140 in which higher scores mean fatigue problems.
Change in intestinal fatty acid binding protein (blood) after the 6MWT 0-12 months. IFABP is a marker for intestinal integrity.
Change in gut microbiome composition (optional) 0, 3 and 12 months. Several analysis will be performed after completion of the study. The exact markers of the microbiome will be determined.
Trial Locations
- Locations (1)
Maastricht University Medical Centre+ (MUMC+)
🇳🇱Maastricht, Limburg, Netherlands