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Resting Energy Expenditure in Patients With Cystic Fibrosis: A Pilot Study

Resting Energy Expenditure in Patients With Cystic Fibrosis: A Pilot Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03699982
Enrollment
10
Registered
2018-10-09
Start date
2018-10-10
Completion date
2020-01-20
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis

Brief summary

Cystic fibrosis is an inherited disorder that causes severe damage to the lungs, digestive system, and other organs in the body. Individuals with cystic fibrosis often have poor weight gain and growth that can negatively impact health further by worsening lung function. Additionally, persons with the disease typically need more than the usual calories on a daily basis. Most institutions estimate these patients' caloric needs using weight, age, and sex based mathematical formulae. However, numerous studies show that use of these formulae often yields inaccurate caloric values. Use of indirect calorimetry may give more accurate estimates of caloric needs in patients with cystic fibrosis. The aim of our study is to assess the accuracy of caloric estimates generated using one such widely used mathematical formula, the Harris-Benedict equation, and to compare this calorie value with that obtained from indirect calorimetry testing in pediatric and adult patients with cystic fibrosis. Study investigators will use the newly calculated caloric requirements in dietary counseling. Changes in weight and lung function after 3 months will be compared to participants' historical changes.

Interventions

OTHERDaily calorie target based on resting energy expenditure

Resting Energy Expenditure will be determined using the Harris-Benedict formula and indirect calorimetry testing. Additionally, a 48 Hour Dietary Recall will be completed to estimate approximate caloric intake at baseline. Participants will be instructed to increase their daily calorie intake based on the highest REE/caloric intake, whether by indirect calorimetry, the Harris-Benedict formula, or patient's estimated current caloric intake.

Sponsors

CAMC Health System
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Patients with cystic fibrosis who are equal to or older than six years of age presenting to West Virginia University-Charleston Cystic Fibrosis Center for their regularly scheduled appointments/check-ups. * Patients at the Cystic Fibrosis Center for at least 12 months.

Exclusion criteria

* Patients with cystic fibrosis who are younger than 6 years of age. * Patients without cystic fibrosis. * Patients currently pregnant. * Cystic fibrosis patients with significant disease exacerbation (such as needing oral steroids or antibiotics, hospital admission within 30 days) or patients who currently having the flu or a serious upper respiratory infection.

Design outcomes

Primary

MeasureTime frameDescription
Resting energy expenditure estimation1 hourResting energy expenditure will be obtained using indirect calorimetry and the Harris-Benedict Equation.
Morphological variable changes3 monthsWeight/height/BMI changes after 3 months of intervention and historical weight/height/BMI changes occurring during the 12 preceding months (reported as 3 month means).
Changes in pulmonary function status3 monthsChanges in pulmonary function status, including FEV1%, after 3 months of intervention and historical pulmonary function status changes occurring during the 12 preceding months (reported as 3 month means).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026