Nutrient supplementation for improving health in COPD patients

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

This study is testing whether giving extra nutrients to people with COPD can help them feel better, move more, and improve their overall health after being in the hospital.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Maastricht University Medical Center (Academic / other)
• Locations: 1 site (Maastricht, Limburg)
• Trial ID: NCT03807310 on ClinicalTrials.gov

What this trial studies

This trial investigates the effects of targeted nutrient supplementation on physical activity levels and overall health status in patients with Chronic Obstructive Pulmonary Disease (COPD). It is a randomized, placebo-controlled, double-blind study that aims to assess not only physical recovery after hospitalization for COPD exacerbations but also mental health, physical performance, and gut health. The study will compare the gut microbiome of COPD patients with that of healthy controls to understand the broader implications of nutrient supplementation on health.

Who should consider this trial

Good fit: Ideal candidates are adults with moderate to very severe COPD who are medically stable.

Not a fit: Patients with terminal illnesses or those who have had recent hospital admissions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the quality of life and recovery outcomes for patients with COPD through improved nutritional support.

How similar studies have performed: Other studies have shown promising results with nutrient supplementation in chronic diseases, suggesting potential for success in this approach.

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.

Where this trial is running

Maastricht, Limburg

• Maastricht University Medical Centre+ (MUMC+) — Maastricht, Limburg, Netherlands (Recruiting)

Study contacts

• Study coordinator: Rosanne Beijers, Dr

Conditions Pulmonary Disease, Chronic Obstructive; COPD; nutrient supplementation; Physical activity; Health related quality of life