Protein Supplementation to Enhance Exercise Capacity in COPD

University College London (UCL)

Status: Completed

Conditions: COPD

Treatments: Dietary Supplement: fortisip compact protein; Dietary Supplement: preOp

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04027413

18/LO/1842

Details and patient eligibility

About

Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease.

Pulmonary Rehabilitation (PR) is a six-week supervised group exercise and education class. PR is an effective intervention in COPD to reduce symptoms, improve exercise performance and prevent exacerbation. Exercise intolerance/limitation is one of the commonest issues with COPD patients and this may be compounded by reduced muscle mass and malnutrition. COPD patients lose body weight and skeletal muscle mass which leads to muscle weakness and dysfunction, thus impacting functional ability and quality of life. Muscle weakness is caused by a prolonged sedentary lifestyle and voluntary immobilization. Importantly, being under-weight is associated with an increased risk of mortality in COPD.

Nutritional supplementation have been used to overcome malnutrition in COPD patients. It has been shown that nutritional support integrated with exercise training can improve exercise activity, decreased the risk of mortality, and improve muscle strength in undernourished COPD patients. However, uptake of nutritional supplementation during pulmonary rehabilitation, where the potential benefit may be greatest, has been limited by the absence of rigorous evidence-based studies supporting use.

Investigators want to investigate the effect of a nutritional supplement during a PR program on exercise capacity in COPD patients. Investigators will collect demographic data, distribute questionnaires, measure exercise performance, and some additional measurements.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed COPD (post-bronchodilator forced vital capacity in one second: forced vital capacity ratio <0.7)
2. >10 smoking pack year history.
3. Enrolling on a pulmonary rehabilitation programme.
4. Age of 18 and above.

Exclusion criteria

1. Patients with any physical or mental health disorders preventing compliance with trial protocol.
2. Unable to communicate in English
3. Malabsorption syndrome
4. Unable to perform the Incremental Shuttle Walk Test
5. Patients already using other types of oral dietary supplement, under the care of a dietitian.
6. Galactosaemia (contraindication)
7. Known cow's milk protein allergy or lactose intolerance
8. BMI >30kg/m2 without recent weight loss of >5%

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

Placebo/ Control

Placebo Comparator group

Description:

participants in this group will receive carbohydrate product which does not include protein at all

Treatment:

Dietary Supplement: preOp

Intervention group

Experimental group

Description:

Participants in this group will receive high protein product

Treatment:

Dietary Supplement: fortisip compact protein