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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Maastricht University Medical Centre+ (MUMC+)
RECRUITING
Maastricht
Contact Information
Primary
Rosanne Beijers, Dr
r.beijers@maastrichtuniversity.nl
+31433882990
Backup
Harry Gosker, Dr
h.gosker@maastrichtuniversity.nl
+31433884298
Time Frame
Start Date: 2020-02-19
Estimated Completion Date: 2026-07
Participants
Target number of participants: 166
Treatments
Experimental: Group Long-drink
83 COPD patients will receive:~* Targeted nutrient supplementation (Long-drink) once daily~* Counselling once monthly
Placebo_comparator: Group Placebo
83 COPD patients will receive:~* Isocaloric placebo supplement once daily~* Counselling once monthly
No_intervention: Healthy control group
30 healthy controls will be included for baseline comparison of the microbiome composition. These healthy controls will only perform a subset of baseline measurements and will not be included in the intervention.
Related Therapeutic Areas
Chronic Obstructive Pulmonary Disease (COPD)
Sponsors
Collaborators: Nutricia Research
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov

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