The Assessment of Nutritional Status of Patients With IPF
August 17, 2024 updated by: İrem Çağla Özel
The Assessment of Nutritional Status of Patients With IPF and The Effectiveness of Nutritional Support
The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated.
A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, hand dynamometer, pulmonary function, and food frequency. Also quality of life were assessed by SGRQ. Tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Idiopathic pulmonary fibrosis (IPF) is an irreversible interstitial lung disease of unknown etiology, characterized by progressive loss of lung function.
IPF is a disease of advanced age.
Preliminary studies of IPF indicate that nutritional status may affect quality of life and prognosis, but the clinical significance of nutritional status has not been investigated.
Weight loss is recognized as a common complication of IPF.
There is no study that comprehensively evaluates the nutritional status of IPF patients in Turkey.
The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling.
In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated.
A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, dynamometer, pulmonary function, and several questionnaires.
so quality of life were assessed by SGRQ.
All measurements were taken at the baseline.
Then, tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.
Study Type
Interventional
Enrollment (Actual)
31
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 Locations
-
-
-
Ankara, Turkey
- Atatürk Sanatorium Training and Research Hospital
-
-
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:
- Patients diagnosed with IPF
Exclusion Criteria:
- Not giving written consent
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: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Dependent Sample
Before-after measurements will be made in the dependent sample.
|
Tailored Dietary Counselling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function
Time Frame: 12 weeks
|
The effect of dietary counselling on change from baseline in FVC values at 12 weeks were assessed.
|
12 weeks
|
|
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function-2
Time Frame: 12 weeks
|
The effect of dietary counselling on change from baseline in DLCO values at 12 weeks were assessed.
|
12 weeks
|
|
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on BMI
Time Frame: 12 weeks
|
The effect of dietary counselling on change from baseline in BMI (kg/m2) at 12 weeks were assessed.
|
12 weeks
|
|
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Body Composition
Time Frame: 12 weeks
|
The effect of dietary counselling on change from baseline in body composition measured by BIA at 12 weeks were assessed.
|
12 weeks
|
|
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Energy Intake
Time Frame: 12 weeks
|
The effect of dietary counselling on change from baseline in energy intake (kcal/day) at 12 weeks were assessed.
|
12 weeks
|
|
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Dietary Intake
Time Frame: 12 weeks
|
The effect of dietary counselling on change from baseline in carbohydrate, protein and fat intake (kcal/day) at 12 weeks were assessed.
|
12 weeks
|
|
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on HRQL
Time Frame: 12 weeks
|
The effect of dietary counselling on change from baseline in St. George Respiratory Questionnaire (SGRQ) score at 12 weeks were assessed.
Scores range from 0-100.
While score of zero indicates normal, and a score of 100 indicates impaired quality of life.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nurcan Yabancı Ayhan, PhD, Ankara University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 5, 2023
Primary Completion (Actual)
June 5, 2024
Study Completion (Actual)
June 5, 2024
Study Registration Dates
First Submitted
August 9, 2024
First Submitted That Met QC Criteria
August 17, 2024
First Posted (Actual)
August 20, 2024
Study Record Updates
Last Update Posted (Actual)
August 20, 2024
Last Update Submitted That Met QC Criteria
August 17, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- İ06-370-23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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