Targeted Nutrient Supplement in COPD (NUTRECOVER-trial)

NCT03807310 | Recruiting DMC

• 2 other identifiers: METC18-01110.2.16.119
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; nutrient supplementation; Physical activity; Health related quality of life

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  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 (23)

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

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

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

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

• Change in Hospital and Anxiety Scale (HADS)

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

• Change in Cohen's Perceived Stress Scale (PSS)

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

• Change in blood pressure after the socially evaluated cold pressure test

  0-12 months.

Other Outcomes (20)

• Change in forced expiratory volume in 1 second

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

• Change in forced vital capacity

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

• Total lung capacity

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

Study Arms (3)

Group Long-drink

EXPERIMENTAL

83 COPD patients will receive: * Targeted nutrient supplementation (Long-drink) once daily * Counselling once monthly

Dietary Supplement: Targeted nutrient supplementation (Long-drink); Behavioral: Counselling

Group Placebo

PLACEBO COMPARATOR

83 COPD patients will receive: * Isocaloric placebo supplement once daily * Counselling once monthly

Dietary Supplement: Placebo supplement; Behavioral: Counselling

Healthy control group

NO INTERVENTION

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.

Interventions

Targeted nutrient supplementation (Long-drink) DIETARY_SUPPLEMENT

Once daily for at least 12 months

Also known as: Nutritional supplementation, Dietary supplement, Nutritional supplement, Food supplement

Group Long-drink

Placebo supplement DIETARY_SUPPLEMENT

Once daily for at least 12 months

Also known as: Non-active supplement

Group Placebo

Counselling BEHAVIORAL

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

Also known as: Motivational interviewing

Group Long-drink; Group Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Forced expiratory volume in 1 second/Forced vital capacity \> 0.7;
• Medically stable.
• Age \<18 years;

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Nutricia Research: collaborator

Study Sites (1)

Maastricht University Medical Centre+ (MUMC+)

Maastricht, Limburg, 6202 AZ, Netherlands

RECRUITING

Related Publications (2)

• van Iersel LEJ, Beijers RJHCG, Simons SO, Schuurman LT, Shetty SA, Roeselers G, van Helvoort A, Schols AMWJ, Gosker HR. Characterizing gut microbial dysbiosis and exploring the effect of prebiotic fiber supplementation in patients with COPD. Eur J Nutr. 2025 Jun 7;64(5):210. doi: 10.1007/s00394-025-03733-7.

  PMID: 40481968 DERIVED

• Beijers RJ, van Iersel LEJ, Schuurman LT, Hageman RJJ, Simons SO, van Helvoort A, Gosker HR, Schols AM. Effect of targeted nutrient supplementation on physical activity and health-related quality of life in COPD: study protocol for the randomised controlled NUTRECOVER trial. BMJ Open. 2022 Mar 16;12(3):e059252. doi: 10.1136/bmjopen-2021-059252.

  PMID: 35296491 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Dietary Supplements; Counseling; Motivational Interviewing

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Directive Counseling

Study Officials

• Annemie Schols, Prof. dr.

  Maastricht UMC+ / NUTRIM, Department of Respiratory Medicine

  STUDY DIRECTOR

Central Study Contacts

Rosanne Beijers, Dr

CONTACT

+31433882990; r.beijers@maastrichtuniversity.nl

Harry Gosker, Dr

CONTACT

+31433884298; h.gosker@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Next to the 166 COPD patients that receive the nutritional supplement, a subgroup of 30 healthy controls will be included for baseline comparison of the microbiome composition. These healthy controls will not be included in the intervention arm.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 16, 2019
• Study Start: February 19, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)