Characterizing gut microbial dysbiosis and exploring the effect of prebiotic fiber supplementation in patients with COPD.
Lieke E J van Iersel, Rosanne J H C G Beijers, Sami O Simons...
https://pubmed.ncbi.nlm.nih.gov/40481968/Actively Recruiting
Led by Maastricht University Medical Center · Updated on 2025-01-14
166
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effects of targeted nutrient supplementation on daily physical activity levels and overall health status in patients with chronic obstructive pulmonary disease COPD. The study also aims to assess how this supplementation influences recovery after hospitalization for a COPD exacerbation. Secondary goals include examining impacts on mental health, physical performance, blood markers, patient-reported outcomes, and gut health, as well as comparing the gut microbiome of COPD patients to healthy controls. Participants include COPD patients randomly assigned to receive either a daily targeted nutrient supplement in a long-drink form or an isocaloric placebo, both accompanied by monthly healthy lifestyle counseling focusing on physical activity, smoking cessation, and weight management. The intervention lasts at least 12 months. Additionally, healthy controls will undergo baseline measurements for microbiome comparison but will not receive supplements or counseling. During the study, participants will have their physical activity monitored through step counts and complete health questionnaires at the beginning, three months, and between twelve to fourteen months, with additional assessments after any COPD-related hospitalizations. Researchers will perform a range of tests including cognitive function assessments, mental health scales, physical performance tests, blood sampling, body composition scans, and gut microbiome analysis. These evaluations help measure changes in health and recovery over time while monitoring safety and adherence.
CONDITIONS
Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)
R
Rosanne Beijers, Dr
H
Harry Gosker, Dr
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Maastricht University Medical Center
Lead Sponsor
Nutricia Research
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 12 months
Participants with COPD will take either the targeted nutrient supplement or placebo daily and receive counselling on healthy lifestyle and weight management once monthly.
Monthly visits for counselling and assessments at baseline, 3 months, and 12-14 months
Duration - Up to 12-14 months with additional assessments after hospitalization if applicable
Participants are monitored for changes in physical activity, health status, cognitive function, and other health measures during and after treatment, including assessments following any hospitalization for COPD exacerbation.
Visits at 0, 3, and 12-14 months and additional visits within one week after discharge and 4 weeks later if hospitalized
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Lieke E J van Iersel, Rosanne J H C G Beijers, Sami O Simons...
https://pubmed.ncbi.nlm.nih.gov/40481968/Rosanne Jhcg Beijers, Lieke E J van Iersel, Lisanne T Schuurman...
https://pubmed.ncbi.nlm.nih.gov/35296491/Charlotte D C Born, Rosanne J H C G Beijers, Lieke E J van Iersel...
https://pubmed.ncbi.nlm.nih.gov/41939921/Maastricht University Medical Center
Lead Sponsor
Nutricia Research
Collaborating Sponsor