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Targeted Nutrient Supplement in COPD (NUTRECOVER-trial) (NUTRECOVER)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Targeted nutrient supplementation (Long-drink)
Placebo supplement
Counselling
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, nutrient supplementation, Physical activity, Health related quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria COPD Patients:

  • COPD patients with moderate to very severe disease stage according to GOLD criteria (i.e. GOLD stage II-IV);
  • Medically stable.

Exclusion Criteria COPD Patients:

  • Age <18 years;
  • Allergy or intolerance to components of the study product;
  • Not willing or not able to quit vitamin D or fatty acid supplement intake;
  • Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. leg amputation) or patients suffering from other acute or unstable chronic diseases that will compromise the study outcome (e.g. active cancer requiring treatment);
  • Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study;
  • Patients with terminal illness;
  • Recent hospital admission (<4 weeks prior to the start of the study);
  • Temporary oral steroid or antibiotics use due to a COPD exacerbation in the last 4 weeks;
  • Lung malignancy in the previous 5 years;
  • Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia) in the medical records;
  • Recent diagnosis of cerebral conditions (<1 year e.g. cerebral infarction, hemorrhage, brain tumors, transient ischemic attack) in the medical records;
  • Any medical condition that significantly interferes with digestion and/or gastrointestinal function (e.g. short bowel syndrome, inflammatory bowel disease, gastric ulcers, gastritis, (gastro)-enteritis, GI-cancer) as judged by the investigator.

Inclusion Criteria Healthy Controls

  • Forced expiratory volume in 1 second/Forced vital capacity > 0.7;
  • Medically stable.

Exclusion Criteria Healthy Controls

  • Age <18 years;
  • Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. leg amputation) or patients suffering from other acute or unstable chronic diseases that will compromise the study outcome (e.g. active cancer requiring treatment);
  • Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study;
  • Patients with terminal illness;
  • Recent hospital admission (<4 weeks prior to the start of the study);
  • Temporary antibiotics use in the last 4 weeks;
  • Lung malignancy in the previous 5 years;
  • Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia) in the medical records;
  • Recent diagnosis of cerebral conditions (<1 year e.g. cerebral infarction, hemorrhage, brain tumors, transient ischemic attack) in the medical records;
  • Any medical condition that significantly interferes with digestion and/or gastrointestinal function (e.g. short bowel syndrome, inflammatory bowel disease, gastric ulcers, gastritis, (gastro)-enteritis, GI-cancer) as judged by the investigator.
  • Diagnosis of any chronic lung disease.

Sites / Locations

  • Maastricht University Medical Centre+ (MUMC+)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Group Long-drink

Group Placebo

Healthy control group

Arm Description

83 COPD patients will receive: Targeted nutrient supplementation (Long-drink) once daily Counselling once monthly

83 COPD patients will receive: Isocaloric placebo supplement once daily Counselling once monthly

30 healthy controls will be included for baseline comparison of the microbiome composition. These healthy controls will only perform a subset of baseline measurements and will not be included in the intervention.

Outcomes

Primary Outcome Measures

Change in physical activity level assessed by measuring step count with accelerometry
Subjects will wear an activPAL accelerometer for 1 week to assess physical activity.
Change in generic health status measured by EuroQol-5 dimensions (EQ-5D)
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.

Secondary Outcome Measures

Change in cognitive function measured by the Neuropsychological test automated battery (CANTAB)
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 Depression Anxiety Stress Scale 21 (DASS-21)
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)
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 Cohen's Perceived Stress Scale (PSS)
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 blood pressure after the socially evaluated cold pressure test
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 cortisol in the saliva after the socially evaluated cold pressure test
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 hair cortisol
Cortisol level in hair is a biomarker of chronic stress.
Change in lower extremity performance by the short physical performance battery (SPPB)
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 muscle strength by measuring handgrip strength
Handgrip strength is measured in the dominant hand using a hydraulic grip strength dynamometer.
Change in respiratory muscle strength by measuring the inspiratory and expiratory mouth pressure
The mouth pressure will be measured using the MicroRPM monitor.
Change in exercise performance by measuring the 6 minute walking distance
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 body composition by performing Dual energy X-ray absorptiometry (DEXA-scan)
Using the DEXA-scan three compartments of the body composition (lean mass, fat mass, bone mass) will be measured.
Change in weight
Weight will be measured in kg.
Change in height
Height will be measured in cm.
Change in blood markers of systemic inflammation
Markers include high-sensitive C-reactive protein, procalcitonin, interleukin-6, interleukin-8 and leucocyte levels.
Change in blood markers of nutritional status
Markers include vitamin E, vitamin D, poly unsaturated fatty acids, amino acids (tryptophan), and homocysteine.
Change in blood markers of gut-muscle-brain cross-talk
Markers include tryptophan, kynurenine and kynurenic acid.
Change in fatigue by using the checklist individual strength (CIS)
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 pain using the Visual Analogue Scale (VAS)
Pain will be assessed by the VAS range from 0-100, in which a higher score means more pain experience.
Change in sleep quality by the Pittsburgh Sleep Quality Index (PSQI)
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 intestinal fatty acid binding protein (blood) in rest
IFABP is a marker for intestinal integrity.
Change in intestinal fatty acid binding protein (blood) after the 6MWT
IFABP is a marker for intestinal integrity.
Change in gut microbiome composition (optional)
Several analysis will be performed after completion of the study. The exact markers of the microbiome will be determined.

Full Information

First Posted
January 9, 2019
Last Updated
March 14, 2023
Sponsor
Maastricht University Medical Center
Collaborators
Nutricia Research
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1. Study Identification

Unique Protocol Identification Number
NCT03807310
Brief Title
Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)
Acronym
NUTRECOVER
Official Title
The Effect of Targeted Nutrient Supplementation on Physical Activity and Healthy Related Quality of Life in COPD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Nutricia Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD, nutrient supplementation, Physical activity, Health related quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Next to the 166 COPD patients that receive the nutritional supplement, a subgroup of 30 healthy controls will be included for baseline comparison of the microbiome composition. These healthy controls will not be included in the intervention arm.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Long-drink
Arm Type
Experimental
Arm Description
83 COPD patients will receive: Targeted nutrient supplementation (Long-drink) once daily Counselling once monthly
Arm Title
Group Placebo
Arm Type
Placebo Comparator
Arm Description
83 COPD patients will receive: Isocaloric placebo supplement once daily Counselling once monthly
Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
30 healthy controls will be included for baseline comparison of the microbiome composition. These healthy controls will only perform a subset of baseline measurements and will not be included in the intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Targeted nutrient supplementation (Long-drink)
Other Intervention Name(s)
Nutritional supplementation, Dietary supplement, Nutritional supplement, Food supplement
Intervention Description
Once daily for at least 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplement
Other Intervention Name(s)
Non-active supplement
Intervention Description
Once daily for at least 12 months
Intervention Type
Behavioral
Intervention Name(s)
Counselling
Other Intervention Name(s)
Motivational interviewing
Intervention Description
Counselling on healthy lifestyle (in particular physical activity, smoking cessation) and weight management by motivational interviewing
Primary Outcome Measure Information:
Title
Change in physical activity level assessed by measuring step count with accelerometry
Description
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
Title
Change in generic health status measured by EuroQol-5 dimensions (EQ-5D)
Description
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, 3, and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later
Secondary Outcome Measure Information:
Title
Change in cognitive function measured by the Neuropsychological test automated battery (CANTAB)
Description
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.
Title
Change in Depression Anxiety Stress Scale 21 (DASS-21)
Description
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.
Title
Change in Hospital and Anxiety Scale (HADS)
Description
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.
Title
Change in Cohen's Perceived Stress Scale (PSS)
Description
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; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Title
Change in blood pressure after the socially evaluated cold pressure test
Description
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.
Title
Change in cortisol in the saliva after the socially evaluated cold pressure test
Description
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
0-12 months.
Title
Change in hair cortisol
Description
Cortisol level in hair is a biomarker of chronic stress.
Time Frame
0 and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Title
Change in lower extremity performance by the short physical performance battery (SPPB)
Description
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.
Title
Change in muscle strength by measuring handgrip strength
Description
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.
Title
Change in respiratory muscle strength by measuring the inspiratory and expiratory mouth pressure
Description
The mouth pressure will be measured using the MicroRPM monitor.
Time Frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Title
Change in exercise performance by measuring the 6 minute walking distance
Description
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.
Title
Change in body composition by performing Dual energy X-ray absorptiometry (DEXA-scan)
Description
Using the DEXA-scan three compartments of the body composition (lean mass, fat mass, bone mass) will be measured.
Time Frame
0-12 months.
Title
Change in weight
Description
Weight will be measured in kg.
Time Frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Title
Change in height
Description
Height will be measured in cm.
Time Frame
0-12 months
Title
Change in blood markers of systemic inflammation
Description
Markers include high-sensitive C-reactive protein, procalcitonin, interleukin-6, interleukin-8 and leucocyte levels.
Time Frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Title
Change in blood markers of nutritional status
Description
Markers include vitamin E, vitamin D, poly unsaturated fatty acids, amino acids (tryptophan), and homocysteine.
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.
Title
Change in blood markers of gut-muscle-brain cross-talk
Description
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.
Title
Change in fatigue by using the checklist individual strength (CIS)
Description
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.
Title
Change in pain using the Visual Analogue Scale (VAS)
Description
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.
Title
Change in sleep quality by the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Title
Change in intestinal fatty acid binding protein (blood) in rest
Description
IFABP is a marker for intestinal integrity.
Time Frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Title
Change in intestinal fatty acid binding protein (blood) after the 6MWT
Description
IFABP is a marker for intestinal integrity.
Time Frame
0-12 months.
Title
Change in gut microbiome composition (optional)
Description
Several analysis will be performed after completion of the study. The exact markers of the microbiome will be determined.
Time Frame
0, 3 and 12 months.
Other Pre-specified Outcome Measures:
Title
Change in forced expiratory volume in 1 second
Description
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.
Title
Change in forced vital capacity
Description
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.
Title
Total lung capacity
Description
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.
Title
Functional residual capacity
Description
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.
Title
Change in diffusion capacity
Description
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.
Title
Change in the global impacts of COPD on health status using the COPD assessment test (CAT)
Description
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.
Title
Change in health status using the Clinical COPD questionnaire (CCQ)
Description
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.
Title
Change in breathlessness using the medical research council (MRC-scale)
Description
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.
Title
Change in medication use by self-report
Description
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.
Title
Change in medical history will be assessed from medical records
Description
Comorbidities will be extracted from the medical history
Time Frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Title
Change in food intake
Description
3-day 24h food diary
Time Frame
0, 3 and 12-14 months
Title
Blood gases
Description
retrieved from medical records
Time Frame
in case of hospitalization for COPD exacerbation within one week after discharge
Title
Type of infection
Description
Viral or bacterial infection based on medical records
Time Frame
in case of hospitalization for COPD exacerbation within one week after discharge
Title
Number of patients died
Description
from the medical records
Time Frame
from beginning of the study till 1 year after study completion
Title
Number of patients readmitted for a COPD exacerbation
Description
from the medical records
Time Frame
from beginning of the study till 1 year after study completion
Title
Difference in gut microbiome composition between healthy controls and COPD patients
Description
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
Title
Difference in lung function between healthy controls and COPD patients
Description
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
Title
Difference in blood systemic inflammation between healthy controls and COPD patients
Description
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
Title
Difference in food intake between healthy controls and COPD patients
Description
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
Title
Difference in medication use between healthy controls and COPD patients
Description
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.
Time Frame
Baseline asssment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria COPD Patients: COPD patients with moderate to very severe disease stage according to GOLD criteria (i.e. GOLD stage II-IV); Medically stable. Exclusion Criteria COPD Patients: Age <18 years; Allergy or intolerance to components of the study product; Not willing or not able to quit vitamin D or fatty acid supplement intake; Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. leg amputation) or patients suffering from other acute or unstable chronic diseases that will compromise the study outcome (e.g. active cancer requiring treatment); Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study; Patients with terminal illness; Recent hospital admission (<4 weeks prior to the start of the study); Temporary oral steroid or antibiotics use due to a COPD exacerbation in the last 4 weeks; Lung malignancy in the previous 5 years; Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia) in the medical records; Recent diagnosis of cerebral conditions (<1 year e.g. cerebral infarction, hemorrhage, brain tumors, transient ischemic attack) in the medical records; Any medical condition that significantly interferes with digestion and/or gastrointestinal function (e.g. short bowel syndrome, inflammatory bowel disease, gastric ulcers, gastritis, (gastro)-enteritis, GI-cancer) as judged by the investigator. Inclusion Criteria Healthy Controls Forced expiratory volume in 1 second/Forced vital capacity > 0.7; Medically stable. Exclusion Criteria Healthy Controls Age <18 years; Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. leg amputation) or patients suffering from other acute or unstable chronic diseases that will compromise the study outcome (e.g. active cancer requiring treatment); Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study; Patients with terminal illness; Recent hospital admission (<4 weeks prior to the start of the study); Temporary antibiotics use in the last 4 weeks; Lung malignancy in the previous 5 years; Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia) in the medical records; Recent diagnosis of cerebral conditions (<1 year e.g. cerebral infarction, hemorrhage, brain tumors, transient ischemic attack) in the medical records; Any medical condition that significantly interferes with digestion and/or gastrointestinal function (e.g. short bowel syndrome, inflammatory bowel disease, gastric ulcers, gastritis, (gastro)-enteritis, GI-cancer) as judged by the investigator. Diagnosis of any chronic lung disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosanne Beijers, Dr
Phone
+31433882990
Email
r.beijers@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Harry Gosker, Dr
Phone
+31433884298
Email
h.gosker@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Schols, Prof. dr.
Organizational Affiliation
Maastricht UMC+ / NUTRIM, Department of Respiratory Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Maastricht University Medical Centre+ (MUMC+)
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosanne Beijers, PhD
Email
r.beijers@maastrichtuniversity.nl

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Deidentified data will only be shared based on a reasonable request.
Citations:
PubMed Identifier
35296491
Citation
Beijers RJ, van Iersel LEJ, Schuurman LT, Hageman RJJ, Simons SO, van Helvoort A, Gosker HR, Schols AM. Effect of targeted nutrient supplementation on physical activity and health-related quality of life in COPD: study protocol for the randomised controlled NUTRECOVER trial. BMJ Open. 2022 Mar 16;12(3):e059252. doi: 10.1136/bmjopen-2021-059252.
Results Reference
derived

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Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)

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