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Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)

ConditionPulmonary Disease, Chronic Obstructive
Trial statusActive, not recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

COPD patients with moderate to very severe disease stage according to GOLD criteria (i.e. GOLD stage II-IV);

Medically stable.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Targeted nutrient supplementation (Long-drink)

    Dietary supplement

    Once daily for at least 12 months

  • Placebo supplement

    Dietary supplement

    Once daily for at least 12 months

  • Counselling

    Behavioral

    Counselling on healthy lifestyle (in particular physical activity, smoking cessation) and weight management by motivational interviewing

Treatment groups

166 Participants
are divided into 3 treatment groups
Group A: Group Long-drinkExperimental treatment 2 interventions
Group B: Group PlaceboPlacebo comparator 2 interventions
Group C: Healthy control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in physical activity level assessed by measuring step count with accelerometry

Subjects will wear an activPAL accelerometer for 1 week to assess physical activity.

Time frame
0, 3, and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later
2

Change in generic health status measured by EuroQol-5 dimensions (EQ-5D)

The EQ-5D is a generic classification system used to characterize current health states of patients. It consists of 5 domains (mobility; self-care; usual activity; pain/discomfort; anxiety/depression) and a visual analogue scale (EQ-VAS). The domains have a scale from 1-3 and the VAS-scale from 0-100 in which higher values represent a better outcome.

Time frame
0, 3, and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later

Secondary outcomes

1

Change in cognitive function measured by the Neuropsychological test automated battery (CANTAB)

The investigators will use the Motor Screening Task, Reaction Time Task, Paired Associates Learning, Delayed Matching-to-Sample, Spatial Working Memory and Stop Signal Task. The higher the score on these tasks, the better the cognitive function.

Time frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
2

Change in Depression Anxiety Stress Scale 21 (DASS-21)

The DASS-21 measures 3 related states of depression, anxiety and stress. The DASS-21 consists of 21 negative emotional symptoms and subjects will be asked to extent to which have experienced each symptom over the past week, on a 4-point severity/frequency scale. The total score will range from 0-66 in which a higher score means more susceptibility to depression.

Time frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
3

Change in Hospital and Anxiety Scale (HADS)

The HADS will allow the investigators to measure domain-specific quality of life. This is a 14-item instrument designed to detect the presence and severity of mild degrees of mood disorder, anxiety and depression in hospital and community setting and outside. Per scale (anxiety and depression) a maximum of 21 points can be scored, in which a higher score means worse outcome.

Time frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
4

Change in Cohen's Perceived Stress Scale (PSS)

The PSS is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

Time frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.

Other outcomes

1

Change in forced expiratory volume in 1 second

Measured by spirometry within 3 previous months.

Time frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
2

Change in forced vital capacity

Measured by spirometry within 3 previous months.

Time frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
3

Total lung capacity

Measured by body plethysmography within 3 previous months

Time frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.
4

Functional residual capacity

Measured by body plethysmography within 3 previous months

Time frame
0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maastricht University Medical Center

Lead sponsor

Nutricia Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: