To investigate the efficacy of targeted nutrient supplementation on daily physical activity level as well as generic health status in patients with moderate to very severe COPD. Additionally, we aim to disentangle the relative effect of targeted…
ID
Source
Brief title
Condition
- Muscle disorders
- Cognitive and attention disorders and disturbances
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Physical activity level
- General health status
Secondary outcome
- Mental health
- Physical performance
- Blood markers
- Patient related outcomes
- Gut health
Background summary
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. We
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 moderate to very severe COPD patients.
Study objective
To investigate the efficacy of targeted nutrient supplementation on daily
physical activity level as well as generic health status in patients with
moderate to very severe COPD. Additionally, we aim to disentangle the relative
effect of targeted nutrient supplementation on the recovery after
hospitalization for a COPD exacerbation. Furthermore, we want to investigate if
the gut microbiome composition in patients with COPD is disrupted in comparison
with a reference group at baseline and if the composition improves after 3
months of nutritional intervention (in COPD patients only).
Study design
Randomized, placebo-controlled, double-blind trial comparing two groups of 83
patients.
Intervention
The intervention group will receive 1 supplement per day for at least 12
months. The main components of the supplement are vitamin D, tryptophan,
long-chain polyunsaturated fatty acids (PUFA), and fibres. The control group
will receive an isocaloric placebo for at least 12 months. In addition, both
groups will receive counselling on medical adherence, healthy lifestyle and
management of weight loss over the course of the study.
Study burden and risks
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. We expect no risk of the nutrient supplementation.
P Debyelaan 25
Maastricht 6202 AZ
NL
P Debyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
COPD patients NUTRECOVER trial:
- COPD patients with moderate to very severe disease stage according to GOLD
criteria (i.e. GOLD stage II-IV);
- Medically stable in the opinion of the investigator.
Reference group microbiome study:
- Lung function: FEV1/FVC > 0.7
- Medically stable in the opinion of the investigator.
Exclusion criteria
COPD patients NUTRECOVER trial:
Exclusion criteria indicated with an asterisk (*) are also exclusion criteria
for the subjects in the reference group for the microbiome study.
- Age <18 years;*
- Allergy or intolerance to components of the study product;
- 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);*
- COPD patients with temporary oral steroid or antibiotics use due to a COPD
exacerbation in the last 4 weeks or subjects in the reference group with
antibiotics use for any reason 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
gastro-intestinal function (e.g. short bowel syndrome, inflammatory bowel
disease, gastric ulcers, gastritis, (gastro)-enteritis, GI cancer as judged by
the investigator;*
-Subjects in the reference group in the microbiome study: diagnosis of any
chronic lung disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03807310 |
| CCMO | NL66543.068.18 |