Nutritional Supplementation in Patients With Chronic Respiratory Disease

February 1, 2024 updated by: Ke-Yun, Chao, Fu Jen Catholic University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 24352
        • Recruiting
        • Fu Jen Catholic University Hospital, Fu Jen Catholic University
        • Contact:
        • Principal Investigator:
          • Ke-Yun Chao, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard pulmonnary rehabilitation group
Received routine pulmonnary rehabilitation
Other: Standard pulmonnary rehabilitation
Undergo routine pulmonary rehabilitation without dietary intervention
Experimental: Nutritional supplementation intervention group
Received regular pulmonnary rehabilitation plus healthy dietary recommendations
Other: Nutritional supplementation intervention
Receive personalized dietary guidelines based on indirect calorimetry assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting energy expenditure
Time Frame: 15 minutes
Basal metabolic rate
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University

Investigators

  • Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

October 29, 2023

First Submitted That Met QC Criteria

October 29, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJUH112271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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