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COPD: Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks. (COPD)

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ClinicalTrials.gov Identifier: NCT02251496
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Áróra Rós Ingadóttir, University of Iceland

Brief Summary:
At least one fifth of patients in European hospitals are malnourished. Malnutrition is associated with negative consequences, including higher rates of complications, longer hospital stay, impaired wound healing and increased mortality with consequent effects on costs of healthcare. Evidence suggests that there may be benefits to some malnourished patients from receiving oral nutrition supplements in the short-term but it is not known whether these benefits can be sustained and indeed whether similar benefits may be achieved using food-based interventions of lower cost. The overall objective of the study is to compare two nutritional interventions among malnourished patients with COPD (n=200); oral nutrition supplement (ONS) vs. energy and protein dense in-between meals snack during hospitalisation and at home. Subjects will be followed for one year. The primary endpoint is weight change. Secondary endpoints include forced expiratory volume in one second, forced vital capacity, six-minute walk distance, hand-grip strength, health related quality of life, length of hospital stay, energy- and protein intake, readmissions to the hospital and acute exacerbation. No studies are available comparing the supply of ONS to malnourished patients with COPD compared with the provision of regular food (in-between meals snacks). The results of the study will provide important information that might improve nutrition care in the hospital setting as well as after discharge from the hospital

Condition or disease Intervention/treatment Phase
Malnutrition Other: In between meals snacks (Snacks-group) Other: Oral nutrition supplement (ONS-group) Not Applicable

Detailed Description:

Patients with established COPD admitted to the Department of Pulmonary Medicine at Landspitali National University Hospital from September 2014-September 2016 will be screened for malnutrition using the NRS2002 screening tool, recommended by ESPEN. Those identified at risk of malnutrition and are able to give informed consent will be recruited. According to the Hospital statistics and previous studies on the frequency of malnutrition in this patient group, the time frame for recruitment is long enough to recruit 200 subjects who will be randomised into the two study groups (~ 3 subjects per week).

The following baseline data will be collected in order to identify possible confounders. This will include; socio-demographic data (age, gender, civil status, household size, family and social network); major medical diagnosis; use of medication; GOLD score (Global Initiative for Chronic Obstructive Lung Disease), depressive symptoms, cognition), additional discharge interventions (e.g. outgoing hospital teams, day care with exercise); and use of oral nutritional supplements.

Inclusion criteria are:

  • Newly admitted patients > 18 years old who were at nutritional risk according to the validated nutritional risk screening tool (NRS-2002, score 3+)
  • Able to eat orally
  • An anticipated length of hospitalization of > 3 days
  • Sufficient language proficiency

Exclusion criteria are:

  • Dysphagia
  • Food allergy or intolerance
  • Anatomical obstructions preventing oral food intake Exclusion during follow-up: Subjects who withdraw their consent to participate.

Outcome measures:

The primary endpoint is weight changes up to one year from admission to the hospital. Secondary endpoints include forced expiratory volume in one second (FEV1), forced vital capacity (FVC), six-minute walk distance, hand-grip strength, health related quality of life (HRQoL), length of hospital stay, nutritional status, energy- and protein intake, readmissions to the hospital in within 30 days, as well as the total number of readmissions to the hospital and acute exacerbation during follow-up. Functional outcome measurements will be conducted by trained research assistant in collaboration with the PhD student. Information about background diets, HRQoL as well as compliance to the intervention diets will be gathered by the PhD and MS students.

Measurements will be conducted at admission to the hospital (baseline measurements) and before discharge from the hospital. Clinical examinations at Landspitali National University Hospital are planned 3, 6 and 12 months after discharge from the hospital. All together we aim at having five measurement points for each subject. Each examination will take ~ 80 minutes (30 min for the FEV1 and FVC tests, 20 min for the walking test and measurement of hand-grip strength, and 30 min for the 24-hour recalls and HRQoL questionnaires). Additionally, the subjects will be contacted on at least two other occasions by phone, in weeks 2 and 6 (each interview ~20 min).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks, Weight Changes and Functional Capacity in Chronic Obstructive Pulmonary Disease; Randomized Controlled Dietary Intervention
Study Start Date : September 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Oral nutrition supplement (ONS-group)
The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
Other: Oral nutrition supplement (ONS-group)
The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).

Active Comparator: In between meals snacks (Snacks-group)
In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
Other: In between meals snacks (Snacks-group)
In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).




Primary Outcome Measures :
  1. Weight changes [ Time Frame: One year from admission to the hospital ]
    Weight changes up to one year from admission to the hospital


Secondary Outcome Measures :
  1. Health related quality of life (HRQoL) [ Time Frame: One year from admission to the hospital. ]
    St. George's Respiratory Questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly admitted patients > 18 years old who were at nutritional risk according to the validated nutritional risk screening tool (NRS-2002, score 3+)
  • Able to eat orally
  • An anticipated length of hospitalization of > 3 days
  • Sufficient language proficiency

Exclusion Criteria:

  • Dysphagia
  • Food allergy or intolerance
  • Anatomical obstructions preventing oral food intake

Exclusion during follow-up: Subjects who withdraw their consent to participate.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251496


Locations
Iceland
The Department of Thoracic Medicine at Landspítali
Reykjavík, Iceland, 101
Sponsors and Collaborators
University of Iceland
Investigators
Principal Investigator: Áróra R Ingadóttir, Master Unit for Nutrition Research (UNR)

Responsible Party: Áróra Rós Ingadóttir, Nutritionist M.Sc, University of Iceland
ClinicalTrials.gov Identifier: NCT02251496     History of Changes
Other Study ID Numbers: COPD-141316051
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Keywords provided by Áróra Rós Ingadóttir, University of Iceland:
Malnutrition
Chronic obstructive pulmonary disease
Nutrition Therapy
Oral Nutrition Supplement
Food

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Malnutrition
Lung Diseases
Respiratory Tract Diseases
Nutrition Disorders