Pulmonary Disease, Chronic ObstructiveNUTRECOVERNCT03807310

Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)

A study testing Targeted nutrient supplementation (Long-drink) and Counselling in people with Pulmonary Disease, Chronic Obstructive, run by Maastricht University Medical Center at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Targeted nutrient supplementation (Long-drink) and Counselling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 166 participants
Where: 1 siteNetherlands
Study dates: 19 Feb 2020to Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

COPD patients with moderate to very severe disease stage according to GOLD criteria (i.e. GOLD stage II-IV);
Medically stable.
Forced expiratory volume in 1 second/Forced vital capacity > 0.7;
Medically stable.

Who cannot join

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;

Show all 23Show fewer

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.
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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Maastricht University Medical Centre+ (MUMC+)
Maastricht, Limburg, 6202 AZ

Other trials in Netherlands

About this study

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

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.

Read the 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
Being tested: Targeted nutrient supplementation (Long-drink), Placebo supplement, Counselling
Keywords: COPD, nutrient supplementation, Physical activity, Health related quality of life
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Targeted nutrient supplementation (Long-drink)Dietary supplement
Also called Nutritional supplementation, Dietary supplement, Nutritional supplement, Food supplement
Once daily for at least 12 months
Placebo supplementDietary supplement
Also called Non-active supplement
Once daily for at least 12 months
CounsellingBehavioural
Also called Motivational interviewing
Counselling on healthy lifestyle (in particular physical activity, smoking cessation) and weight management by motivational interviewing

Study groups in NCT03807310
Study group	Role	What they receive
Group Long-drink	Experimental	83 COPD patients will receive: * Targeted nutrient supplementation (Long-drink) once daily * Counselling once monthly Receives: Dietary Supplement: Targeted nutrient supplementation (Long-drink); Behavioral: Counselling
Group Placebo	Placebo comparator	83 COPD patients will receive: * Isocaloric placebo supplement once daily * Counselling once monthly Receives: Dietary Supplement: Placebo supplement; Behavioral: Counselling
Healthy control group	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 0, 3, and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later
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.
Measured: 0, 3, and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later

Secondary outcomes (23)

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.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
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.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
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.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
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.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
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.
Measured: 0-12 months.
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.
Measured: 0-12 months.
Change in hair cortisol
Cortisol level in hair is a biomarker of chronic stress.
Measured: 0 and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
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.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in muscle strength by measuring handgrip strength
Handgrip strength is measured in the dominant hand using a hydraulic grip strength dynamometer.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in respiratory muscle strength by measuring the inspiratory and expiratory mouth pressure
The mouth pressure will be measured using the MicroRPM monitor.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
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.
Measured: 0-12 months.
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.
Measured: 0-12 months.
Change in weight
Weight will be measured in kg.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in height
Height will be measured in cm.
Measured: 0-12 months
Change in blood markers of systemic inflammation
Markers include high-sensitive C-reactive protein, procalcitonin, interleukin-6, interleukin-8 and leucocyte levels.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in blood markers of nutritional status
Markers include vitamin E, vitamin D, poly unsaturated fatty acids, amino acids (tryptophan), and homocysteine.
Measured: 0-3 months; 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in blood markers of gut-muscle-brain cross-talk
Markers include tryptophan, kynurenine and kynurenic acid.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
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.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
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.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
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).
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in intestinal fatty acid binding protein (blood) in rest
IFABP is a marker for intestinal integrity.
Measured: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in intestinal fatty acid binding protein (blood) after the 6MWT
IFABP is a marker for intestinal integrity.
Measured: 0-12 months.
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.
Measured: 0, 3 and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Feb 2020Dec 2027

First posted16 Jan 2019
Study start19 Feb 2020
Primary completionDec 2026 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 166 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03807310
Sponsor's protocol ID: METC18-011
Other IDs: 10.2.16.119
Acronym: NUTRECOVER
Status last verified: Oct 2026
First submitted: 9 Jan 2019
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Deidentified data will only be shared based on a reasonable request.

Publications

Born CDC, Beijers RJHCG, van Iersel LEJ, Muijrers IHMJE, Schuurman LT, Gerards SMPL, Simons SO, Gosker HR, van Helvoort A, Schols AMWJ, Crutzen R. Assessing Lifestyle Goal Setting in Patients with COPD. Int J Chron Obstruct Pulmon Dis. 2026 Mar 31;21:579191. doi: 10.2147/COPD.S579191. eCollection 2026.
PubMed 41939921
van Iersel LEJ, Beijers RJHCG, Simons SO, Schuurman LT, Shetty SA, Roeselers G, van Helvoort A, Schols AMWJ, Gosker HR. Characterizing gut microbial dysbiosis and exploring the effect of prebiotic fiber supplementation in patients with COPD. Eur J Nutr. 2025 Jun 7;64(5):210. doi: 10.1007/s00394-025-03733-7.
PubMed 40481968
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.
PubMed 35296491

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Targeted Nutrient Supplementation on Physical Activity and Healthy Related Quality of Life in COPD
ClinicalTrials.gov ID: NCT03807310
Acronym / sponsor ID: NUTRECOVER / METC18-011
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD, nutrient supplementation, Physical activity, Health related quality of life
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 166 participants (estimated)
Lead sponsor: Maastricht University Medical CenterUniversity, hospital or other
Collaborators: Nutricia Research
Study start: 19 Feb 2020 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 16 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design: Randomized, placebo-controlled, double-blind trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3
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.

Arm	Type	Receives
Group Long-drink	Experimental	Dietary Supplement: Targeted nutrient supplementation (Long-drink), Behavioral: Counselling83 COPD patients will receive: * Targeted nutrient supplementation (Long-drink) once daily * Counselling once monthly
Group Placebo	Placebo comparator	Dietary Supplement: Placebo supplement, Behavioral: Counselling83 COPD patients will receive: * Isocaloric placebo supplement once daily * Counselling once monthly
Healthy control group	No intervention	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

COPD patients with moderate to very severe disease stage according to GOLD criteria (i.e. GOLD stage II-IV);
Medically stable.
Forced expiratory volume in 1 second/Forced vital capacity > 0.7;
Medically stable.

Key exclusion criteria (23 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Targeted nutrient supplementation (Long-drink)Also: Nutritional supplementation, Dietary supplement, Nutritional supplement, Food supplementOnce daily for at least 12 months	Dietary supplement	Group Long-drink
Placebo supplementAlso: Non-active supplementOnce daily for at least 12 months	Dietary supplement	Group Placebo
CounsellingAlso: Motivational interviewingCounselling on healthy lifestyle (in particular physical activity, smoking cessation) and weight management by motivational interviewing	Behavioural	Group Long-drink, Group Placebo

Primary outcome

Change in physical activity level assessed by measuring step count with accelerometry
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.
Change in generic health status measured by EuroQol-5 dimensions (EQ-5D)
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.

23 secondary outcomes

Change in cognitive function measured by the Neuropsychological test automated battery (CANTAB)
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in Depression Anxiety Stress Scale 21 (DASS-21)
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in Hospital and Anxiety Scale (HADS)
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in Cohen's Perceived Stress Scale (PSS)
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in blood pressure after the socially evaluated cold pressure test
Time frame: 0-12 months.
Change in cortisol in the saliva after the socially evaluated cold pressure test
Time frame: 0-12 months.
Change in hair cortisol
Time frame: 0 and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in lower extremity performance by the short physical performance battery (SPPB)
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in muscle strength by measuring handgrip strength
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in respiratory muscle strength by measuring the inspiratory and expiratory mouth pressure
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in exercise performance by measuring the 6 minute walking distance
Time frame: 0-12 months.
Change in body composition by performing Dual energy X-ray absorptiometry (DEXA-scan)
Time frame: 0-12 months.
Change in weight
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in height
Time frame: 0-12 months
Change in blood markers of systemic inflammation
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in blood markers of nutritional status
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.
Change in blood markers of gut-muscle-brain cross-talk
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in fatigue by using the checklist individual strength (CIS)
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in pain using the Visual Analogue Scale (VAS)
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in sleep quality by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in intestinal fatty acid binding protein (blood) in rest
Time frame: 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
Change in intestinal fatty acid binding protein (blood) after the 6MWT
Time frame: 0-12 months.
Change in gut microbiome composition (optional)
Time frame: 0, 3 and 12 months.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Derived from this study: PubMed 41939921Born CDC, Beijers RJHCG, van Iersel LEJ, Muijrers IHMJE, Schuurman LT, Gerards SMPL, Simons SO, Gosker HR, van Helvoort A, Schols AMWJ, Crutzen R. Assessing Lifestyle Goal Setting in Patients with COPD. Int J Chron Obstruct Pulmon Dis. 2026 Mar 31;21:579191. doi: 10.2147/COPD.S579191. eCollection 2026.
Derived from this study: PubMed 40481968van Iersel LEJ, Beijers RJHCG, Simons SO, Schuurman LT, Shetty SA, Roeselers G, van Helvoort A, Schols AMWJ, Gosker HR. Characterizing gut microbial dysbiosis and exploring the effect of prebiotic fiber supplementation in patients with COPD. Eur J Nutr. 2025 Jun 7;64(5):210. doi: 10.1007/s00394-025-03733-7.
Derived from this study: PubMed 35296491Beijers 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.
Individual participant dataSharing planned: No. Deidentified data will only be shared based on a reasonable request.

Related trials for Pulmonary Disease, Chronic Obstructive

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Annemie Schols, Prof. dr. study director

Maastricht UMC+ / NUTRIM, Department of Respiratory Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in physical activity level assessed by measuring step count with accelerometry (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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03807310, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.