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Clinical Trials/NCT06563011
NCT06563011
Completed
Not Applicable

The Assessment of Nutritional Status of Patients With IPF and The Effectiveness of Nutritional Support

İrem Çağla Özel1 site in 1 country31 target enrollmentSeptember 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Pulmonary Fibrosis
Sponsor
İrem Çağla Özel
Enrollment
31
Locations
1
Primary Endpoint
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function-2
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 5, 2023
End Date
June 5, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
İrem Çağla Özel
Responsible Party
Sponsor Investigator
Principal Investigator

İrem Çağla Özel

Principal Investigator

Ankara University

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with IPF

Exclusion Criteria

  • Not giving written consent

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

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.

Study Sites (1)

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