Maastricht University Medical Centre+ (MUMC+)
Maastricht, Limburg, 6202 AZ, Netherlands
Location status: Recruiting
NCT Number: NCT03807310
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Maastricht, Limburg, 6202 AZ, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
COPD Patients:
Exclusion criteria
COPD Patients:
Inclusion criteria
Healthy Controls
Exclusion criteria
Healthy Controls
Once daily for at least 12 months
Other names: Nutritional supplementation, Dietary supplement, Nutritional supplement, Food supplement
Once daily for at least 12 months
Other names: Non-active supplement
Counselling on healthy lifestyle (in particular physical activity, smoking cessation) and weight management by motivational interviewing
Other names: Motivational interviewing
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0-12 months.
Using the DEXA-scan three compartments of the body composition (lean mass, fat mass, bone mass) will be measured.
Time frame: 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.
Time frame: 0-12 months
Height will be measured in cm.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 0-12 months.
IFABP is a marker for intestinal integrity.
Time frame: 0, 3 and 12 months.
Several analysis will be performed after completion of the study. The exact markers of the microbiome will be determined.
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Measured by spirometry within 3 previous months.
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Measured by spirometry within 3 previous months.
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Measured by body plethysmography within 3 previous months
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Measured by body plethysmography within 3 previous months
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
measured within 3 previous months
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
The CAT score ranges from 0-40, in which a higher score means worse outcome.
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
The CCQ is a 10-item questionnaire and individual scores range from 0-6 in which a higher score means worse health status
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
The MRC-scale ranges from 0-5 in which a higher score means more breathlessness.
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
All medications used by participants will be reported to determine difference in medication use between groups.
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Comorbidities will be extracted from the medical history
Time frame: 0, 3 and 12-14 months
3-day 24h food diary
Time frame: in case of hospitalization for COPD exacerbation within one week after discharge
retrieved from medical records
Time frame: in case of hospitalization for COPD exacerbation within one week after discharge
Viral or bacterial infection based on medical records
Time frame: from beginning of the study till 1 year after study completion
from the medical records
Time frame: from beginning of the study till 1 year after study completion
from the medical records
Time frame: Baseline asssment
To determine difference between COPD patients and healthy controls in gut microbiome composition, 30 healthy controls will sample stool at baseline which will be compared to a subgroup of 30 COPD patients.
Time frame: Baseline asssment
To ascertain that healthy controls have no obstructive lung disease, a baseline lung function measurement will be performed in the 30 healthy controls and compared to a subgroup of 30 COPD patients.
Time frame: Baseline asssment
To determine difference between COPD patients and healthy controls in systemic inflammation, blood samples will be obtained at baseline from 30 healthy controls and compared to a subgroup of 30 COPD patients.
Time frame: Baseline asssment
To determine difference between COPD patients and healthy controls in food intake, a 3-day 24h food diary will be obtained at baseline from 30 healthy controls and compared to a subgroup of 30 COPD patients.
Time frame: Baseline asssment
To determine difference between COPD patients and healthy controls in medication use, all medications used by the 30 healthy controls will be reported at baseline and compared to a subgroup of 30 COPD patients.
Contact information is provided by the study sponsor or research team.
Harry Gosker, Dr
CONTACT
Rosanne Beijers, Dr
CONTACT
Maastricht University Medical Center
Other
The Effect of Targeted Nutrient Supplementation on Physical Activity and Healthy Related Quality of Life in COPD
Acronym: NUTRECOVER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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