COPDNCT04027413
Protein Supplementation to Enhance Exercise Capacity in COPD
A study testing fortisip compact protein and preOp in people with COPD, run by University College, London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- fortisip compact protein and preOp
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2019to 2 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed COPD (post-bronchodilator forced vital capacity in one second: forced vital capacity ratio <0.7)
- >10 smoking pack year history.
- Enrolling on a pulmonary rehabilitation programme.
- Age of 18 and above.
Who cannot join
- Patients with any physical or mental health disorders preventing compliance with trial protocol.
- Unable to communicate in English
- Malabsorption syndrome
- Unable to perform the Incremental Shuttle Walk Test
- Patients already using other types of oral dietary supplement, under the care of a dietitian.
- Galactosaemia (contraindication)
- Known cow's milk protein allergy or lactose intolerance
- BMI >30kg/m2 without recent weight loss of >5%
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central and North West London Foundation Trust
London, NW1 0PE
About this study
Official title: A Double-Blind, Randomised, Placebo-Controlled Trial of Protein Supplementation to Enhance Exercise Capacity in Chronic Obstructive Pulmonary Disease
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.
Read more
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.
- Conditions
- COPD
- Being tested
- fortisip compact protein, preOp
- Keywords
- Pulmonary Rehabilitation, Nutrtional supplements
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortisip compact proteinDietary supplement
(24% protein; 41% carbohydrate; 35% fat)
preOpDietary supplement
(100% carbohydrate).
| Study group | Role | What they receive |
|---|---|---|
| Placebo/ Control | Placebo comparator | participants in this group will receive carbohydrate product which does not include protein at all Receives: Dietary Supplement: preOp |
| Intervention group | Experimental | Participants in this group will receive high protein product Receives: Dietary Supplement: fortisip compact protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
The difference in change of exercise capacity before and and after pulmonary rehabilitation between intervention and control groups measured by Incremental Shuttle Walk Test.
Measured: 12 weeks
Secondary outcomes (18)
Peripheral muscle strength
The difference in change of peripheral muscle strength Before and and after pulmonary rehabilitation between intervention and control groups measured by Hand Dynamometer.
Measured: 12 weeks
Rectus femoris muscle cross-sectional
The difference in change of Rectus femoris muscle cross-sectional area before and and after pulmonary rehabilitation between intervention and control groups measured by portable ultrasound.
Measured: 12 weeks
Body composition
The difference in change of body composition fat mass (FM) before and and after pulmonary rehabilitation between intervention and control groups measured by a device called Bodystat.
Measured: 12 weeks
Physical activity
The difference in change of physical activity before and and after pulmonary rehabilitation between intervention and control groups measured by step-counter (YAMAX SW200).
Measured: 14 days
Health-related quality of life
The difference in change of health-related quality before and after pulmonary rehabilitation between intervention and control groups measured by Hospital Anxiety and Depression Scale. consists of seven items for anxiety and seven items for depression, each item has a score from 0-3.This means that a person can score between 0 and 21 for either abnormal, respectively. 0-7 = Normal, 8-10 = Borderline abnormal and 11-21 = Abnormal
Measured: 12 weeks
Body circumferences
The difference in change of waist circumference before and and after pulmonary rehabilitation between intervention and control groups measured by a tape.
Measured: 12 weeks
Body composition
The difference in change of body composition fat free mass (FFM) before and and after pulmonary rehabilitation between intervention and control groups measured by a device called Bodystat.
Measured: 12 weeks
Body composition
The difference in change of body composition fat free mass index (FFMI) before and and after pulmonary rehabilitation between intervention and control groups measured by a device called Bodystat.
Measured: 12 weeks
Body circumferences
The difference in change of hip circumference before and and after pulmonary rehabilitation between intervention and control groups measured by a tape.
Measured: 12 weeks
Body circumferences
The difference in change of mid-thigh circumference before and and after pulmonary rehabilitation between intervention and control groups measured by a tape.
Measured: 12 weeks
Health-related quality of life
The difference in change of health-related quality before and after pulmonary rehabilitation between intervention and control groups measured by the COPD Assessment Test Questionnaire.
Measured: 12 weeks
Health-related quality of life
The difference in change of health-related quality before and after pulmonary rehabilitation between intervention and control groups measured by St. George's Respiratory Questionnaire.
Measured: 12 weeks
intervention compliance
participants intervention compliance will be assessed by sheet
Measured: 6 weeks
Food intake
Food intake for 3 consecutive days before, during, and after PR by food diary
Measured: 12 weeks
Lower limb function
The difference in change of lower limb function before and after pulmonary rehabilitation between intervention and control groups measured Sit to Stand - Five Test.
Measured: 12 weeks
Malnutrition risk
The difference in change of Malnourished risk before and after pulmonary rehabilitation between intervention and control groups measured Malnutrition Universal Screening Tool .
Measured: 12 weeks
Disability associated with breathlessness
The difference in change of Disability associated with breathlessness before and after pulmonary rehabilitation between intervention and control groups measured by Medical Research Council breathlessness scale .
Measured: 12 weeks
Body weight
The difference in change of body weight before and after pulmonary rehabilitation between intervention and control groups measured by digital scales.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start7 Jan 2019
- Primary completion23 Mar 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised using a web-based service called 'sealed envelope' and stratified BMI less and equal or more than 20 kg/m2 to control group or interventional group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027413
- Sponsor's protocol ID
- 18/LO/1842
- Status last verified
- Oct 2020
- First submitted
- 27 Jun 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Placebo-Controlled Trial of Protein Supplementation to Enhance Exercise Capacity in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04027413
- Acronym / sponsor ID
- 18/LO/1842
- Conditions
- COPD
- Keywords
- Pulmonary Rehabilitation, Nutrtional supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Nutricia, Inc.
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomised using a web-based service called 'sealed envelope' and stratified BMI less and equal or more than 20 kg/m2 to control group or interventional group.
| Arm | Type | Receives |
|---|---|---|
| Placebo/ Control | Placebo comparator | Dietary Supplement: preOpparticipants in this group will receive carbohydrate product which does not include protein at all |
| Intervention group | Experimental | Dietary Supplement: fortisip compact proteinParticipants in this group will receive high protein product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed COPD (post-bronchodilator forced vital capacity in one second: forced vital capacity ratio <0.7)
- >10 smoking pack year history.
- Enrolling on a pulmonary rehabilitation programme.
- Age of 18 and above.
Key exclusion criteria (8 listed)
- Patients with any physical or mental health disorders preventing compliance with trial protocol.
- Unable to communicate in English
- Malabsorption syndrome
- Unable to perform the Incremental Shuttle Walk Test
- Patients already using other types of oral dietary supplement, under the care of a dietitian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fortisip compact protein(24% protein; 41% carbohydrate; 35% fat) | Dietary supplement | Intervention group |
| preOp(100% carbohydrate). | Dietary supplement | Placebo/ Control |
Primary outcome
Exercise capacity
Time frame: 12 weeks
The difference in change of exercise capacity before and and after pulmonary rehabilitation between intervention and control groups measured by Incremental Shuttle Walk Test.
18 secondary outcomes
Peripheral muscle strength
Time frame: 12 weeks
Rectus femoris muscle cross-sectional
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
Physical activity
Time frame: 14 days
Health-related quality of life
Time frame: 12 weeks
Body circumferences
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
Body circumferences
Time frame: 12 weeks
Body circumferences
Time frame: 12 weeks
Health-related quality of life
Time frame: 12 weeks
Health-related quality of life
Time frame: 12 weeks
intervention compliance
Time frame: 6 weeks
Food intake
Time frame: 12 weeks
Lower limb function
Time frame: 12 weeks
Malnutrition risk
Time frame: 12 weeks
Disability associated with breathlessness
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fortisip compact protein and preOp in people with COPD, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.