RecruitingNot ApplicableNCT03807310

Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)

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

Sponsor

Maastricht University Medical Center

Enrollment

166 participants

Start Date

Feb 19, 2020

Study Type

INTERVENTIONAL

Conditions

Pulmonary Disease, Chronic Obstructive

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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.

Exclusion Criteria23

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.
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.