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

NCT02251496 | Completed Results

• 1 other identifier: COPD-141316051
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Malnutrition

Keywords

Malnutrition; Chronic obstructive pulmonary disease; Nutrition Therapy; Oral Nutrition Supplement; Food

Outcome Measures

Primary Outcomes (1)

• Weight Changes

  Weight changes from baseline and one year from admission to the hospital

  baseline and one year from admission to the hospital

Secondary Outcomes (1)

• Health Related Quality of Life (HRQoL)

  baseline and one year from admission to the hospital

Study Arms (2)

Oral nutrition supplement (ONS-group)

ACTIVE COMPARATOR

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)

In between meals snacks (Snacks-group)

ACTIVE COMPARATOR

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)

Interventions

In between meals snacks (Snacks-group) OTHER

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).

In between meals snacks (Snacks-group)

Oral nutrition supplement (ONS-group) OTHER

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).

Oral nutrition supplement (ONS-group)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Iceland: lead

Study Sites (1)

The Department of Thoracic Medicine at Landspítali

Reykjavik, 101, Iceland

Location

Related Publications (1)

• Ingadottir AR, Beck AM, Baldwin C, Weekes CE, Geirsdottir OG, Ramel A, Gislason T, Gunnarsdottir I. Oral nutrition supplements and between-meal snacks for nutrition therapy in patients with COPD identified as at nutritional risk: a randomised feasibility trial. BMJ Open Respir Res. 2019 Jan 3;6(1):e000349. doi: 10.1136/bmjresp-2018-000349. eCollection 2019.

  PMID: 30687503 RESULT

MeSH Terms

Conditions

Malnutrition; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Áróra Rós Ingadóttir
• Organization: University of Iceland

aroraros@landspitali.is

8461601

Study Officials

• Áróra R Ingadóttir, Master

  Unit for Nutrition Research (UNR)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist M.Sc

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 19, 2021
• Results First Posted: January 19, 2021

Record last verified: 2020-12

Locations

IC (1)