Chronic Lung DiseaseNCT06112730
Nutritional Supplementation in Patients With Chronic Respiratory Disease
A study testing Standard pulmonnary rehabilitation and Nutritional supplementation intervention in people with Chronic Lung Disease, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the nutritional status of patients with chronic pulmonary disease undergoing regular outpatient pulmonary rehabilitation. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Lung Disease
- What is being tested?
- Standard pulmonnary rehabilitation and Nutritional supplementation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Oct 2023to 24 Jun 2024
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 45 and 80 years
- A written informed consent
- Pre-COPD or COPD stages I-IV as per the 2023 GOLD guidelines
- Recieved pulmonary rehabilitation at least three months
- Unwilling to nutritional outpatient assessment
Who cannot join
- Diagnosed with neuromuscular diseases
- Emergency room visits or hospitalizations for exacerbation of respiratory disease within three months
- Inability to cooperate with cardiopulmonary exercise testing
- Significant malnutrition or low BMI
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
Official title: Nutritional Supplementation With Indirect Calorimetry During Pulmonary Rehabilitation in Patients With Chronic Respiratory Disease
The aim of this study is to investigate the nutritional status of patients with chronic pulmonary disease undergoing regular outpatient pulmonary rehabilitation.
Read the detailed description
Background：
Exercise limitation due to impaired respiratory function is a common problem for COPD patients, and reduced muscle mass and malnutrition can exacerbate symptoms, impacting their functional ability and quality of life. Underweight COPD patients have an increased risk of mortality and acute exacerbations. Therefore, monitoring the body composition, nutritional status, and metabolic state of COPD patients and providing adequate nutritional support are crucial aspects of COPD management.Compared to healthy older adults, COPD patients require higher protein intake. Most studies have focused on analyzing body composition, respiratory and limb muscle strength, exercise performance, physical activity, lung function, emotional perception, and self-perceived scales, with limited assessment and exploration of calorie intake. Moreover, calorie intake estimation has mostly relied on formulas, lacking personalized and accurate assessment through indirect calorimetry.
Study Design：
This study is a single-center, prospective, randomized controlled trial.
Methods：
COPD patients who meet the inclusion criteria will be enrolled and randomly assigned to either the nutritional supplementation intervention group (experimental group) or the standard pulmonary rehabilitation group (control group). The experimental group will receive personalized dietary guidelines based on indirect calorimetry assessment by a nutritionist, while the control group will undergo routine pulmonary rehabilitation without dietary intervention. The study will follow up for a duration of 12 weeks, collecting data on cardiopulmonary physiological parameters, body composition, muscle strength, exercise performance, and indirect calorimetry assessment. Additionally, we will calculate the differences in recommended calorie intake between formula estimation and indirect calorimetry.
Effect：
We anticipate that indirect calorimetry will yield different results for calorie estimation compared to weight estimation and the Harris-Benedict equation. The nutritional supplementation intervention is expected to lead to improved changes in body composition, enhanced exercise performance and muscle strength, as well as better cardiopulmonary physiological parameters and self-perceived ratings.
Key words：
Chronic obstructive pulmonary disease, pulmonary rehabilitation, nutritional supplementation, indirect calorimetry
- Conditions
- Chronic Lung Disease
- Being tested
- Standard pulmonnary rehabilitation, Nutritional supplementation intervention
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary rehabilitation, Nutritional supplementation, Indirect calorimetry
- 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.
Standard pulmonnary rehabilitationOther
Undergo routine pulmonary rehabilitation without dietary intervention
Nutritional supplementation interventionOther
Receive personalized dietary guidelines based on indirect calorimetry assessment
| Study group | Role | What they receive |
|---|---|---|
| Standard pulmonnary rehabilitation group | Active comparator | Received routine pulmonnary rehabilitation Receives: Other: Standard pulmonnary rehabilitation |
| Nutritional supplementation intervention group | Experimental | Received regular pulmonnary rehabilitation plus healthy dietary recommendations Receives: Other: Nutritional supplementation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting energy expenditure
Basal metabolic rate
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start30 Oct 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112730
- Sponsor's protocol ID
- FJUH112271
- Status last verified
- Feb 2025
- First submitted
- 29 Oct 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplementation With Indirect Calorimetry During Pulmonary Rehabilitation in Patients With Chronic Respiratory Disease
- ClinicalTrials.gov ID
- NCT06112730
- Acronym / sponsor ID
- FJUH112271
- Conditions
- Chronic Lung Disease
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary rehabilitation, Nutritional supplementation, Indirect calorimetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 1 Nov 2023 (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.
The aim of this study is to investigate the nutritional status of patients with chronic pulmonary disease undergoing regular outpatient pulmonary rehabilitation.
Detailed description
Background：
Exercise limitation due to impaired respiratory function is a common problem for COPD patients, and reduced muscle mass and malnutrition can exacerbate symptoms, impacting their functional ability and quality of life. Underweight COPD patients have an increased risk of mortality and acute exacerbations. Therefore, monitoring the body composition, nutritional status, and metabolic state of COPD patients and providing adequate nutritional support are crucial aspects of COPD management.Compared to healthy older adults, COPD patients require higher protein intake. Most studies have focused on analyzing body composition, respiratory and limb muscle strength, exercise performance, physical activity, lung function, emotional perception, and self-perceived scales, with limited assessment and exploration of calorie intake. Moreover, calorie intake estimation has mostly relied on formulas, lacking personalized and accurate assessment through indirect calorimetry.
Study Design：
This study is a single-center, prospective, randomized controlled trial.
Methods：
COPD patients who meet the inclusion criteria will be enrolled and randomly assigned to either the nutritional supplementation intervention group (experimental group) or the standard pulmonary rehabilitation group (control group). The experimental group will receive personalized dietary guidelines based on indirect calorimetry assessment by a nutritionist, while the control group will undergo routine pulmonary rehabilitation without dietary intervention. The study will follow up for a duration of 12 weeks, collecting data on cardiopulmonary physiological parameters, body composition, muscle strength, exercise performance, and indirect calorimetry assessment. Additionally, we will calculate the differences in recommended calorie intake between formula estimation and indirect calorimetry.
Effect：
We anticipate that indirect calorimetry will yield different results for calorie estimation compared to weight estimation and the Harris-Benedict equation. The nutritional supplementation intervention is expected to lead to improved changes in body composition, enhanced exercise performance and muscle strength, as well as better cardiopulmonary physiological parameters and self-perceived ratings.
Key words：
Chronic obstructive pulmonary disease, pulmonary rehabilitation, nutritional supplementation, indirect calorimetry
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard pulmonnary rehabilitation group | Active comparator | Other: Standard pulmonnary rehabilitationReceived routine pulmonnary rehabilitation |
| Nutritional supplementation intervention group | Experimental | Other: Nutritional supplementation interventionReceived regular pulmonnary rehabilitation plus healthy dietary recommendations |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 45 and 80 years
- A written informed consent
- Pre-COPD or COPD stages I-IV as per the 2023 GOLD guidelines
- Recieved pulmonary rehabilitation at least three months
- Unwilling to nutritional outpatient assessment
Key exclusion criteria (4 listed)
- Diagnosed with neuromuscular diseases
- Emergency room visits or hospitalizations for exacerbation of respiratory disease within three months
- Inability to cooperate with cardiopulmonary exercise testing
- Significant malnutrition or low BMI
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 |
|---|---|---|
| Standard pulmonnary rehabilitationUndergo routine pulmonary rehabilitation without dietary intervention | Other | Standard pulmonnary rehabilitation group |
| Nutritional supplementation interventionReceive personalized dietary guidelines based on indirect calorimetry assessment | Other | Nutritional supplementation intervention group |
Primary outcome
Resting energy expenditure
Time frame: 15 minutes
Basal metabolic rate
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard pulmonnary rehabilitation and Nutritional supplementation intervention in people with Chronic Lung Disease, run by Fu Jen Catholic University at 1 site in Taiwan.
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 5 inclusion and 4 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 27 Feb 2026. 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 Taiwan. 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. 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?
Resting energy expenditure (time frame: 15 minutes). 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 27 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.