Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03807310

Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)

Led by Maastricht University Medical Center · Updated on 2025-01-14

166

Participants Needed

1

Research Sites

332 weeks

Total Duration

On this page

Sponsors

M

Maastricht University Medical Center

Lead Sponsor

N

Nutricia Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Maastricht University Medical Centre+ (MUMC+)

Maastricht, Limburg, Netherlands, 6202 AZ

Actively Recruiting

Loading map...

Research Team

R

Rosanne Beijers, Dr

CONTACT

H

Harry Gosker, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here